Associate Director / Senior Clinical Research Manager, Biotechnology
Redwood City, CA area

We are a growing Bay area Biotechnology (Diagnostics) company with an immediate need to hire a full time Associate Director / Sr. Clinical Research Manager to help bring our products to market.

Job Responsibilities Include:

*Manage study start up activities for a multi-center, US based diagnostic study currently enrolling.

*Perform CRO oversight and manage clinical research staff.

*Be responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations, statues and SOPs.

*Create project specific documents and tools.

*Assist with the development of new diagnostic studies, including protocol writing, informed consent development, plans, CRFs, monitoring conventions, tracking forms, and other study related documents.

*Manage study qualification visits for the purpose of assessing the site's ability to effectively conduct the trial as per SOPs and study guidelines.

Job Requirements:

*Bachelors Degree and a minimum of 10+ years of clinical trial / clinical research experience in the biotechnology, diagnostics or medical device industry.

*Experience managing large clinical studies and managing CROs.

*Ability to work independently in a start up environment.

*Prior monitoring experience in accordance with CFR, GCP and ICH Guidelines.

This is a full time permanent (office based in the SF Bay area) position and requires up to 25% domestic travel.

We are developing human embryonic stem cell (hESC) technology to create cell based therapies for the treatment of human degenerative diseases.

The Director of Islet Cell Biology will lead a team of scientists and research associates to improve methods to differentiate hESCs into pancreatic islet cells and test these cells in both in vitro and in vivo animal models of diabetes.

This position will also be responsible for leading scientific efforts to differentiate other endodermal cell derivatives for both therapeutic and drug discovery applications.

Responsibilities:

Direct provide strategic scientific and technical leadership to a team of researchers to develop human embryonic stem cell therapeutics for diabetes

Develop protocols to improve the efficiency of differentiating islet cells and their progenitors from hESCs

With preclinical development department, lead efforts to test differentiated islet cell populations for their efficacy and safety in appropriate animal models of diabetes

Interface with collaborating scientists and physicians to develop and execute workplans to improve differentiation schemes, test preclinical safety and efficacy, and develop efficient delivery systems for hESC-derived islet cells

Interface with product development personnel to scale production of differentiation protocols for cGMP manufacture

Provide project plans and timelines

Write reports on scientific studies to support regulatory submissions

Present scientific findings to key scientific, administrative and business forums

Qualifications:

PhD in cell biology/ biochemistry/developmental biology with 7 years experience in islet cell biology and diabetes models

A working knowledge of islet cell developmental biology a must

Goal oriented individual with a positive track record in management of scientific staff

Experience in cellular and molecular therapy preferably in a biotechnology or pharmaceutical setting a definite plus

Proven experience in pancreatic differentiation and pancreatic biology a definite plus

Experience in cell culture, cellular and molecular assays to determine differentiation of stem cells

Sr. Supply Chain Manager, Biologics Monte Carlo Simulation - New Jersey

You will be responsible for strategically assessing a major biologics supply chain distributed among multiple production sites. You will be responsible for performing the following activities:

* Developing and implementing biologics Monte Carlo models and simulations for pipeline decision making.
* Integrating financial data from the supply chain in order to optimize the balance between costs and outputs.
* Analyzing long term manufacturing requirements for drug substance storage capacities.
* Leading monthly Sales and Operations planning meetings.
* Represent the Global Supply Chain organization at Manufacturing Launch team, Quality, Finance, and Regulatory meetings.
* Analyzing biologics supply chain networks integral in the manufacturing of cGMP clinical and commercial BioPharmaceutical products including mammalian cell culture & protein purification materials (growth media, reagents, chromatography equipment, filtration equipment, resins, bioreactors).
* Working with internal departments including Process Development, Process Engineering, Quality, and Finance units to gather and interpret business requirements for biologic materials.
* Leading and supporting team members of Biologics and Chemicals Sourcing teams.
* Utilizing ERP including SAP systems for budgeting, controlling and estimating raw material inventory levels and ordering supplies at appropriate intervals.

Preferred Candidate Background and Expertise:

* BS in Business Administration, Operations Management, Supply Chain Management, Engineering, or related field- MBA or MS degree preferred.
* 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry supply chain experience working on manufacturing Biologics, Biopharma, monoclonal antibody, or recombinant protein products.
* Expertise developing Monte Carlo models or similar modeling or simulation tools.
* Strong knowledge of Enterprise Resource Planning (ERP) systems with expertise in SAP.
* Experience driving continuous improvements utilizing Six Sigma methodologies.
* APICS, CPIM, or CPM certifications a plus.
* Expertise working within cGMP compliance.

Sr. Scientist, Upstream Mammalian Cell Culture Technology Transfer

You will be responsible for providing Scientific leadership and project management for multiple upstream mammalian cell culture technology transfer processes for the commercial manufacturing of monoclonal antibody and recombinant protein therapeutic products.

