- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us ... Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization....Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019,… 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
- 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
- Genentech (South San Francisco, 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. (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)
- …Development and Manufacturing organization (PDM). + Experience in leading the Manufacture of Biologics Drug Substance is a must. This role requires ... 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
- 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
- Catalent Pharma Solutions (Kansas City, MO)
- …services for stand-alone and integrated biologics projects. We provide support for drug substance , drug product, and intermediates for both innovator and ... City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical...Matter Expert, as required + Responsible for the controlled substance programs at KCM to include holding Power of… more
- Amgen (Holly Springs, NC)
- …while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility ... Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry...plant goals + Support regulatory filing, inspection, and other CMC activities **What we expect of you** We are… more
- Lilly (Indianapolis, IN)
- …antibody- drug conjugates (ADCs), with a focus on linker-payload intermediate and/or conjugated drug substance / drug product. In this role, you will lead ... and validate analytical methods for ADC linker-payload components and/or conjugated drug substance / drug product; establish specifications, characterize… more
- Lilly (Indianapolis, IN)
- …Responsibilities:** + Possesses prior experience leading analytical efforts focused on pharmaceutical drug substance and/or drug product development and ... and validate analytical methods for ADC linker-payload components and/or conjugated drug substance / drug product; establish specifications, characterize… more
- Gilead Sciences, Inc. (Foster City, CA)
- …propose and justify analytical control strategies, author relevant regulatory filings for biologic drug substance and drug product. + Lead the development ... + Advanced expertise and hands-on experience with LC-MS based biologics characterization and data analysis to support CMC...ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.… more
- Takeda Pharmaceuticals (Boston, MA)
- …and downstream), process technology transfer and support of clinical manufacturing of drug substance (DS) using mammalian cell or related expressions systems. ... understanding of the global regulatory environment and evolving expectations relation to CMC , process development, and manufacturing of biologics . + Demonstrated… more
- Merck (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
