- 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
- BeOne Medicines (Emeryville, CA)
- …our growing in-house IP legal team to serve as a leader of our Biologics IP team and support BeOne Medicines R&D, business development, and commercialization efforts ... - Lead an IP team in the US and China primarily focused on biologics portfolio to build and maintain a strong intellectual property portfolio to support the… more
- Merck & Co. (Upper Gwynedd, PA)
- …will take our leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way ... we approach serious diseases. --The Senior Director will report to an Associate Vice President in...Group. Under the guidance of a supervisor, the Senior Director has primary responsibility for the planning and directing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development ... (SMAR&D) GxP Operations team has an opening for a Director based in Rahway, NJ. The primary objective of the SMAR&D GxP Operations team is to carry out analytical… more
- Merck & Co. (Rahway, NJ)
- …Description: Our Research and Development Division's microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations.- The primary objective of ... oversee GMP environmental monitoring and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of… more
- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics , and ... experience (GMP, GCP, and/or GLP) in a regulated environment supporting biologics , drug products, or combination products.Deep knowledge of phase-appropriate quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs QA is ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director … more
- Formation Bio (New York, NY)
- …intelligence to break clinical development paradigms and transform how drugs and biologics are developed. We are acquiring and developing a portfolio of ... include management of other attorneys.Essential Experience: Deep expertise in pharma/ biologics IP lifecycle management, from early development through commercialization… more
- Merck & Co. (Rahway, NJ)
- …external partnerships that grow our portfolio in meaningful ways. - The Director , Business Development & Licensing - Enabling Technologies Search and Evaluation, ... Technologies team supports areas that include Discovery Chemistry, Discovery Biologics , Vaccines, Pharmacology, Quantitative Biosciences, Companion Diagnostic/Diagnostic, and Developmental… 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 ... Experience and Skills: Experience with small molecule drug substance and/or biologics process development and scale-up, moving from laboratory to pilot scale.… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing the ... in responding to inquiries from HAs. (EMA & FDA) Extensive experience with biologics and/or small molecule Formation Bio is prioritizing hiring in key hubs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... priorities at one time required and- Knowledge of ADC or other biologics , or small molecules Demonstrated experience working with an alliance partner company… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval ... understanding of US, EU, and Japanese regulations for human drugs/ biologics .Knowledge of global regulatory guidance documents and regulations with emphasis… more
- Curia (Boston, MA)
- DIRECTOR , ANALYTICAL DEVELOPMENT in Hopkinton, MA Build your future at Curia, where our work has the power to save lives Curia is a global contract development and ... therapies from curiosity to cure and ultimately to improve patients' lives. The Director , Analytical Development will provide technical leadership and lead a team of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple priorities at one time required- Knowledge of ADC or other biologics , or small molecules preferred- Demonstrated experience working with an alliance partner ... company preferred Travel: Ability to travel up to 20% 20-25% travelDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual… more
- Insmed Incorporated (NJ)
- …a leadership position.Deep understanding of US, EU, and Japan regulations for drugs/ biologics with the ability to identify the differences in regulations across the ... regions. Proven track record of close collaboration with Regulatory Agencies as the lead in agency interactions and product development meetings.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Endo International (Horsham, PA)
- …we serve live their best life. **Job Description Summary** The Associate Director , Manufacturing Operations will provide leadership and management of operations at ... including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership team and works… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of ... relevant dissolution data. The scope includes small molecules and biologics /biosimilars, simple and complex formulations within Organon's general medicines portfolio… more
- Programmable Medicine Operatin (Redwood City, CA)
- …Engineering, Biotechnology, or life sciences 9+ years of small molecules or Biologics development and manufacturing experience of injectables and oral dosage forms ... participation in the annual bonus program. At the Associate Director level, the salary range for this position is...is $160,000 - $185,000 annually. The range for a Director is $185,000 $243,000. We consider various factors when… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory strategies ... regulatory, and registration strategies within the US and Canada. The Director will also provide line management, people development, and performance management… more
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