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The Associate Director will manage and lead the Equipment Validation group within the Validation Technical Services Organization. The Associate Director is responsible for all activities associated with process equipment qualification, revalidation, computer qualification, SIP validation, and assisting with commissioning activities for the biopharmaceutical manufacturing facilty. Ensure qualification and validation activities meet internal and external compliance requirements. This position....


Hands-on technical leadership in design and execution of purification process development, optimization, scale-up, validation/characterization, process transfer activities, and GMP manufacturing support for early and late stage protein therapeutics. ? Strong understanding of technical processes, including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal.? Oversee and delegate experimental/project responsibilities,....

- North Chicago, IL

Stability Chemist North Chicago, IL Stability Chemist Position Summary The Stability Chemist will perform testing and packaging of stability samples in support of the stability program. The Stability Chemist will perform testing of raw materials and finished products in support of release of materials. Additionally, the Stability Chemist will support other activities associated with laboratory operation, and will review/enter data for compliance, review policy and procedure documents as....


DIRECTOR, R & D / Clinical- CONSULTANT - * Part-Time role which could evolve to full time *M.D. or Ph.D - M.D. preferredManage CRO'sWrite pre-clinical and clinical trial protocolsWrite Investigator Brochures - must be a strong writer, position will evolve into writing sections of regulatory documentsOncology experience / Gene Therapy ExperienceCandidate can work from home - candidates in greater Chicago area are preferred

- North Chicago, IL

Position Summary: As the Sr. Application Scientist, you will participate as a critical team member is ascertaining critical physical, analytical, and functional attributes of the Company’s present and future excipient portfolio. Search literature for bio-pharmaceutical formulation trends and develop collaborations to build Company’s formulation know-how and portfolio of solutions. Collaborate with our R&D and Sales and Marketing / Business Development team to develop and expand the....


We are working with a client in the Madison area in need of a Senior Quality Control Analyst. This client is a manufacturer of pharmaceutical ingredients. This position is for an experienced analyst with experience in qPCR and molecular technologies. This opportunity requires this person to be independent and a creative thinker. Responsibilities:Responsible for performing complex and routine laboratory analysis and testing of raw material, finished product and special products.All work is....

- San Diego, CA

Our client - a growing Pharmaceutical company in the San Diego area - is looking for an Analytical Chemist. The Chemist will perform analytical method development activities in support of Pharmaceutical drug products. Responsibilities will include:Development of analytical test methods Development of stability studies Performing literature searches Document/Record experimental activities in laboratory notebooks The Qualified Candidate will have analytical methods development experience in a....

- Western, MI

Company:Strong collegial group of people with a very strong team-minded cultureFast-paced work environment on highly technical projectsVery community-minded with a strong sense of giving back to the community with time and talents for charitable organizationsVery strong work-hard, play-hard mentality with fun events outside the officeCompany has grown nationally and this office is slated for growth as wellPrivately-held- you won't be a number hereNationally recognized for innovative,....


Top Tier Global Pharmaceutical Company in Cambridge, MA is expanding- competitive salary and bonus and amazing Long Term Incentives- Full relocation and benefits.. Associate Director, Clinical Quality Assurance – GI/CNS, Early Development More than 30,000 Company employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. As a global, research and development-driven pharmaceutical company, Company....

- St. Louis, MO

Our client - a major Pharmaceutical company in St. Louis - is looking for a Manager of Validation. The Manager will have overall responsibility for Validation in the following areas: Equipment Cleaning Packaging Process The Manager will be responsible for:Developing and implementing SOPs, Master Plans, Protocols for all of the above listed areas.Ensuring that all Plans and Protocols are compliant with both Company as well as External (i.e. FDA) requirements.Participating in Investigations and....


Leading Global Pharmaceutical Company is expanding and needs two different long term consultants for their Regulatory Team in Jersey City the first is a Regulatory Affairs Consultant in the CMC division and the second role is a Labeling Specialist They ALSO have additional Perm (FTE) roles if you are interested- please contact usReg Affairs Consultants: max pay rate is $40/hr Responsibilities: Support Regulatory Affairs CMC Manager in managing and maintaining regulatory documentation for....


Our Client is looking for a Director - Technical Operations. This position is an outstanding opportunity to join a rapidly growing Pharmaceutical Company. This role will have a high level of visibility and will interact with both internal groups within the Company as well as external vendors. The Director will be responsible for:Overseeing multiple projects involving the Tech Transfer and Scale-up of Injectable Dosage FormsCollaborating with internal resources and vendors for all technical....


The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Corporate Quality System in the areas of Clean Room, Sterilization and Environmental Controls and will serve as the expert on the knowledge of environmental and manufacturing clean rooms. The environmental and clean room SME must be able to apply ISO requirements across multiple manufacturing sites and divisions globally to include division / business support and quality expertise....

- Coram, NY

Our client, a rapidly expanding Pharmaceutical company located on Long Island, is looking for a QA Associate. The QA Associate will be responsible for a wide variety of responsibilities to include:Will be involved with document review, approval of protocols, approval of reports, lab investigations, batch record review, batch record release etc.Will work closely with & provide Quality support to R&D personnelWill assist in developing Quality SystemsWill assist in writing SOPs for....


The Automation Engineer reports to the Manager of the Automation group. The position is responsible for providing Automation Engineering support. Specific duties include:Working closely with multiple disciplines, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvementsProvide technical support to commercial and clinical manufacturing as needed, specific to process control and....


This role is for a physician capable of leading an ongoing program through product launch in the migraine space. Reporting to the Executive Director of Medical Affairs Neuroscience, this US Medical Lead will be responsible for providing strategic input and oversight on the development and life cycle management for a monoclonal antibody targeting a novel pathway for migraine currently in phase 3. This is the opportunity to join a growing Neuroscience Therapeutic Area that has commitment from....


Senior Microbiologist Manager To start a new Microbiology Laboratory with a national provider of specialty pharmacy. Opportunity to build a national program from the ground up that will support multiple facilities across the country producing aseptically-produced sterile compounds. Key responsibilities: Manage and oversee a team of direct reports.Assist with development of SOPs related to clean room controls and processes, assuring adherence to cGMPs, USP Standards, and company policies and....


Director of Quality Microbiology To build and run a new fully compliant QA department for a cGMP sterile 503B manufacturing facility. Key responsibilities:Implement and ensure compliance with US Food, Drug &Cosmetic Act, 21 CFR parts 210 and 211 Section 503A and 503B, and all its related elements such as facilities, documentation (SOPs and validation protocols, etc.), training, reports and recordsManage 503B facility chemistry and microlab for end product testing and environmental....


Top Tier global Pharmaceutical and Manufacturing company in Philadelphia is expanding and looking for a vivacious Customer Service Rep Great opportunity to get your foot in the door with Top company! 50k a year and benefits ($25/hour) send resume to hbr at clinicaldynamix dot com This position independently resolves complex, non-standard or high impact customer related issues. This is not a call center position; rather the scope of this position includes many of the following functions on a....


Senior Director/Executive Director, Clinical Research San Francisco Bay Area The primary responsibility is to provide medical guidance, medical review, analysis and data interpretation from clinical studies. This individual will act as the primary Medical Monitor and oversee the safety of clinical programs. In addition, provide scientific support to the Clinical Development team in the development of various oncology and hematology projects. Responsibilities: Acts as a medical resource to the....

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Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.