- Takeda Pharmaceuticals (Boston, MA)
- …of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant ... based on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and… more
- Merck (Rahway, NJ)
- …your career. The Executive Director , Chemistry, Manufacturing & Controls ( CMC ), Pre-approval Pharm will bring scientific and regulatory expertise, innovative ... to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory...conjugates (ADCs), and traditional solid-oral small molecules. The Executive Director will help drive our company's growth into new… more
- Lilly (Indianapolis, IN)
- …all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in...with CMC team members. + Engage in site -specific regulatory activities to ensure maintaining registered… more
- Boehringer Ingelheim (Athens, GA)
- …with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from ... expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located ... for leading all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is seeking an experienced Associate Director or Senior Associate Director , Analytical to join the External Alternative CMC Development (EACD) team ... relevant external scientific bodies / consortia **Compensation Data** This position, Associate Director , External Alternative CMC Development (EACD) , offers a… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules (Associate Director ), you will be responsible for leading ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges, ... make a meaningful difference worldwide. Could you be our next Associate Director Global Regulatory Lead, EHT (Enabling Healthcare Technologies encompasses… more
- Bristol Myers Squibb (Devens, MA)
- …alongside some of the brightest minds in Biopharma. **Position Summary** The Senior Director , Head of Potency and Impurity Assay Development (PIAD) reports to the ... of subject matter experts to orchestrate and execute, within the network, CMC potency and impurity strategy and structure-function understanding of product quality… more
- Bristol Myers Squibb (Devens, MA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Site Quality Head, Goa Date:...technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep ... to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes...Practices **Location** This role is based on the Teva site in Goa, India. **How you'll spend your day**… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Associate Director , Supply Chain will lead and grow a supply chain team responsible for ... is a hybrid position requiring a minimum of three days per week on- site at the Philadelphia office. **Responsibilities:** + Ensure uninterrupted supply of critical… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly ... collaborative environment, partnering closely with Research, Analytics, CMC , Regulatory , Commercial Manufacturing, Quality, and external partners. In addition,… more
- Merck (Rahway, NJ)
- …control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + ** CMC RA** : Experience supporting/writing ... oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful… more
- Merck (West Point, PA)
- …(DoE) and statistical data analysis. + Experience in authoring and reviewing CMC regulatory documentation. + Financial acumen with experience in resource ... **Job Description** **Job Description: Director , Center of Excellence for Sterile Drug Product...+ Experience with implementing platforms and standard work in CMC commercialization, technical operations or manufacturing + Experience with… more
- Astrix Technology (Olmsted County, MN)
- …formulation processes for small molecules, peptides, and antibodies. + Manage CMC documentation to support regulatory submissions and clinical/commercial ... ** Director of Pharmaceutical Development** Clinical Olmsted county, MN,...including team management and mentorship. + Experience in preparing CMC documentation for regulatory submissions (eg, IND,… more
- Merck (West Point, PA)
- …BLAs.- The successful candidate will be responsible for strategic partnering with CMC development, Regulatory , Quality, and our partners in commercialization and ... and ensure safety and quality of our products. The Director of Vaccines Potency in Analytical Research & Development...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Director of Data & Digital Compliance and Governance will establish and ... role ensures governance is standardized, trusted, and embedded into Ops AI initiatives (Digital CMC , NEO, OMEGA and ALPHA), Factory of the Future, Lab/ QA of the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Sciences counterparts. + o Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision and strategy for manufacturing ... true to the best of my knowledge. **Job Description** **Title: Associate Director -Process Engineer SM API Process Sci** **Location: Cambridge, MA (Hybrid)** **About… more