- Merck & Co. (Rahway, NJ)
- …combination products , with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a ... Job DescriptionThe Associate Director - Device Tech Transfer is...technology transfer, problem-solving and working collaboratively with receiving sites, drug product partners, and Technical Product… more
- Merck & Co. (Rahway, NJ)
- … products , as well as combination product stewardship for inline products . The Executive Director will lead multiple functions in the department of ... across technical transfer initiatives, working collaboratively with the Senior Director , Directors, and Associate Directors, and cross-functional teams.Utilize… more
- Eisai, Inc (Exton, PA)
- …difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading ... well as supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role within ... for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other devices to enhance the value of our oncology pharmaceutical products .Responsibilities: CDx development : Provide critical strategic and tactical regulatory ... and support timely registration of both therapeutic and diagnostic products in the EU as well as UK and...(Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into… more
- Genmab (NJ)
- …to building extra[not]ordinary(R) futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines(R) that change ... complex matrix environment. Strong understanding of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input to multiple aspects of the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... is also accountable to promote a quality culture within across the product portfolio by providing governance support, quality oversight of strategic initiatives in… more
- Merck & Co. (Durham, NC)
- …policies, procedures and business plan; receives guidance and oversight from Operations Associate Director and Director ;Interprets client and/or customer ... contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance....and any action plans to address gaps to the Associate Director and/or Director .- Identify,… more
- Merck & Co. (Durham, NC)
- …to meet immediate business objectives even through adversity. This role will support drug product in regulated, clean room environments complying with current ... management and ultimately shop floor leadership.- Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line… more
- Eisai, Inc (Pittsburgh, PA)
- …with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and ... is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic products within an assigned territory in a compliant and appropriate manner.… more
- Lilly (Pleasant Prairie, WI)
- …growing Global Manufacturing Procurement Capital & Infrastructure team. As the Associate Director - Drug Products Capital Procurement, you will play a ... strategies to design, construct and qualify new Lilly manufacturing facilities for the Drug Products network of site in the Midwest The role will lead sourcing… more
- Rhythm Pharmaceuticals (Boston, MA)
- …highly motivated individual to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small molecule ... Responsibilities and Duties + Ensures development and validation of all drug product processes meets regulatory requirements including FDA, EU, ICH requirements… more
- Merck (West Point, PA)
- …combination products , with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a ... **Job Description** The Associate Director - Device Tech Transfer is...technology transfer, problem-solving and working collaboratively with receiving sites, drug product partners, and Technical Product… more
- United Therapeutics (Research Triangle Park, NC)
- …with a PhD/PharmD + For Clinical Drug Development Associate Director level: + 10+ years of product development experience with hands-on experience ... preclinical studies to ensure the successful submission and approval of a drug product by regulatory agencies. This role will provide scientific insight into… more
- Sumitomo Pharma (Nashville, TN)
- …Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, and ... neurology, and cell & gene therapies. With several marketed products in the US, Canada, and Europe, and a...and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism.… more
- IQVIA (Durham, NC)
- …get treatments to the right patients, faster. **Job Overview:** The Channel Management ( Associate ) Director will play a critical role in supporting the ... Regulatory Affairs and Drug Development Solutions (RADDS) team-not through direct sales, but...due diligence, asset valuation, gap analyses, indication prioritization, target product profiles, clinical development plans, study design and synopsis… more
- Catalent Pharma Solutions (Greenville, NC)
- …fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Associate Director , Commercial Quality Assurance ... ** Associate Director , Commercial Quality Assurance** **Position...Lead the team-based approach for review and verification of drug product quality in manufacturing, packaging and… more
