- Merck & Co. (Rahway, NJ)
- …problems, support pilot plant operations, and interface with cross-functional colleagues/customers in drug substance , drug product, and material science. ... drug product processing and experience collaborating across the drug substance / drug product interface.Experience with crystallization Process… more
- Merck & Co. (Rahway, NJ)
- …facility start-up and knowledge transfer.Candidates with significant experience in engineering design ( Drug Substance , Drug Product, Plant and Clean ... quality workExperience representing Engineering Design interests on Project Teams for drug substance and drug product Small Molecule projects for… more
- Aequor (Bothell, WA)
- …material, receiving, inspection, storage, transferring and issuing inventory of materials, drug substance in intermediates, governed by SOP's.The Inventory ... product and samples with external contract sites.Principal Responsibilities: Ship GMP bulk drug substance , intermediates and QC samples with IATA/DOT 19 CFR… more
- Merck & Co. (Rahway, NJ)
- …roles include development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw ... or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development.Ph.D. in chemistry or related science… more
- Merck & Co. (Rahway, NJ)
- …and application of current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, ... eg in a pilot and/or factory settingCurrent Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true… more
- Merck & Co. (Rahway, NJ)
- …depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, robust and productive ... research/process development including performing unit operations common in small molecule drug substance process development such as chemical reactions,… more
- Aequor (Waltham, MA)
- …of drug development, from molecule/pre-candidate to product approval. This encompasses drug substance (DS), drug product (DP) and analytical development, ... to NDA approval. Our mission is to serve patients through innovation in drug development and by designing state of the art manufacturing processes.About the job:GMU… more
- Merck & Co. (Rahway, NJ)
- …small molecule product development, commercialization, and supply, including comprehensive knowledge of drug substance (DS), drug product (DP), device, ... that aligns with enterprise goals. Ensure the successful transition of drug product candidates from development to commercialization to supply.- Talent Development:… more
- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us ... opportunity to gain hands-on experience in analytical development to support drug development from early to late-stage clinical programs.ESSENTIAL FUNCTIONS: Assist… more
- Merck & Co. (Rahway, NJ)
- …will be joining a group of innovative scientists with a focus on drug substance (API) analytical deliverables to drive lead-time reduction and efficiency ... techniques (eg, chromatography, and spectroscopy) and product specification to support drug substance development and registration.Have a fundamental knowledge… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation ... reviews and/or operations.Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale down establishment, computational… more
- Merck & Co. (Rahway, NJ)
- …methods and specifications for drug products as well as drug substance downstream formulation considerationsThe candidate should have experience in ... In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position… more
- Novo Nordisk Inc. (Boulder, CO)
- …on drug development and manufacturing Strong background in oligonucleotide-based drug substance development and manufacturing including knowledge of nucleic ... acid synthesis, purification, ultrafiltration, annealing and lyophilization techniques and equipment is highly desired Experience in the transfer and scale-up of development processes to the manufacturing scale Experience with new plant startup and operations… more
- Merck & Co. (Rahway, NJ)
- …process characterization and GMP manufacturing (including cell banks, virus seeds and drug substance ) in close collaboration with our company's external ... partners. The candidate will be expected to effectively communicate with stakeholders in external and internal partner organizations and lead cross functional teams. Collaborate with external partners to provide capabilities and capacity to support our company… more
- Merck & Co. (Durham, NC)
- …is a leadership opportunity within the Engineering/Maintenance team supporting a new drug substance manufacturing operation.- The individual in this role must ... provide direction, coaching, and technical expertise to maintenance and instrumentation technicians assigned to start up and maintain the new facility (process, utility and automation assets). This individual must actively manage his/her team to reliably… more
- Aequor (Devers, TX)
- …review of raw materials, in-process, batch release, and/or stability samples of Bulk Drug Substance in a cGMP compliant environment. Performs routine inventory ... and sample management of routine samples, critical reagents and non-routine samples. Main responsibilities include Chain of Custody. Executes routine procedures owned by the Sample Management functional area. Assignments are made in the LMS, by the hiring… more
- Aequor (West Greenwich, RI)
- …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 Following: Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations. Ensure that facilities, equipment,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation ... Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization… more
- Merck & Co. (Rahway, NJ)
- …organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We ... work closely with colleagues in Discovery, Pre-clinical and Early Development to rapidly develop manufacturing processes for diverse biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process… more
- Merck & Co. (Durham, NC)
- …to B160 Operations areas (sterile supply, weigh/dispense, media, stabilizer/prep, Drug substance , filling, capping/inspection, clean utilities etc.) located ... in aseptic and clean room environments.- Works within a team to perform maintenance and troubleshooting activities.- Completes complex maintenance tasks, resolves deviations and evaluates equipment performance.- Follows proper procedures for maintaining… more
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