- Eisai, Inc (Exton, PA)
- …If this is your profile, we want to hear from you. Job Summary Oversee product release and stability testing at sites in the US and internationally. This position ... will be responsible for the review and interpretation of analytical testing data as well as protocols and reports,...overseeing assay validation and interacting with QA to determine product stability and shelf life. Since these programs are… more
- Merck & Co. (Rahway, NJ)
- …overall success of the pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the successful candidate will be an ... equipment. Support data rich experimentation at pilot scale via process analytical technologies (PAT) implementation in the SSO. Position Qualifications: Education… more
- Merck & Co. (Rahway, NJ)
- …healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product , Analytical Development, and Clinical Supply across all ... Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research… more
- Eisai, Inc (Nutley, NJ)
- …understanding of the cross-functional roles and responsibilities involved in drug development and product life-cycle management.Ability to travel ... verbal communication skills demonstrated by ability to present clear instruction/direction. Analytical and problem-solving capabilities.Strong scientific writing and presentation skills.IND123#LI-MG1Eisai… more
- Merck & Co. (North Wales, PA)
- …implementation.--Collaborate with Asset Development Teams, Early Development Teams; Product Development Teams, Clinical Trial Teams, Discovery, Informatics; ... include, but are not limited to the following:Work closely with Product Development Team and/or Early Development Team stakeholders.- Set protocol-level,… 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 ... for the management of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational… more
- Insmed Incorporated (Bridgewater, NJ)
- …on cGMP's, and familiar with other Regulatory Requirements applicable to a drug , medical device and combination product manufacturing and testing.Must perform ... New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part of the ... and investigations lead / owner for a best-in-class high volume marketed CAR-T product as part of a multi-site global manufacturing network. This individual is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …4 or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project ... meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Biostatistics is a highly visible role within the Clinical ... and is responsible for the statistical leadership and expertise for a product line through the entire development process. This role provides statistical input… more
- Merck & Co. (Rahway, NJ)
- …with respect to device component manufacture and final assembly of biologic/ drug product with device constituent part.Lead/support the development, ... years of leadership experience with deep working knowledge of device, biologic/ drug product , and process development including regulatory submission and… more
- Novo Nordisk Inc. (Boulder, CO)
- …External relationships include eg frequent interactions with NN vendors throughout the GMP drug substance and drug product manufacturing process as well ... in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. An Associate Director , ... options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We ... (PD) but are not limited to:Planning, preparing and reviewing pharmacometrics-related drug development plans and regulatory filings. This includes determining scope,… more
- AbbVie (North Chicago, IL)
- …developing analytical methods and providing analytical results to support drug substance and drug product process and formulation development. ... deliver high-quality drug products for patients. The Director , Biologics ARD will lead the Analytical ...various scientific disciplines needed in pharmaceutical development of biologics drug product ( analytical , manufacturing, QA,… more
- Lilly (Indianapolis, IN)
- …leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. This will include, but ... to drug substance or drug product commercialization, including, for example, developing analytical ...technical solutions and analytical strategies to enable drug substance process or drug product… more
- Curia (Hopkinton, MA)
- DIRECTOR ; ANALYTICAL DEVELOPMENT in HOPKINTON, MA...materials, drug substance and drug product . + Review and approval of relevant analytical ... and manufacturing services to the pharmaceutical and biotechnology industries. The Director , Analytical Development will provide technical leadership and lead… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Management - Biologics Quality Control (Grade 33)** **KEY RESPONSIBILITIES:** The Senior Director Analytical Lifecycle Management is vital for the success of ... for monitoring QC test method execution and leading the analytical lifecycle management of commercial biologics drug ...management of commercial biologics drug substances and drug products. The Senior Director collaborates with… more
- Lilly (Indianapolis, IN)
- …development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in building new platforms to ... **KEY OBJECTIVES/DELIVERABLES:** The responsibilities for this role will include: + Represent Drug Product team in CM&C teams and cross-functional interface… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and will operate at the interface of other closely related functions (QA, Regulatory, Analytical Science, Drug Product , Supply Chain etc.). Experience in ... **Description** The Associate Director of Drug Substance - EACD...lead on CMC teams and coordinate activities with regulatory, drug product , analytical and supply… more
