- Amgen (Thousand Oaks, CA)
- …lives of patients while transforming your career. Process Development Senior Scientist - Pivotal Biologics Drug Substance Technology What you will do Let's ... Development organization at Amgen develops, characterizes and supports the commercialization of biologics drug substance manufacturing processes for all… more
- Genentech (Oceanside, CA)
- …with a strong emphasis on safety, compliance, reliability, and cost-effectiveness in drug substance , drug product and respective process analytical ... related discipline. 15+ years of experience in the bio-pharmaceutical industry, ie biologics manufacturing, development or related CMC functions, with at least… more
- Otsuka America Pharmaceutical Inc. (Oklahoma City, OK)
- …and commercial product quality to ensure global supply for Otsuka's patients. Job Description Provides Biologics QA support for Drug Substance and Drug ... The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by… more
- Lilly (Indianapolis, IN)
- …0-5 years of experience in the pharmaceutical or biotech industry in developing Drug substance (small molecule or biologics ) manufacturing process ... a strategic commitment to the growth of novel modalities such as Antibody- Drug Conjugates (ADCs) and Antibody-Oligonucleotide / siRNA conjugates (AOCs), and an… more
- Merck & Co. (Rahway, NJ)
- …our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely ... launch new products.This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art...a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ.… more
- Merck & Co. (Rahway, NJ)
- …our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely ... new products. This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art...a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ.… more
- Catalent Pharma Solutions (Kansas City, MO)
- …services for stand-alone and integrated biologics projects. Eg analytical support for drug substance , drug product, and intermediates for both innovator ... Kansas City facility is home to our Clinical Delivery Services and Biologics Analytical Services businesses. The site provides a range of integrated services… more
- AbbVie (North Chicago, IL)
- …and execution of Biologics and/or Toxin industrialization programs with experience in drug substance and/or drug product transfers. The program manager ... strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC technical development and pharmaceutical regulations Must have demonstrated… more
- AbbVie (South San Francisco, CA)
- …dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. The CMC Biologics Drug Substance organization is a team of ... solutions. They are responsible for all Chemistry, Manufacturing, and Control ( CMC ) cell line and bioprocess development activities for AbbVie's early-stage and… more
- AbbVie (South San Francisco, CA)
- …(https://www.tiktok.com/@abbvie) . Job Description Sr. Scientist I Cell/Molecular Biology The Development Sciences Biologics CMC Drug Substance Cell Line ... design principles to optimize RNA expression levels and assembly of multi-chain biologics . + Design experiments and perform genetic characterization of CHO cell… more
- Amgen (Thousand Oaks, CA)
- …of patients while transforming your career. **Process Development Senior Scientist - Pivotal Biologics Drug Substance Technology** **What you will do** Let's ... Development organization at Amgen develops, characterizes and supports the commercialization of biologics drug substance manufacturing processes for all… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of experience in pharmaceutical or biopharmaceutical development/manufacturing, with substantial exposure to biologics Drug Substance and Drug Product. ... Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative biologics in a...upside for the company. You will own the end‑to‑end CMC lifecycle for both Drug Substance… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product. + Proven track record in ... and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …development products. This role provides subject matter expertise for all aspects of Drug Substance (API), Drug Product, and Combination/Device product ... **Overview** The Director, CMC provides leadership for the Chemistry, Manufacturing and...by Design (QbD) and Design Control activities related to drug substance , drug product, and… more
- Taiho Oncology (Princeton, NJ)
- …and contractors. + Ensures that the pharmaceutical development, manufacturing and testing of drug substance and drug product conforms to current global ... related to pharmaceutical development, manufacturing, or quality. + Fifteen years' previous CMC drug development and regulatory experience (both US and EU\… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …commercial product quality to ensure global supply for Otsuka's patients. **Job Description** + Provides Biologics QA support for Drug Substance and Drug ... The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Pharmaceutical Development and Manufacturing organization (PDM). Experience in leading the Manufacture of Biologics Drug Substance is a must. This role ... experience in a pharmaceutical/biotech organization + Experienced in sterile large-molecule drug substance or large-molecule drug product manufacturing… more
- AbbVie (South San Francisco, CA)
- …organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. The Biologics Drug Substance organization is a world-class team of ... solutions, but are also responsible for all Chemistry, Manufacturing, and Control ( CMC ) cell line and bioprocess development activities related to the development of… more
- Takeda Pharmaceuticals (Lexington, MA)
- … CMC content for multi-site products. You will ensure that complex, multi-site biologics drug substance processes are robust, well-controlled, and aligned ... global expansions/contractions, and regulatory activities. + Ensure technical continuity of biologics drug substance manufacturing processes over time… more
- Lilly (Indianapolis, IN)
- …to develop robust chemical processes that are readily amenable to efficient drug substance manufacturing. + Design experimental laboratory plans in support ... units. **Position Summary:** The current position focuses on small-molecule drug -linker synthetic chemistry. The current opportunity is within the Bioproduct… more