You will be directly responsible for managing commercial manufacturing technology transfer activities for cGMP upstream mammalian cell culture manufacturing activities ranging from seed banking, inoculum, and bioreactor/fermentor operations. Technology transfer activities involve managing incoming biologic processes and transfer out to 3rd party Contract Manufacturing Organizations (CMO). You will also be responsible for running upstream mammalian cell culture studies, process validation activities, and process characterization activities of recombinant protein products. This is a critical position where you will be directly involved in developing and supporting processes for late stage Phase III clinical trial materials. Other responsibilities include contributing to CMC sections of NDA & BLA filings, participating in Pre Approval Inspections, and participating in FDA audits.

Preferred Candidate Background and Expertise:

* MS or Ph.D. in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field.
* 4+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
* Experience managing downstream purification technology transfer activities with Contract Manufacturers (CMOs) and off site locations.
* Strong Scientific, Engineering, and Manufacturing troubleshooting expertise involving upstream mammalian cell culture processes for the generation of monoclonal antibody and recombinant protein therapeutic products.
* Experience contributing to CMC sections of BLA and NDA filings.
* Expertise involving Pre Approval Inspections (PAI) and FDA Audits.
* Expertise leading scale-up, technology transfer and process validation (PQ) activities.
* Expertise working within cGMP compliance and providing GMP documentation.

*** Please note - this position is located on the East Coast but not in New Jersey or Boston.  A full relocation package is provided for this position.  ***

Senior SQL Database Engineer / Architect

We are a growing non-for-profit community health organization.  We have an immediate need to hire a full time Senior Database Engineer with expertise in Business Intelligence / Online analytical processing (OLAP) Solutions.  This is a virtual home based position and requires minimal travel. 

The Senior Database Engineer will be responsible for building and managing a large healthcare data warehouse solution as well as setting the BI access layer and report collections. This individual should be familiar with data warehousing techniques to support information retrieval from multiple systems, data mapping and transformation, and setting large data sets for benchmarking and comparison.

Job Responsibilities:

*Strengthen the architecture of, while maintaining, the existing business intelligence solution.

*Increase the capabilities of the extract, transform, and load (ETL) layer to retrieve data from additional customer systems and transform to meet data standards.

*Working to lead efforts to establishing customer toolset to be used to access warehoused data for reporting and analysis.

*Working with staff, set the design of rich visual data solutions (e.g. dashboards) customer report collection.

*Technical requirements gathering to meet needs of current and future business intelligence solutions.

*Setting systems and processes to support daily extracts, maintenance, monitoring, and performance analysis required to manage a hosted warehoused data solution.

*Lead the trouble shooting, problem resolution, and data recovery activities for warehouse environment.

*Represent current and future capacity resource planning required to support the analytics solution.

*Represent the company with vendors and partner organizations as work is completed to increase the scope of the product offering.

Position Requires:

*Bachelors Degree is Required.

*Strong ETL experience and overall database experience is a must.

*Must have experience with big picture architecture.

*Recent experience designing data warehouses and OLAP solutions using Microsoft SQL Server Toolset.

*Experience developing applications that work with heterogeneous data sources, extracting data.

*Experience working with OLAP cubes and MDX Queries.

*Ability to develop complex SQL queries (ex: using various joins and sub- queries) and stored procedures (go to person for complex data queries).

*Ability to create complex reports (ex: drill down reports) and visuals using cursors and multi-dimensional objects.

*Web data analysis a plus.

*5+ Experience working on data solutions.

This is a virtual home based position with a national non-for-profit healthcare organization.  All of our employees are passionate about working in this industry and you should be too!

Associate Director, Quality Assurance
San Francisco Bay Area

The Associate Director, Quality Assurance is responsible for the GMP auditing activities, Document Control and Training, and supports the development and operation of the Quality Management System.  This individual develops and implements policies and procedures assuring GMP compliance internally (Technical and Quality operations) and of contractors by performing the above duties personally or through subordinate specialists including external contractors.

Additional Responsibilities:

Responsible for, and supervises/manages the Quality Compliance function. This includes the auditing activities as well as overall compliance.

Designs, implements and maintains quality systems ensuring global compliance requirements.

Develops and implements quality policies and standard operating procedures for auditing and training.

Establishes systems to assure compliance with domestic and international cGMP regulations.

Conducts audits (both internally and externally).

Audits regulatory submissions (CTD/NDA/BLA) for accuracy of source data.

Position Requires:

Bachelors Degree in a strong scientific discipline plus a minimum of 8-10 years experience in a management and leadership position within pharmaceutical quality compliance/quality assurance.

Trained and qualified auditor with extensive experience in conducting both internal and external audits.

Experience in writing and implementing compliance policies, procedures and quality systems is essential.

Strong knowledge of GMP regulations is a pre-requisite requirement for this position. Knowledge of GCP regulations would be an advantage.

