- Programmable Medicine Operatin (Redwood City, CA)
- …Author and review technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to review master batch records ... Substance and Drug Product. The successful candidate will be required to work on site 5 days per week. We are focused on developing novel nanomedicines, HD… more
- 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
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted:… 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 (New Brunswick, NJ)
- …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
- 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
