- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Pharmaceutical Manufacturing Investigator Department: Production Location: Monroe, NC START YOUR APPLICATION ... role in our company's growth by owning and investigating all Manufacturing -related deviations. The Deviation Investigator will collaborate with cross-functional… more
- Cambrex High Point (Longmont, CO)
- Company Information Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical ... in branded and generic markets for API and dosage form development and manufacturing . At Cambrex, our people set us apart. We're committed to attracting, nurturing,… more
- Kelly Services (Cincinnati, OH)
- …Qualifications, Skills, and Experience** _Minimum Requirements_ + Experience in Pharmaceutical Manufacturing and/or other similar regulated industry. + ... The Lead Investigator is responsible for performing investigations and driving...event to conclusion by working with others. The Lead Investigator ensures the investigation outcome and root cause analysis… more
- Actalent (Allendale, NJ)
- …full lifecycle of investigations, from initiation to closure, to ensure manufacturing and GMP compliance. Responsibilities + Determine the causes and preventative ... years of experience writing and reviewing deviations and investigations within a pharmaceutical company. + Experience working with quality assurance teams to ensure… more
- Bristol Myers Squibb (Summit, NJ)
- …in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with ... a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing ...investigations / CAPA development + Qualified as a deviation investigator and completes assigned investigations timely + Completes change… more
- Amgen (Holly Springs, NC)
- … investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication ... your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest… more
- Astellas Pharma (Northbrook, IL)
- …of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We ... relation to certain R&D legal transactions of the Research, Technology and Manufacturing (T&M), Development, Medical Affairs, and Rx+ functions. The position holder… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …critical technical resource in the QC Microbiology laboratory supporting the manufacturing of sterile injectable products. This position is responsible for ... This position is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry. This role is mainly responsible for completing deviation investigations,… more
- Merck (Honolulu, HI)
- …for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The Regional Medical Scientific Director serves ... Enhances the comprehension of the scientific foundations and goals of investigator -sponsored research + Identifies barriers to patient enrollment and retention… more
- ThermoFisher Scientific (St. Louis, MO)
- …Work:** Thermo Fisher Scientific Inc. is seeking a motivated and ambitious Deviation Investigator to join our world-class Manufacturing team in St. Louis. As ... Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** When… more
- ICON Clinical Research (Blue Bell, PA)
- …for working within established timelines of investigational product manufacturing , labeling, release, distribution and return/destruction, and/or helping to ... Management team, to ensure timely and compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or… more
- Organon & Co. (Plymouth Meeting, PA)
- …preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control (CMC), project management and other partner groups ... 2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, IND subsections, briefing books, submission modules, responses to… more
- Organon & Co. (Jersey City, NJ)
- …position serves an important role in the preparation of biowaiver requests for manufacturing site changes or active pharmaceutical ingredient or excipient supply ... modules for regulatory submissions, contribute the authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as… more
- Lilly (Indianapolis, IN)
- …in all systems under his/her responsibility, understanding their applications in pharmaceutical manufacturing , understanding flow charts and process parameters, ... to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research… more
- Sun Pharmaceuticals, Inc (Los Angeles, CA)
- Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 ... billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by...updated on new data + Respond to requests for investigator sponsored research (ISS) proposals and transit them into… more
- Astrix Technology (Springfield, MO)
- …and executing quality investigations, including deviations and OOS events, within Manufacturing and QC departments. This role ensures compliance with internal ... (CAPAs). **Key Responsibilities** + Perform and document Deviation Investigations for Manufacturing and Quality Control operations. + Conduct Root Cause Analyses… more
- Takeda Pharmaceuticals (Boston, MA)
- …Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety ... as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing , and Legal. + Interact with Regulatory Authorities as part… more
- Merck (Albany, NY)
- …OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its customers to ensure compliance with all external and ... Engagement, Decision Making, Diversity and Inclusion (D&I), Healthcare Education, Investigator -Initiated Studies (IIS), Medical Affairs, Medical Marketing Strategy, Microsoft… more
- Charles River Laboratories (Ashland, OH)
- …ensure scientific integrity of studies.Independently function as a Principal Investigator , Individual Scientist, or Project Scientist asassigned. + Write, review, ... 12 years related experience in the contract research, academic, or pharmaceutical industry. + Practical laboratory experience conducting ELISAs and multiplex assays… more
- BeOne Medicines (San Mateo, CA)
- …in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing , QC, QA, etc.). + ... the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project. + Provide comments on new… more