Senior Director Quality Assurance, Pharmaceutical

We are a growing Bay area pharmaceutical company. We have an immediate need to hire a full time Senior Director of Quality Assurance with expertise in parenteral and oral dosing formulations and aseptic processing.

Responsibilities:

Provide strategic leadership and successful implementation, execution and maintenance of Quality Systems and Assurance work with the business strategy, industry standards and global regulatory expectations of a virtual pharmaceutical company that is developing products for NDA and IND submissions.

Responsible for developing processes/procedures and policies for the QA/QC group.


Responsible for overseeing the review of data and release of all clinical and commercial products and ensure that the product characteristics meet appropriate quality specifications and regulations/guidelines.

Will work closely with Regulatory Affairs and Senior Management to establish processes and systems that support collaboration and compliance across an extended partner network.

Responsible for hiring and managing internal and external personnel.

Will work in collaboration with Technical Operations, Project Management and Supply Chain Management to develop and ensure the effectiveness for Regulatory inspections.

Assures that work is performed in compliance with department SOPs and cGMPs.

Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures, SOPs and controls as they pertain to commercial drug product manufacturing at contract manufacturing organizations (CMOs).

Establishes and ensures policy at the CMOs for the adherence to CFR, EMEA, and all other government agencies.

Works independently to resolve issues with very limited direct supervision.

Schedules, supervises and conducts review of all analytical activities (including testing, validation and method/specification development) for clinical and commercial supply.

Position Requires:

Bachelors Degree and a minimum of 10+ years of Quality Assurance leadership experience in the pharmaceutical industry.

Must have experience in parenteral and oral dosing formulations.

Must have experience and be extremely knowledgeable in Aseptic processing.

Strong organizational and management skills, attention to detail, communication and interpersonal skills, and professionalism required.

Must have experience managing CMO/CROs.

Experience with analytical development and validation in support of all stages of drug development from pre-clinical to marketed product.

Extensive experience with working with external testing facilities.

Extensive experience with establishing QA/QC systems within a growing organization

Extensive experience in reviewing and evaluating data in support of clinical and commercial supply

In-depth knowledge of global cGMPs and experience with global health authority inspections as related to clinical/commercial supply chains.

Experience with NDA submissions and PAI inspections

Senior Process Development Engineer, Class III Catheter Medical Devices

This is a stellar opportunity responsible for developing and bringing to market novel class III medical devices for cardiovascular applications including novel vascular stent & catheter technologies. You will be responsible for the following activities:

* Leading process development and manufacturing of medical devices, including cardiovascular catheter, stents, and stent delivery systems.
* Developing and optimizing catheter manufacturing processes involving heat shrinking, laser welding, bonding, fusion, and nitinol materials.
* Leading Six Sigma, Lean Manufacturing, and Statistical Experimental Design activities to improve manufacturing processes and increase efficiencies.
* Developing, verifying, and validating vascular device products from process development through to successful commercialization.
* Leading projects from conception through commercial launch of medical devices by developing design and process failure mode & effects documents.
* Working with Design Engineers and Quality Engineers to successfully transfer new products into production and manufacturing.
* Leading process validation activities including writing protocols & reports, preparing master validation plans, addressing deviations & non-conformities, and utilizing advanced statistical process techniques.

Preferred Candidate Background and Expertise:

* BS or MS Degree in Mechanical Engineering or Materials Engineering.
* 5+ years of cardiovascular medical device industry experience working with vascular heart valves, catheters or stents (design, fixturing, fatigue testing, Catheters, Nitinol, Stainless Steel).
* Experience manufacturing prototype balloon catheters, vascular stents, and stent delivery systems.
* Expertise implementing Six Sigma, Lean Manufacturing, SPC, Continuous Improvement, and Statistical Experimental Design activities to improve manufacturing processes and increase efficiencies.
* Experience working within FDA, GMO & ISO guidelines (Design Controls) and compliance with internal Quality Systems. 

Vice President, Clinical and Regulatory Affairs
Northern New Jersey

We are currently retained to staff a VP, Clinical Development and Regulatory Affairs job opportunity with a growing international pharmaceutical company in Northern New Jersey. This is a full time permanent position and the client company is providing relocation for the right candidate. In this role you will wear a lot of hats and need to be very adaptable. This is an equity position and we are seeking a self-motivated pharmaceutical executive with an entrepreneurial spirit and big company experience but wanting to work for a smaller company and make a difference. The VP will be responsible for domestic (US) clinical development and regulatory affairs. Reports to US based CSO.

Job Responsibilities:

*Develop appropriate strategies to ensure goals are achieved and all documents are in compliance with FDA regulations.

*Take the lead on many regulatory initiatives involving widespread operations or policy changes.

*Review outgoing FDA correspondence (NDA, amendments, supplements) for completeness and correctness.

*Review incoming FDA correspondence, determine its distribution, and initiate appropriate response where applicable.

*Work across the drug development continuum and interface, consult, advise and provide scientific expertise to the clients in the development of their Clinical Drug processes

Position Requires:

*Executive level experience (Sr. Director, Vice President level) in the pharmaceutical industry required.

