- Fusion Pharmaceuticals (Chelsea, MA)
- …for Fusion's growing pipeline of RCs. Fusion Pharmaceutical is opening a role for a CMC Project Leader . Reporting to the Vice President of Manufacturing, ... this individual will be responsible for leading CMC efforts for our lead asset, FPI-2265...The successful candidate will bring a strong background in CMC and Project leadership. This position is… more
- Merck & Co. (Rahway, NJ)
- … leader is-accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... will be responsible for advancing the company's biologics portfolio.Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the… more
- Aequor (Thousand Oaks, CA)
- …and education to expanding current job responsibilities. is searching for a Sr. Project Manager in our CMC Integration team within Operation Products Advancement ... product, and device expertise Nice to have tools: Planisware, MS Project , Smartsheet discovers, develops and delivers innovative human therapeutics. A biotechnology… more
- Merck & Co. (Rahway, NJ)
- …to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director, Lead of Strategy for Device Product Assessment & Innovation will define and build ... decision-making strategy for all elements of early development. They will lead various early development and innovation initiatives to support continuous improvement… more
- Merck & Co. (Rahway, NJ)
- …reputation through conference participation.Represent BPR&D as a upstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise, ... medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur team in Rahway, New Jersey, is seeking an experienced leader who will manage a team of scientists to support drug substance process development ... The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in...recruiting, appraising, and developing personnel under her/his/their supervision. The leader will maintain a strong network internally and will… more
- Merck & Co. (North Wales, PA)
- …Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically ... Author and review technical documents. Complete assigned work within established project timelines. Ensure adherence to GMP standards and facilitate ongoing… more
- Insmed Incorporated (NJ)
- …and Clinical Operations timelinesFoster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and ... and external partnersServe as clinical supply representative on cross-functional project and clinical strategy teams; translate protocol design into demand/supply… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities for our cell and gene ... ability to work cross-functionally in a fast-paced biotech environmentKey Responsibilities Lead and oversee all toxicology strategy and execution for preclinical… more
- Organon & Co. (Plymouth Meeting, PA)
- …regulations and?guidance, and?Organon procedures.? The Associate Principal Scientist will lead the?preparation and submission of CMC dossiers?for life-cycle ... but are not limited to:? **Responsibilities** + Serve as the? CMC Product Lead ?for assigned products and be?accountable...Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of … more
- Organon & Co. (Plymouth Meeting, PA)
- …science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project management and other partner groups as part ... **Job Description** **The** **Position** The Director, Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES end users to define change ... Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC , and IT. This individual will support the MES...reliably gauge task effort and plan work to meet project timelinesWork closely with the MES and MSAT organization… more
- CSL Behring (King Of Prussia, PA)
- …- In-depth knowledge in the drug development processes for pharmaceuticals (eg project management, CMC , non-clinical, clinical, Regulatory Affairs). - Experience ... innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building...week. You will hold work closely with the CDT Lead and other Clinical Representatives in performing delegated tasks… more
- WuXi AppTec (Natick, MA)
- …Technical Marketing Specialist- CMC (San Diego, CA) - Analyze pharmaceutical project and technical requirements for CMC projects for business development; ... and conferences, applying knowledge of chemical engineering, biochemistry, pharmaceutical project management, Chemistry, Manufacturing, and Controls ( CMC )… more
- Organon & Co. (Jersey City, NJ)
- …regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle ... are not limited to: **Responsibilities** + Serve as the CMC Product Lead for assigned products and...Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of … more
- CSL Behring (King Of Prussia, PA)
- …is accelerating innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building a future-ready team ... Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate...(eg, GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk… more
- Parexel (Trenton, NJ)
- **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... love to connect. We are seeking a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will… more
- Organon & Co. (Plymouth Meeting, PA)
- …teams (ADTs). This position will report to the Non-Clinical Safety Assessment Lead . The NCD team is comprised of non-clinical drug development scientists ... regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development. Non-Clinical Safety Assessment… more
- Arup (Los Angeles, CA)
- …edge systems that will meet challenges in decarbonization and resiliency. Our aim is to lead our clients into a sustainable future but we will deliver this in an ... the delivery of coordinated and code-compliant designs. + Participate in project meetings and coordinate with architects, engineers, and consultants. + Prepare… more
- BeOne Medicines (San Mateo, CA)
- …across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and Regulatory Technology teams. While Regulatory Operations ... risks and support leadership decision-making. **Audit & Inspection Support** + Lead planning, preparation, and execution of internal audits and mock inspections.… more
