- Merck & Co. (Rahway, NJ)
- …Development Division's microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations.- The primary objective of the position is to oversee ... GMP environmental monitoring and microbiological release of pipeline products.-...release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose… more
- Insmed Incorporated (NJ)
- …Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP ... Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and...GMP requirements and ensuring alignment with global Quality strategy. Lead and develop a team of 2-8 Quality professionals… more
- BioAgilytix (Durham, NC)
- …Cytometry, ELISA, qPCR, ddPCR, USP CompendialsPrepare plate mapsServe as lead analyst on sample analysis projectsTroubleshoot assaysCompile/process data (make power ... export)Prepare summary tablesPeer review raw dataOrder reagentsParticipate in assay development and validationAdhere to provided method/directivePrepare buffersUse LIMS systemParticipate in sample analysisPipettingAdhere to safety requirements Keep accurate… more
- Coty (Sanford, NC)
- …todrive high-impact capital projects, leveraging advanced automation, hygienic design, and GMP standards. Lead innovation in beauty manufacturing with ... for capacity expansion, cost optimization, and safety enhancement. You will lead cross-functional engineering initiatives to deliver impactful capital projects that… more
- BeOne Medicines (Pennington, NJ)
- …operations. + Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures. + Lead troubleshooting efforts for ... with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological… more
- Endo International (Rochester, MI)
- …development and new product/process/technical transfer activities associated with employee operations, GMP Compliance and safety. + Lead initiatives for root ... information required for the job_ _e.g. knowledge of FDA regulations, GMP /GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Microsoft Office Suite, Quality Management… more
- Merck & Co. (Durham, NC)
- …12.5 hour (6:30 PM-6:30AM) rotation (2-2-3). - The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with ... expertise working in aseptic production and manufacturing operations. -The Lead Technician is a manager developmental role and will serve on the Operations… more
- BeOne Medicines (Pennington, NJ)
- …to day operations of the Biochemistry laboratory. **Essential Functions of the job:** + Lead the QC Biochemistry GMP laboratory through late phase activities. + ... Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished… more
- Post Holdings Inc. (Battle Creek, MI)
- …and safe working condition while meeting all regulatory requirements. - Perform safety, GMP , and pre-operational audits. - Lead and drive continuous improvement ... food safety and quality practices as required through SQF and GMP 's. **Qualifications** **Leadership Competencies:** Organizing, planning, drive for results, action… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe ... Quality Systems Lead role is an exempt level position with responsibilities...support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready ... background. **Job Description** **Job Summary** We are looking for a seasoned Lead Associate, Quality Audits professional who will conduct assessment on company… more
- Merck & Co. (Rahway, NJ)
- …Operations, is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, release, and maintenance in ... inspections of facilities or operations in supported areas, including GMP Certification inspection. Education Minimum Requirement:- BS in appropriate Science… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the...support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations,… more
- Curia (Rensselaer, NY)
- …and the preparation of CAPAs and monitor the completion of assigned tasks. + Lead and drive the GMP activities, work with manufacturing Managers and supervisors ... + Manage all the customer audits at the site, lead the preparation of CAPAs, and monitor their completion...regulations (eg, 21 CFR 11, 210, 211, 820, EU GMP , ICH Q7), Quality Systems for active pharmaceutical ingredients… more
- WuXi AppTec (Middletown, DE)
- **Overview** The QC Microbiology Lead will manage all microbiology laboratory activities at WuXi STA's drug product manufacturing site in Middletown, DE. This role ... is responsible for establishing, maintaining, and continuously improving GMP -compliant microbiological testing programs for drug product manufacturing, including… more
- Post Holdings Inc. (Britt, IA)
- …- Adhere to all safety policies and procedures. - Detect and correct GMP /Safety violations. - Act upon employee issues. - Adhere to safe work practices, ... follow GMP 's & SQF policies, maintain sanitary conditions and ensure...EXPERIENCE REQUIRED: Education: No prior experience or training. Experience: Lead experience preferred. Language Skills: Ability to read and… more
- WuXi AppTec (Middletown, DE)
- **Overview** The QC Analytical Lead is responsible for establishing and managing all analytical operations for the QC function at WuXi STA's new drug product ... transfers from global R&D and client facilities, and the implementation of GMP -compliant systems for testing drug products, raw materials, and components. The QC… more
- ValSource, Inc. (Worcester, MA)
- …technically skilled leaders in Process/Process Equipment Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network ... our clients’ Process Engineering programs within Pharmaceutical and Biotech GMP manufacturing facilities. This includes systems and equipment used...to act in the best interest of the client. Lead the project through an offsite design effort (at… more
- Kerry (Blue Earth, MN)
- …and grow in a truly global environment. About the role The Production Lead is responsible for promoting safety awareness, producing high quality product, while ... Ensures that products are made in sanitary conditions and GMP practices are being followed. ? Assign GMP...vacations and personal time as well as covering additional lead tasks. ? Document and collect all daily production… more