*PhD in pharmacology, toxicology or related.

*Must have successful original NDA filing experience.

*Extensive drug development experience running across the drug development continuum.

*Must have experience submitting INDs and filing IRBs.

*Must have strong knowledge of biochemical and mechanistic toxicology and understanding of clinical pharmacology and pharmacokinetics.

Manager, Regulatory Affairs, Pharmaceutical
Northern New Jersey

We are an international pharmaceutical company with a therapeutic focus in dermatology. We have an immediate need to hire a full time Manager, Regulatory Affairs.

Job Responsibilities:

*Prepare regulatory applications for clinical trials in the United States.

*Develop templates suitable for e-CTD filing.

*Prepare documentation to support domestic clinical trial applications.

*Prepare required IRB applications.

*Ensure regulatory and IRB approvals at all clinical trial sites in North America.

*File amendments to clinical trial approvals as required.

*Ensure investigational medicinal product is supplied to the study sites in compliance with regulatory approvals, including labeling, import permits where applicable.

*Assist in the development of the North American regulatory strategy

*Assist in the preparation and review of briefing documents to support meetings with the relevant regulatory bodies.

*Update documentation as required in response to IRB or Regulatory comments/questions.

*Implement quality systems to ensure that a complete history of updates is maintained.

Position Requires:

Bachelors Degree and a minimum of 5 years of recent regulatory affairs experience in the pharmaceutical industry.

Must have experience with electronic submission software and publishing systems.

Must have regulatory document writing experience.

Clinical Trial Manager, Pharmaceutical
New York

We are an established pharmaceutical company located 30 miles North of New York City. We have an immediate need to hire a full time Clinical Trial Manager to oversee the daily operations of clinical trials.

Job Responsibilities:

Clinical trial start-up, site monitoring and close-out visits.

Coordinate clinical research projects, write protocols and identify / qualify clinical sites.

Oversee the collection of data to ensure compliance with protocol including ICH, FDA and GCP regulations.

Responsible for project timelines, milestones and budget for all assigned clinical trials.

Position Requires:

Bachelors Degree and a minimum of 7+ years of pharmaceutical industry clinical research experience.

Must have strong knowledge of ICH, GCP and FDA regulations.

Must have previous clinical trial / clinical project management experience including managing clinical program budget, writing protocols and CRO oversight.

Must be willing and able to travel up to 25% with some overnights.

Senior Clinical Research Associate, Pharmaceutical
Northern New Jersey

We are an established publicly traded international pharmaceutical company with a therapeutic focus in dermatology. We have an immediate need to hire a full time Senior Clinical Research Associate (Sr. CRA) to work in our Northern New Jersey office. This is a permanent position and requires up to 20% domestic and international travel.

Job Responsibilities:

Manage preparation and execution of site initiation and monitor the progress of clinical trials through regular visits and correspondence to ensure satisfactory conduct of trials.

Collect and compile essential documents (according to ICH GCP guidelines and company SOPs) and prepare required HREC/IEC applications in a timely manner.

Ensue accountability and reconciliation of study materials and investigational medicinal product.

Report adverse events in compliance with regulatory requirements and company SOPs.

Position Requires:

Bachelors Degree and a minimum of 5 years of recent pharmaceutical industry clinical research experience.

Prior clinical site monitoring experience.

Report writing skills.

Strong knowledge of ICH, GCP guidelines and regulatory requirements.

Senior Clinical Research Associate, Biotechnology

We are a growing Bay area Biotechnology company with an immediate need to hire a full time Sr. Clinical Research Associate to help bring our products to market.

Job Responsibilities Include:

*Manage study start up activities for a multi-center, US based diagnostic study currently enrolling.

*Be responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations, statues and SOPs.

*Create project specific documents and tools.

*Assist with the development of new diagnostic studies, including protocol writing, informed consent development, plans, CRFs, monitoring conventions, tracking forms, and other study related documents.

*Conduct study qualification visits for the purpose of assessing the site's ability to effectively conduct the trial as per SOPs and study guidelines.

Job Requirements:

*Bachelors Degree and a minimum of 5 years of clinical trial monitoring experience in accordance with CFR, GCP and ICH Guidelines

*Experience managing large clinical studies and working with CROs a big plus

*Ability to travel up to 35% domestically.

Clinical Research Manager, Medical Device

We are an established international medical device firm located near South San Francisco, CA. We have an immediate need to hire a full time Clinical Research Manager with strong medical device clinical trial management experience.

Job Responsibilities:

Manage the design, implementation and monitoring of clinical trials.

Manage design and write case report forms (CRFs), protocols, informed consent forms, IRB applications and IDEs.

Select new investigators, CROs and outside vendors.

Monitor site visits and supervise investigator performance.

Ensure that CRFs are reviewed and submitted to the data management group.

