- WuXi Biologics Group (Los Angeles, CA)
- A leading biologics technology company is seeking a Director for CMC Management to oversee IND enabling and late-stage product development. This role ... in a relevant field and over 8 years of experience in CMC activities. Responsibilities include establishing strategies, leading project efforts, and collaborating… more
- WuXi Biologics Group (Los Angeles, CA)
- Job Title - Director - Executive Director CMC Management Work Location - West Coast (Preferably San Diego, Los Angeles, San Francisco, Seattle) WuXi ... CMC activities. Participate and show leadership in establishing WuXi Biologics CMC strategies and recommendations in supporting all ongoing projects… more
- Gilead Sciences, Inc. (Foster City, CA)
- Director in Biologics Analytical Development (Pivotal and Commercial) Director in Biologics Analytical Development (Pivotal and Commercial) United States ... Gilead and help create possible, together. Job Description The Director in Biologics Analytical Development (Pivotal and...testing strategies Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with… more
- Gilead Sciences, Inc. (Foster City, CA)
- Senior Director - Biologics Analytical Development (Pivotal and Commercial) United States - California - Foster City Process/Product Development & Operations ... fulfil their aspirations. Join Gilead and help create possible, together. Senior Director in Biologics Analytical Development (Pivotal and Commercial) Foster… more
- Blonde Inc. (Boston, MA)
- …with global health authorities. The Director will work cross-functionally across CMC , Quality, Clinical, and Program Leadership teams and will play a ... Hemab is seeking a Director of Regulatory Affairs, CMC to...and registration strategies. This role requires deep expertise in biologics CMC regulatory requirements and the ability… more
- Exelixis, Inc. (Alameda, CA)
- …while adhering to change control procedures and health authority requirements.* Monitor Biologics CMC regulations and guidance to assess relevant changes and ... CMC Regulatory Dossier Mgmt Director page...job):**This role provides PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects. Responsible and… more
- Taiho Oncology in (Princeton, NJ)
- …Value Proposition: Join our dynamic and expanding mid‑size company in the role of Director for Regulatory CMC directly reporting to Executive Director , ... CMC . Your expertise will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and post approval projects in US,… more
- Gilead Sciences, Inc. (Foster City, CA)
- Director , Manufacturability Assessment, PDM Biologics United States - California - Foster City Process/Product Development & Operations Regular Job Description ... Join Gilead and help create possible, together. Job Description The Director , Manufacturability Assessment (Pre-Pivotal) will be responsible for interfacing with the… more
- Vertex Pharmaceuticals (Boston, MA)
- …leader to join our Analytical Development Team to lead Biologic project CMC analytical development activities. The experienced leader will play a central role ... in advancing our biologics projects by executing development activities through a combined...a member of dynamic and diverse Analytical Development and CMC teams focused on science and innovation, this position… more
- Dyne Tx (Waltham, MA)
- …and follow us on X, LinkedIn and Facebook. Role Summary The Associate Director , Regulatory Chemistry Manufacturing and Control ( CMC ) is accountable for executing ... Act as point of contact to cross-functional teams on global Regulatory CMC project/ program issues Execute regulatory policies and operational processes to… more
