- Merck & Co. (Rahway, NJ)
- …GMP activities supporting the production of clinical supplies with focus on drug product . Additionally, experience in medical device and/or combination products ... Bachelor's degree in relevant area.Experience:Minimum of 5 years within pharmaceutical drug product manufacturing and 10 years overall within… more
- Catalent (Manassas, VA)
- Associate Director , Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry ... consumer and Catalent employee. The primary duty of the Associate Director , Regulatory Affairs is to support..., Regulatory Affairs is to support regulatory strategy for product development and manufacturing activities for the Cell &… 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, ... experienceLeadership experience with deep working knowledge of device and/or biologic/ drug product and process development including regulatory submission… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/Lead as part of the ... / owner for a best-in-class high volume marketed CAR-T product as part of a multi-site global manufacturing network....uniformed service member or veteran status, or any other characteristic protected by law. Legend Biotech maintains a drug -free… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of ... the Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… 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 ... management of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... and management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to ... and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... BLA Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, ... materials management, weigh and dispense, GMP manufacture, formulation development, and bulk Drug Product release.- Close connectivity with upstream Drug … more
- Aequor (Newbury Park, CA)
- …and Business Partner representatives in the development and maintenance of regional drug product labeling; manages labeling commitments for Business Partners as ... requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …efforts, and pre-launch planning for pipeline assets. Relationships Reports to Associate Director / Director , Strategic Market Insights. Supports current ... to unstructured problems with minimal guidance. This position will mainly support New Product Planning and pipeline assets and responsibilities will cover a mix of… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:RoleAs a member of the Product Strategy team at Fidelity Digital Assets\u2120, you will be focused on both defining the product strategy and the ... the digital assets ecosystem. Building those products will require owning the product roadmap, interpreting market needs and working with development and design… more
- Fidelity TalentSource LLC (Merrimack, NH)
- …or a closely related field and six (6) years of experience as a Director , Product Management (or a closely related occupation) implementing and maintaining risk ... field and four (4) years of experience as a Director , Product Management (or a closely related...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
- Fidelity TalentSource LLC (Westlake, TX)
- Job Description:The Role As Director , Network Product Management, you will be working in a team responsible for managing products and vendors through the entire ... product lifecycle from strategic planning in support of the...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
- Fidelity TalentSource LLC (Westlake, TX)
- Job Description:The RoleThe Director , FFIO Global Product Solutions (GPS) is responsible for coordinating and leading cross business unit operational activities ... managementTransferable skills include risk management, compliance, and project managementThe TeamThe Director , FFIO Global Product Solutions will join a team… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The RoleThe Director of Product Disclosure Policy and Regulatory Strategy is responsible for establishing and administering guidelines for the ... portfolio holdings information across Fidelity s retail and institutional product lines and will also play an integral role...focused on emerging regulatory matters impacting our business. The Director will:Be the primary day to day contact for… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description: Director , Product Management The RoleThis role will lead product development within one of the Fidelity Center for Applied Technology (FCAT) ... new product and technology incubators, focused on scalable strategies, experiments,...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