Job Requires:

Bachelors Degree and a minimum of 5 years of medical device or biotechnology experience as a Clinical Research Associate with prior clinical site monitoring experience.

Current / Recent clinical project management experience.

Ability to write protocols, CRFs, etc.

Must be willing and able to travel up to 20% of the time with overnights.

Senior Process Engineer, Nutritional Food Manufacturing

This is a stellar opportunity within a thriving, growing and promising Midwest based nutritional food production company! You will be responsible for developing and leading food process innovation and process engineering activities for the successful development of brand name complex food products. Your hands on responsibilities will include:

* Working in an R&D group to develop innovative production processes involving spray dryers, dry powder blending, powder conveying, liquid processing, hydrolyzed protein processing, and liquid processing technologies.
* Developing and implementing best manufacturing practices for the scale up and qualification of manufacturing processes for dairy powder spray dry and liquid processing.
* Driving and leading plant efficiency, productivity, and yield improvement projects by implementing Six Sigma, Lean Manufacturing, and other continuous improvement initiatives.
* Providing strategic engineering insight to apply heat transfer, mass transfer, fluid flow, and process control concepts.
* Providing outstanding equipment, facilities, and utilities troubleshooting activities.

Preferred Candidate Background and Expertise:

* BS or MS degree in Chemical Engineering, Mechanical Engineering, Food Science or related field.
* 4+ years of Dairy, Food Processing, or Nutritional Products industry experience.
* Expertise applying heat transfer, mass transfer, fluid flow, and process control concepts.
* Process innovation experience working with spray dried dairy, spray dry milk, powders, or nutritional related products.
* Exceptional Project Management, Project Leadership, Process Improvement, and Capital Project Management experience.
* Process Improvement experience implementing Six Sigma methodologies involving Process Mapping, CTQ, Root Cause Analysis, Control Charts and Statistical Process Control (SPC). Six Sigma Green Belt or Six Sigma Black Belt a plus.
* Expertise working within cGMP, FDA, HACCP & OSHA compliance and providing appropriate documentation & SOPs.

*** Please note - This position is located in the Midwest but not in Chicago or St. Louis.  A full relocation package is provided for this position. ***

Automation Engineer, Medical Device
Salt Lake City, Utah - Relocation Available

We are an established medical device company located in Salt Lake City, UT. We have an immediate need to hire a full time Automation Engineer with expertise in design and implementation of automation systems for high-speed, high-volume automated production of medical devices.

Responsibilities Include:

*Design and procurement of custom process automation machines, equipment, systems and fixtures to satisfy specific requirements.

*Determine machine requirements, evaluate needs and translate them into feasible and economical equipment solutions.

*Provide knowledge on capabilities of key automation suppliers and providers of automation design and equipment manufacturing.

*Evaluate suppliers and make recommendations for selection.

*Work with Manufacturing personnel to improve performance of manufacturing systems.

*Create detailed conceptualizations, detailed designs, process maps, and tolerance analyses for form, dimensional fit, and overall functionality.

*Lead FMEA and risk analysis activities.

Position Requires:

*Bachelors Degree in Mechanical Engineering, Electrical Engineering, or equivalent and experience designing high volume automated assembly processes.

*Must have thorough understanding of strength of materials, kinematics and dynamics, vibration, fluid flow as well as plastic part assembly, bowl feeders, product handling, part transfer, cam devices, stepper/servo motors, drive systems, slide systems, sensor technologies and application, vision systems, and machine control systems.

*Fluency in PLC programming.

*Ability to initiate and manage equipment procurement and implementation projects.

*Solid modeling via Solid Works and experience with ASME Y14.5, ISO, and GD/T principles.

*Familiarity with Six Sigma, LEAN manufacturing or other vigorous quality control programs and FDA QSR/ISO 9000/ISO 13485 regulations.

Position is located in Salt Lake City, UT and relocation is available.

Senior SQL Database Engineer / Architect

We are a growing non-for-profit community health organization.  We have an immediate need to hire a full time Senior Database Engineer with expertise in Business Intelligence / Online analytical processing (OLAP) Solutions.  This is a virtual home based position and requires minimal travel. 

The Senior Database Engineer will be responsible for building and managing a large healthcare data warehouse solution as well as setting the BI access layer and report collections. This individual should be familiar with data warehousing techniques to support information retrieval from multiple systems, data mapping and transformation, and setting large data sets for benchmarking and comparison.

Job Responsibilities:

*Strengthen the architecture of, while maintaining, the existing business intelligence solution.

*Increase the capabilities of the extract, transform, and load (ETL) layer to retrieve data from additional customer systems and transform to meet data standards.

*Working to lead efforts to establishing customer toolset to be used to access warehoused data for reporting and analysis.

*Working with staff, set the design of rich visual data solutions (e.g. dashboards) customer report collection.

*Technical requirements gathering to meet needs of current and future business intelligence solutions.

*Setting systems and processes to support daily extracts, maintenance, monitoring, and performance analysis required to manage a hosted warehoused data solution.

