- Merck & Co. (Rahway, NJ)
- …analytical techniques (eg, chromatography, and spectroscopy) and product specification to support drug substance development and registration.Have a fundamental ... will be joining a group of innovative scientists with a focus on drug substance (API) analytical deliverables to drive lead-time reduction and efficiency gains in … more
- Merck & Co. (Rahway, NJ)
- …cross-functional interactions is essentialStrength in delivering results on firm deadlines in support of drug substance and product development and commercial ... development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, and… more
- Merck & Co. (Rahway, NJ)
- …breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, robust and productive processes, ... laboratory bench and kilo lab scales, in addition to support of and scale-up to pilot plant and commercial...including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and… more
- Merck & Co. (Rahway, NJ)
- …part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) ... provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for… more
- Merck & Co. (Rahway, NJ)
- …selection, vendor interaction/management, factory acceptance testing, technology transfer support , construction support , equipment qualification, facility ... knowledge transfer.Candidates with significant experience in engineering design (Drug Substance , Drug Product, Plant and Clean utilities), product equipment… more
- AUROBINDO (Durham, NC)
- …history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization have given Aurolife a jump start ... equipment. Familiar with OOS/OOT investigations, laboratory safety, and controlled substance handling. Possesses strong technical writing, documentation, and de-formulation… more
- Merck & Co. (Rahway, NJ)
- …clearly, and with confidence as they discuss technical problems, support pilot plant operations, and interface with cross-functional colleagues/customers in ... drug substance , drug product, and material science. Mentoring chemistry and...drug product processing and experience collaborating across the drug substance / drug product interface.Experience with crystallization Process Analytical… more
- Merck & Co. (Durham, NC)
- …leadership opportunity within the Engineering/Maintenance team supporting a new drug substance manufacturing operation.- The individual in this role must provide ... This individual must actively manage his/her team to reliably support customer demand (including employee development, routine coaching sessions, recognition,… more
- Aequor (Waltham, MA)
- …drug development, from molecule/pre-candidate to product approval. This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical ... manufacturing, and support of global regulatory filings from IND submission to...processes.About the job:GMU CMC Operation role will provides holistic support into the operational needs of the CMC organization… more
- Novo Nordisk Inc. (Boulder, CO)
- …Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, ... of the job duties, the senior manager should seek to actively support continuous improvement initiatives and identify wherever possible improvements that will reduce… more
- Merck & Co. (North Wales, PA)
- …part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) ... provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for… more
- Lundbeck (Bothell, WA)
- …new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to ... opportunity to gain hands-on experience in analytical development to support drug development from early to late-stage clinical programs.ESSENTIAL FUNCTIONS:… more
- Merck & Co. (Rahway, NJ)
- …across the lifecycle of product franchises, (2) project and portfolio management support across pipeline and supply, and (3) the development and advancement of ... emerging regulatory expectations, and enterprise leadership of technical priorities in support of the value chain.Horizon analyses of emerging technologies to… more
- Merck & Co. (Rahway, NJ)
- …candidate will be responsible for coordination of outsourcing to support development and manufacturing programs, including biologics and vaccines.The ... and GMP manufacturing (including cell banks, virus seeds and drug substance ) in close collaboration with our company's external partners. The candidate… more
- Merck & Co. (Rahway, NJ)
- …processes through process characterization, tech transfer, validation, filing and supply support . -The incumbent is expected to provide scientific expertise in small ... plant or factory scaleDesire to perform both laboratory experimentation and on-site support of scale-up activities and manufacturing operationsAbility to work in the… more
- Merck & Co. (Durham, NC)
- …Technician is responsible for providing equipment troubleshooting and maintenance support to B160 Operations areas (sterile supply, weigh/dispense, media, ... stabilizer/prep, Drug substance , filling, capping/inspection, clean utilities etc.) located in aseptic...significant interaction with Production, Technical Operations, Quality and other support groups. This position will be for second shift… more
- Aequor (West Greenwich, RI)
- …be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities. This position requires working directly with Manufacturing ... staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. Responsibilities Include the… more
- Merck & Co. (Rahway, NJ)
- …sterile products for injectable, ophthalmic, and inhaled routes of administration. Support both early and late-stage development candidates that will include ... methods and specifications for drug products as well as drug substance downstream formulation considerationsThe candidate should have experience in developing… more
- Merck & Co. (Rahway, NJ)
- …our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work closely ... Scientists and Engineers to design and develop downstream purification processes in support of early and late-stage biological products.-- The scope and activities… more
- Teva Pharmaceuticals (West Chester, PA)
- …you'll spend your day** * Gain in-depth insight into the CMC Downstream Drug Substance Development department * Support the development of the biologics pipeline ... Intern - R&D, Downstream Drug Substance Development Date: Jan 17, 2025 Location: West...opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All… more
