- Catalent (PA)
- Account Director, Biologics Drug Substance Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative ... facility in Madison, WI. This position has responsibility for establishing new biologics drug substance partnerships in the target territory. Success will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance , Drug Product, or New Modality) Lead is ... the management of technology transfer of the manufacturing processes of (mAb, Drug Substance , Drug Product, or New Modality) for investigational and… more
- Merck & Co. (Durham, NC)
- …for the patients who need it. The facility will include end-to-end processing of drug substance , drug product, including biotech culture growth, harvest, ... the position includes all aspects of Quality oversight for drug product, drug substance , media...aspects of Quality oversight for drug product, drug substance , media preparation, and sterile supply.Position… more
- Merck & Co. (Rahway, NJ)
- …is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently ... plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance , drug product and packaging manufacturing sites of DS ... customer, DS affiliates and DS HQ's in order to ensure the quality of drug products marketed globally and acts as a global partner to successful drive QA… more
- Axelon Services Corporation (New Brunswick, NJ)
- …digital and modeling space. They will collaborate closely with partners within PD such as drug substance , drug product and analytical functions as well as ... with business partners such as IT. This role will report to the Sr Director, Product Development Strategy. Responsibilities -Collect and curate data from multiple sources including electronic notebooks, spreadsheets, slide decks, and instrument files -Ensure… 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 ... programs with a focus on methods to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate… more
- Merck & Co. (Durham, NC)
- …Quality Always.The Associate Director, Engineering/Maintenance will support a new drug substance manufacturing operation's engineering, maintenance, and ... areaResponsible for project management of operational readiness workstreams for new drug substance facility (ie maintenance master data, HECPs, SOPs)Responsible… more
- Merck & Co. (Rahway, NJ)
- …is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently ... plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial… more
- Aequor (Thousand Oaks, CA)
- …program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides ... completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to… more
- Aequor (Thousand Oaks, CA)
- …of analytical techniques used for protein molecule product quality control? Understanding of drug substance and drug product development and manufacturing? ... Strong leadership and management skills? General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals more
- Merck & Co. (Durham, NC)
- …This role will contribute to the performance and results of a E2E drug substance /product department and provide technical guidance. Off-shift and weekend ... and problem-solving skills.Preferred Experience and Skills:Demonstrated knowledge of MPS/LeanDrug Substance /Product commercial -experienceDemonstrated experience of interacting with site, divisional… more
- Sunrise System Inc (New Brunswick, NJ)
- …digital and modeling space. They will collaborate closely with partners within PD such as drug substance , drug product and analytical functions as well as ... with business partners such as IT. This role will report to the Sr Director, Product Development Strategy. Qualifications Bachelor's degree or higher in a relevant field such as chemical engineering, life sciences, data science, or computer science. At least 2… more
- Nesco Resource (Central Islip, NY)
- …relevant SOPs. Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product. Contributes to process improvement ... for providing Quality Assurance support for receiving/releasing GMP documentation of bulk drug substances and finished drug products Review documentation for… more
- Aequor (West Greenwich, RI)
- …provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate batch record and attachment reviews, ... industry. 2 Qualities of your ideal candidate? Has worked in similar drug manufacturing organization, within Quality for at least 2 years, Has Academic… more
- Merck & Co. (Durham, NC)
- …is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance . Focused areas of responsibility include but are not limited ... to activities of: Media Preparation, Fermentation, Tangential Flow Filtration, Process Monitoring, Sampling, and area cleaning. Responsibilities may include but are not limited to; Support operations production through start-up and commissioning and… more
- Aequor (Devers, TX)
- …Qualification and some project management experience Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical ... testing is highly desirable. Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5. Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper based batch records desirable.… more
- Aequor (Thousand Oaks, CA)
- …and be able to hold a technical conversation. Transferrable Industry backgrounds: Drug substance / pharma / chemical/ oil refinery/ mechanical This engineering ... position supports manufacturing activities associated with cGMP equipment and facilities at Thousand Oaks (ATO). The senior engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop… more
- Aequor (Devers, TX)
- …functions across the Devens campus. This may include Commercial and/or Clinical drug substance manufacturing, support of Site Engineering (Maintenance and ... Metrology activities), Supply Chain/Warehouse, Laboratories (Quality Control and Process Development), or Cell Therapy Manufacturing. Key contact for internal customers, researchers, facilities, management, and other cross functional groups, building strong… more
- Aequor (West Greenwich, RI)
- …8:00AM - 5:00PM. The Quality Control team provides analytical expertise in testing of drug substance and raw materials to meet specifications and ensure a ... constant supply of raw materials for products. more
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