- Merck & Co. (Durham, NC)
- …submission, PAI, and ultimately the commercial manufacture of the product's Drug Substance .-GENERAL PROFILE Provides leadership and direction to ensure ... that short and long term IPT objectives are achieved while reliably supplying quality product at a competitive cost and consistent with our company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal… 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)
- …in Durham, North Carolina. The new facility will include end-to-end processing of drug substance , drug product, including biotech culture growth, harvest, ... immediate business objectives even through adversity. This role will support drug substance manufacturing/sterile supply in regulated, clean room environments… more
- Novo Nordisk Inc. (Boulder, CO)
- …method development and transfer of methods for oligonucleotide intermediates (IPC's) as well as drug substance and drug product release within a nonGMP lab. ... Essential Functions Provide analytical support for nonGMP manufacturing of Oligonucleotides ( drug substance ) Conduct analytical method feasibility and transfers… more
- Merck & Co. (Rahway, NJ)
- …milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance , Drug Product, Analytical Development, and Clinical ... complex problems. Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical… more
- Insmed Incorporated (Bridgewater, NJ)
- …CROs/CDMOs associated with method development, qualification/validation, transfer and characterization for drug substance , drug product and reference ... degradation products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance .Prepares and approves… 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
- Merck & Co. (Rahway, NJ)
- …roles include the-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)
- …design, method development, optimization and transfer of immune- and cell-based assays for drug substance and drug product release, stability, and ... subject matter expertise related to potency assays for biologicals and new drug modalities.The qualified candidate will be responsible for program potency strategy,… more
- Catalent (PA)
- …develop the scope, pricing, and timeline of proposals for both new and ongoing drug substance programs and ensure scopes are adequately reviewed before being ... execution of the site visit.Assist with maintaining proposal templates and the drug substance price sheet, as appropriate.Collaborate with other Catalent… 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
- 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)
- …2 years of relevant experience. Required Experience and Skills: Experience with converting new drug substance process needs to an executable series of steps and ... regulations as it pertains to pharmaceutical development. Experience with small molecule drug substance and/or biologics process development and scale-up, moving… 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
- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us ... on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease! SUMMARY: Provide support for early and late-stage analytical development and characterization towards commercialization of monoclonal… 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
- Careerbuilder-US (Frederick, MD)
- …complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to ... support generation of CoAs for product release. * Maintains laboratory instruments for calibration and routine maintenance. * Author or revise SOPs, qualification/validation protocols and reports. * Asist with lab investigations regarding out of specifications… 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. As a Senior Technician you will be an energetic leader with strong interpersonal, communication, and collaboration skills… more
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