- Merck & Co. (Rahway, NJ)
- …with cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- …late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics ... external presentations and publications.Minimum required education: Ph.D. in Biochemistry, Biologics Sciences, Chemical Engineering, or related field with 10+ years… more
- Eisai, Inc (Exton, PA)
- …If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and ... Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) ... regulatory compliance, and play a key role in scaling our biologics capabilities in partnership with technical, quality, and regulatory leaders.Responsibilities… more
- Merck & Co. (Rahway, NJ)
- …Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose ... in development.The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 10-15 direct reports composed of experienced,… more
- Merck & Co. (Rahway, NJ)
- …of regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in ... expertise in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a ... the forefront of innovation in the-Manufacturing Division, specifically within the- Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification-department… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …Better Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced analytical ... drive the implementation of evolving scientific technologies to support late-stage biologics programs. With a deep focus on separation-based techniques (eg, U/HPLC,… more
- Merck & Co. (South San Francisco, CA)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...work on the discovery and development of small molecules, biologics and non-traditional therapeutics like peptides, novel biological constructs,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...progressive leadership roles in a cGMP operation, with prior Biologics and/or cell therapy operations experience preferred.Prior experience leading… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Biochemistry, Biological Sciences, Biologics License Application (BLA), Electronic Common Technical Document (eCTD),… more
- Merck & Co. (Boston, MA)
- …decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of ... pharmacometricians.The Director -Pharmacometrics will work with scientists within QP2 by proactively...understanding of global regulatory expectations for small molecules and biologics and authoring regulatory documents (INDs, CSRs, CTDs) Required… more
- Merck & Co. (San Francisco, CA)
- …decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate ... Director will work with scientists within QP2 by applying...understanding of global regulatory expectations for small molecules and biologics , authoring regulatory documents (INDs, CSRs, CTDs), and representing… more
- Genmab (NJ)
- …have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be based in our Princeton,… more
- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics , vaccine) Drug Product development and Good Manufacturing Practice (GMP) ... Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct… more
- Merck & Co. (Rahway, NJ)
- …scientific methodology, we collaborate to discover the next medical breakthrough.The Biologics Analytical Research & Development department of our Company's Research ... scientific role tasked with working closely with the group Director to define group strategy and to lead a...chemistry, and lab informatics disciplines to enable development of biologics pipeline.We are looking for a team player with… more
- Omni Inclusive (Devens, MA)
- Reporting to the Executive Director of Downstream PD Network and Director of Biologics Bioassay CoE , this individual will be responsible for general ... administrative support to the local Biologics Development employees (approximately ~100 staff) in Devens, MA....functional area head o Provide back up support to cross- Biologics Development assistants Site Based Responsibilities o Support on-site… more
- Travere Therapeutics (San Diego, CA)
- …elevating science and service for rare patients. Position Summary: The Director , Technical Operations - Drug Product - Late Phase/Commercialization, is responsible ... drug product manufacturing, scale up, validation, and commercialization of a biologics product. The successful candidate enjoys managing external CDMOs and… more
- Accede Solutions, Inc. (Lexington, MA)
- Hybrid Role The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This ... a CMC focus At least 3 years Regulatory CMC biopharmaceutical experience, biologics experience required Proven ability to manage projects. Capable of performing… more