*Lead the trouble shooting, problem resolution, and data recovery activities for warehouse environment.

*Represent current and future capacity resource planning required to support the analytics solution.

*Represent the company with vendors and partner organizations as work is completed to increase the scope of the product offering.

Position Requires:

*Bachelors Degree Required.

*Strong ETL experience and overall database experience is a must.

*Must have experience with big picture architecture.

*Recent experience designing data warehouses and OLAP solutions using Microsoft SQL Server Toolset.

*Experience developing applications that work with heterogeneous data sources, extracting data.

*Experience working with OLAP cubes and MDX Queries.

*Ability to develop complex SQL queries (ex: using various joins and sub- queries) and stored procedures (go to person for complex data queries).

*Ability to create complex reports (ex: drill down reports) and visuals using cursors and multi-dimensional objects.

*Web data analysis a plus.

*5+ Experience working on data solutions.

This is a virtual home based position with a national non-for-profit healthcare organization.  All of our employees are passionate about working in this industry and you should be too!

Senior SQL Database Engineer / Architect

We are a growing non-for-profit community health organization.  We have an immediate need to hire a full time Senior Database Engineer with expertise in Business Intelligence / Online analytical processing (OLAP) Solutions.  This is a virtual home based position and requires minimal travel. 

The Senior Database Engineer will be responsible for building and managing a large healthcare data warehouse solution as well as setting the BI access layer and report collections. This individual should be familiar with data warehousing techniques to support information retrieval from multiple systems, data mapping and transformation, and setting large data sets for benchmarking and comparison.

Job Responsibilities:

*Strengthen the architecture of, while maintaining, the existing business intelligence solution.

*Increase the capabilities of the extract, transform, and load (ETL) layer to retrieve data from additional customer systems and transform to meet data standards.

*Working to lead efforts to establishing customer toolset to be used to access warehoused data for reporting and analysis.

*Working with staff, set the design of rich visual data solutions (e.g. dashboards) customer report collection.

*Technical requirements gathering to meet needs of current and future business intelligence solutions.

*Setting systems and processes to support daily extracts, maintenance, monitoring, and performance analysis required to manage a hosted warehoused data solution.

*Lead the trouble shooting, problem resolution, and data recovery activities for warehouse environment.

*Represent current and future capacity resource planning required to support the analytics solution.

*Represent the company with vendors and partner organizations as work is completed to increase the scope of the product offering.

Position Requires:

*Bachelors Degree Required.

*Strong ETL experience and overall database experience is a must.

*Must have experience with big picture architecture.

*Recent experience designing data warehouses and OLAP solutions using Microsoft SQL Server Toolset.

*Experience developing applications that work with heterogeneous data sources, extracting data.

*Experience working with OLAP cubes and MDX Queries.

*Ability to develop complex SQL queries (ex: using various joins and sub- queries) and stored procedures (go to person for complex data queries).

*Ability to create complex reports (ex: drill down reports) and visuals using cursors and multi-dimensional objects.

*Web data analysis a plus.

*5+ Experience working on data solutions.

This is a virtual home based position with a national non-for-profit health care organization.  All of our employees are passionate about working in this industry and you should be too!

Sr. RF Embedded Software Engineer, Medical Device
Houston, TX - Relocation Available

We are an established Medical Device company located in the Houston, Texas area.  We have an immediate need to hire a full time Senior Software Engineer with expertise in Low Power RF Embedded Systems.

In this key position you will be a team leader responsible for the development of product software / firmware for innovative electronic medical devices.

Responsibilities Include:

Work on the design and development of new medical device products as well as product changes and enhancements.

Perform system architecture design, coding, conduct software / firmware testing.

Generate written test protocols and reports.

Develop Software Design Documentation in accordance with established standards and procedures

Position Requires:

Bachelors Degree in Electrical Engineering or Computer Science and expertise in the theory, design and implementation of real-time interrupt driven firmware applications.

Strong proficiency with in C programming language pertaining to real-time applications.

Experience in development of firmware for low power wireless communication systems, particularly for MICS/MEDS applications.

Experience with RF communication technologies including encryption, authentication, error detection and correction, and various networking protocols, algorithms and techniques.

Proficient with Timing analysis and simulation/measurement tools, MATLAB/Simulink, Static Analysis Logic Analyzers etc., Network Analyzers.

Knowledge of Software Reliability Engineering and Testing Techniques.

Proficiency with i2C, UART and SPI and interface development.

Working knowledge of industry standards including but not limited to IEC 62304 and ISO 13485, and medical device experience.

Sr. Manufacturing Engineer, Medical Device
Houston, TX

We are an established cardiac medical device company located in Houston, Texas. We have an immediate need to hire a full time Sr. Manufacturing Engineer with expertise in Laser Welding.

In this key engineering role you will be responsible for the optimize manufacturing of medical device products. This includes design, development and validation of manufacturing processes, tooling and fixtures in order to enhancing productivity and meet daily production schedules.

