- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …to work effectively with CDMOs. The position reports to Executive Director , CMC & Product Development. **Job Description** **Pharmaceutical Development:** ... Director , Formulation Development is an experienced leader in...external functional representatives (CMOs, Manufacturing, Supply Chain, Quality Assurance, Regulatory , etc.) to deliver products that are commercially viable… more
- Takeda Pharmaceuticals (Boston, MA)
- …Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require ... as functional expert in divisional and cross-divisional initiatives. + Represents CMC on cross-divisional governance and development teams while providing strategy… more
- J&J Family of Companies (Malvern, PA)
- …best talent for Senior Director , Scientific Strategist** **Purpose:** The Senior Director will provide expert scientific and regulatory guidance across all ... **You will be responsible for:** + Developing and executing comprehensive CMC (Chemistry, Manufacturing, and Controls) technical and regulatory strategies… more
- Kelly Services (South San Francisco, CA)
- …management across our investigational and commercial portfolio. Reporting to the Senior Director of CMC , you'll be instrumental in overseeing API process ... Kelly(R) Science & Clinical is seeking an Associate Director / Director of Drug Substance Manufacturing for...scale-up, regulatory strategy, and operational excellence required for clinical and… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Executive Director , Formulation and Process Development** + The Executive Director ... + Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance… 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