- Gilead Sciences, Inc. (Foster City, CA)
- …production network. We are accountable for direct technical support of drug substance and drug product operations, with responsibility for all aspects ... Gilead and help create possible, together. **Job Description** **Senior Director, Biologics Drug Product MSAT** Gilead Sciences, Inc. is a research-based… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …responsible for the order processing and dispensing of raw materials, components, drug substance and drug product to Parenteral and Oral Solid Dose ... . Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product… more
- Lilly (Indianapolis, IN)
- …techniques to bring value across the portfolio. + Possess experience with drug substance and drug product Common Technology Document (CTD) authoring, NDA ... robust control strategies, enable clinical trials, regulatory submissions, and new product commercialization for our antibody- drug conjugate (ADC) portfolio.… more
- AbbVie (North Chicago, IL)
- …regulatory queries, and participates in Pre-Approval Inspections. + Critically evaluates and integrates drug substance , drug product , and device inputs ... Development will use their breadth of experience to drive best-in-class drug product development strategies in support of AbbVie's pipeline. This role will… more
- Aston Carter (Thousand Oaks, CA)
- …identifies internal and external risks that can lead to business disruption Drug Substance DS and Drug Product DP Network Strategy develops and ... Operations strategy for optimization of the commercial product supply network across drug - substance drug - product finished drug - product and… more
- Cambrex High Point (Charles City, IA)
- …is a leading global contract development and manufacturing organization (CDMO) that provides drug substance , drug product , and analytical services ... material testing, in-process testing, isolated intermediate testing, and finished good product release. + Work cross-functionally with other departments (such as… more
- AbbVie (North Chicago, IL)
- …queries, and participates in Pre-Approval Inspections as needed. + Critically evaluates and integrates drug substance , drug product , and device inputs to ... science, technology, quality, regulatory/compliance requirements, budget and resources. *Multiple product development experiences of leading a CMC team through IND… more
- Lilly (Indianapolis, IN)
- …leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. This will include, but not ... a depth of knowledge in concepts relevant to drug substance or drug product commercialization, including, for example, developing analytical methods,… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …will be tailoring the API material characteristics to balance both drug substance processability and drug product performance. The candidate is expected ... proteins is desirable. The individual will effectively interface and collaborate across drug substance , drug product and analytical development teams.… more
- Pfizer (Sanford, NC)
- …manufacturing process development. + Understanding of critical quality attributes of drug substance and drug product . + Experience in project management ... of Pfizer's dedicated and highly effective quality assurance and control team. The product lead in Quality Control (QC) Portfolio Management team is responsible for… more
- Fujifilm (College Station, TX)
- …CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture. **External US** **_Essential ... requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture. + Establish operational tier structure to… more
- Cambrex High Point (Longmont, CO)
- …is a leading global contract development and manufacturing organization (CDMO) that provides drug substance , drug product , and analytical services ... QC Release, Method development and validation experience with drug substance and drug product is preferred. + Excellent academic and professional record… more
- Merck (Durham, NC)
- …Carolina. This new facility will include end-to-end processing of both drug substance and drug product and quality control laboratories. The Associate ... technical support as part of one of the drug substance or drug product Technical Operations teams. **Position Responsibilities:** + Reporting to… more
- Fujifilm (Holly Springs, NC)
- …Data Coordinator 2 manages the master data processes to support both drug substance and drug product manufacturing. This role is responsible for the ... * Creates and maintains Master data setup for Raw materials, Drug Substance and Drug Product * Works cross functionally to acquire data * Participates in… more
- Pfizer (Andover, MA)
- …also performs micro method qualifications and Environmental Monitoring (EM) of Drug Substance and Drug Product facilities. The individual is responsible ... lab technique and facility gowning for EM in various GMP facilities (Cell Banking, Drug Substance , Drug Product ) as well as facility water collection &… more
- Belcan (Thousand Oaks, CA)
- …equipment/utilities/facilities -to- large/sophisticated capital projects to integrate new drug substance and drug product manufacturing technologies into ... control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance , Drug Product and Supply chain plant… more
- Sanofi Group (Cambridge, MA)
- …all aspects of synthetic/small molecule drug development, from candidate selection to product approval. This encompasses drug substance (DS), oral ... for applying cutting-edge process engineering principles across both drug substance (DS) & drug product (DP) design + You will drive the development… more
- OnKure, Inc. (Boulder, CO)
- …are seeking a highly motivated and experienced Director of Analytical Chemistry ( Drug Substance and Drug Product ) to join our PharmSci team. The ... Develop and execute the analytical CMC strategy for drug substance (DS) and drug product (DP) across preclinical and clinical stage assets Project… more
- Catalent Pharma Solutions (Bloomington, IN)
- …GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical ... proteins, new modalities, etc.), raw materials and consumables, technical writing, and drug substance lifecycle management. The MS&T organization supports the … more
- Amgen (Thousand Oaks, CA)
- …this program, you will work within the Manufacturing Clinical Supply Organization, Drug Substance or Drug Product Supply. Amgen invests in tools and ... agility and productivity of the organization through digitalization and automation. Within drug substance , the operational readiness team is responsible for… more