Additional Responsibilities Include:

Design and develop manufacturing processes for new products, assist in product changes and related tooling and fixtures.

Ensure zero defect level as well as low product cost.

Perform process validation activities on manufacturing processes.

Create and maintain tooling drawings and shop orders.

Ensure GMP and Quality compliance in coordination with the Document Control, R&D, and Quality Assurance.

Develop and provide Design for Manufacturability data for new products.

Ensure design transfer of new products.

Position Requires:

Bachelors Degree in Engineering and expertise in the manufacturing of Class II and Class III medical devices.

Experience with cardiac medical devices required (pacemaker, catheters, etc.).

Must have experience with Laser Welding.

Experience with MS Office and CAD software such as AutoCAD or Solidworks required.

Strong knowledge of FDA requirements as they relate to medical device manufacturing required.

Must have experience with establishing and supporting manufacturing processes (manual assembly, medical device packaging / labeling, resistance spot or laser welding or injection molding / extrusion).

Lean/Six Sigma Black Belt Certified desired.

Position is located in HOUSTON, TX and requires light travel.

Manufacturing Engineer, Medical Device
Southwest Florida

We are an established medical device company located in the Southwest Florida. We have an immediate need to hire a full time Manufacturing Engineer. The main responsibility of this position is to create, improve, develop, document and implement procedures required to assemble, process, test, manufacture medical device products.

Additional Responsibilities:

Increase production yields, decrease costs and refine a products design.

Create, improve, document, develop and implement procedures required to assemble, test, process, and manufacture our medical device products.

Increase production yields, decrease costs and refine a products design.

Contribute new ideas and find innovative methods to improve the efficiency of the manufacturing operation.

Develop and implement process control techniques and procedures into manufacturing environments.

Analyze manufacturing process flows continually for the enhancements of quality, cost reduction and throughput.

Design and develop manufacturing processes for enhancements, product changes and new products.

Provide engineering support in production department to trouble shoot and resolve technical problems.

Position Requires:

Bachelors Degree and a minimum of 5 years of recent medical device manufacturing experience.

Must be able to understand engineering drawings, product specifications, operating procedures and regulatory requirements as defined in ISO 13485.

Must have experience in writing and reviewing Engineering Change Orders.

Experience in designing manufacturing processes for process capabilities and repeatability.

Experience with Lean Manufacturing techniques, root cause analysis and cause and corrective action implementation.

Bi-lingual (English/Spanish) candidates strongly preferred.

Proficiency with Solidworks, MS Project, MS Access and ERP desired.

Senior Clinical Research Associate, Pharmaceutical
East Bay, California

We are a growing publicly traded clinical stage pharmaceutical company based in the East Bay. We have an immediate need to hire a Senior Clinical Research Associate (Sr. CRA). This is a full time permanent position based in the East Bay and requires up to 25% domestic and international travel.

In this key clinical research position the Sr. CRA will be responsible for the oversight of clinical trial protocol development to final report, regulatory filing / publications, coordinating cross functional efforts in the administration and progress of Phase I to IV 4 clinical trials.

Additional Responsibilities Include:

*Lead clinical trial start-up, conduct and close-out activities.

*Perform complex clinical project management and ensure that clinical trial timelines, costs and quality metrics are met.

*Establish study milestones and ensures accurate tracking and reporting of study metrics.

*Perform oversight of CROs and collaborations with other research entities.

*Provide input and manage clinical trial budgets and staffing/resourcing plans.

*Ensures clinical trial adherence to GCP/ FDA / ICH regulations.

Position Requires:

*Bachelors Degree with a minimum of five years of progressive pharmaceutical clinical trial experience.

*Must have experience leading clinical trials in a management or project management role.

*Prior Site Monitoring experience is required.

*Knowledge of FDA GCP and ICH guidelines required.

*Strong computer skills required.

*Therapeutic experience in infectious diseases and /or vaccines desired.

Must be willing to travel up to 25% with some overnights.

Web Application Developer

Full Time Virtual Position - Must Reside in California

We are a growing non for profit community health organization in Los Angeles, CA. We have an immediate need to hire a full time Web Application Developer with expertise in front end web development.  This position is a virtual job with meetings and some travel to customer sites required.

In this position you will be responsible for the design and development of effective and efficient Electronic Health Record (EHR) templates on presentation layer.  This is strictly a front-end web developer position writing layers that sit on top of NextGen EHR.

Additional Responsibilities:

*Use agile but structure development methods for the coding, testing and implementation of templates, reports and custom utilities.

*Design, construct, implement, and maintain EHR forms and reports as needed.

*Participate in the development and enforcement of policies, standards, and procedures for application support, report development, and practice builds.

*Develop and maintain documentation.

Position Requires:

*Bachelors Degree in Computer Science / MIS and a minimum of 3+ years of applications development experience with a focus on User Interface (UI) development using 4GL tools.

*Strong technical knowledge of Visual Basic (VB), Ruby on Rails and / or C# required.

*Must have experience with Agile development practices (SCRUM, JAD, and Evolutionary Development).

*Report development experience using Crystal Reports, SQL Server Reporting Services desirable.

Plastics / Tooling Engineer - Medical Device

Salt Lake City, Utah

We are an established medical device company located in Salt Lake City, UT. We have an immediate need to hire a full time Plastics / Tooling Engineer with expertise in plastic molding processes and tooling.

Job Responsibilities:

*Evaluate and analyze new part designs and determine the most cost effective method to produce the part and define the appropriate tooling and equipment requirements.

*Drive Design for Manufacturing (DFM) & Design for Assembly (DFA) while still in the Design phase.

*Analyze dimensional reports and provide direction to part designers and tool builders.

*Utilize analytical techniques to resolve conceptual issues.

*Work with Quality Assurance on dimensional layouts and resolving out of spec issues.

*Justify strategies and implement them effectively.

Position Requires:

*Bachelors Degree in Mechanical Engineering or Plastics and a minimum of 5+ years experience in medical device industry tooling engineering experience in a high-speed production environment.

*Knowledge of plastic molding processes and tooling.

*Must have knowledge of AQ-PQ and basic quality systems and processes.

*Experience with MS Office, SolidWorks.

*Six sigma experience and knowledge of plastic flow analysis (Mold Flow or SigmaSoft) is a plus.

*Two shot injection molding and medical device manufacturing experience desired.

This position is located in Salt Lake City, Utah. Relocation is available. 

Salt Lake City, Utah

We are an established medical device company located in Salt Lake City, UT. We have an immediate need to hire a full time Plastics / Tooling Engineer with expertise in plastic molding processes and tooling.

Job Responsibilities:

*Evaluate and analyze new part designs and determine the most cost effective method to produce the part and define the appropriate tooling and equipment requirements.

*Drive Design for Manufacturing (DFM) & Design for Assembly (DFA) while still in the Design phase.

*Analyze dimensional reports and provide direction to part designers and tool builders.

*Utilize analytical techniques to resolve conceptual issues.

*Work with Quality Assurance on dimensional layouts and resolving out of spec issues.

*Justify strategies and implement them effectively.

Position Requires:

*Bachelors Degree in Mechanical Engineering or Plastics and a minimum of 5+ years experience in medical device industry tooling engineering experience in a high-speed production environment.

*Knowledge of plastic molding processes and tooling.

*Must have knowledge of AQ-PQ and basic quality systems and processes.

*Experience with MS Office, SolidWorks.

*Six sigma experience and knowledge of plastic flow analysis (Mold Flow or SigmaSoft) is a plus.

*Two shot injection molding and medical device manufacturing experience desired.

This position is located in Salt Lake City, Utah. Relocation is available. 

Director, IT Application Architecture, External Service Delivery - US Midwest

This is an exciting opportunity within a major multi-national corporation charged with driving a global applications strategy focused on best in class applications rationalization and consolidation.  You will be responsible for developing, executing, and overseeing an external Service Delivery Model to implement and support an application framework.  You will be managing global IT projects and portfolios including new applications, legacy applications, and archived applications.  You will be a key team member of an Enterprise Architecture organization responsible for:

* Developing, executing, and overseeing a Service Delivery Model (SDM) to implement, maintain, and support a global application framework.
* Driving relationships with external Service Delivery partners and vendors.
* Leading a portfolio of companywide applications including SAP ERP (Enterprise Resource Planning), MRP (Manufacturing Resource Planning), Web Applications, Financial Management, Sales & Marketing, Research & Development, and Clinical applications.
* Leading companywide IT project management, portfolio management, applications management, legacy application management, capital planning, and strategic planning activities.
* Leading and developing global processes responsible for approving strategic global and local IT investments and IT resources.
* Developing strategic direction for application rationalization, demand management, and project performance management activities.
* Interacting with global IT leaders and leading global Program Management Office initiatives.
* Creating and facilitating processes to manage projects and providing a methodology to estimate required resources from within internal IT organizations.

Preferred Candidate Background and Expertise:

* 10+ years of industry experience managing and implementing global IT systems within a multi-national company.
* Successful experience driving and managing external relationships with Service Delivery Vendors providing outsource application management, development, maintenance, and support.
* Experience leading the companywide application architecture of applications including SAP ERP (Enterprise Resource Planning), MRP (Manufacturing Resource Planning), Web Applications, Financial Management, Sales & Marketing, Research & Development, and Clinical applications.
* Successful experience managing global IT projects and portfolios including new applications, legacy applications, and archived applications.
* Strong project management, portfolio management, and matrix management experience.
* BS or MS in Computer Science, Engineering, Business Administration, or related field. MBA preferred.
* PMP/PMI certification preferred.

* Please note - This is a full time position located within the Midwest but not in Chicago or Nashville - A full relocation package is provided for this position. *