- Lilly (Lebanon, IN)
- …Serve as the primary site interface for global supply chain, procurement, manufacturing, process development , and quality teams for direct material readiness. + ... + Build functional capability in handling diverse modalities (small molecule, biologics , and peptides) and fast-paced development timelines. _Clinical Material… more
- Charles River Laboratories (Rockville, MD)
- …75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, ... deviations. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing… more
- Otsuka America Pharmaceutical Inc. (Frankfort, KY)
- …relevant experience in the biopharmaceutical industry with a strong focus on biologics downstream process development , scale-up, technology transfer, and/or ... **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership...Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory, Process Development , Analytical Development , and… more
- Fujifilm (Holly Springs, NC)
- …expense reports etc.) + Coaches and guides direct reports to foster professional development + Participates in the recruitment process and retention strategies ... **Position Overview** The Director , Engineering Science plays a pivotal role in...implemented effectively. This role is crucial in enhancing site's process equipment and technology capability offerings and maintaining competitiveness,… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Director , Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) activities for a large-scale ... biologics manufacturing facility in compliance with regulatory requirements, including...This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment… more
- Catalent Pharma Solutions (Morrisville, NC)
- ** Director , Business Development , Nasal Delivery** **Position Summary** Catalent is a global leader in providing integrated services, superior delivery ... to join our growing team. Reporting to the Vice President of Business Development , Inhalation, the Director , Business Development - Nasal Delivery… more
- AbbVie (North Chicago, IL)
- …Responsibilities + Author and coordinate submission documentation for all phases of clinical development of biologics , with emphasis on later phase programs and ... responses to questions from regulatory authorities. + Leverage extensive biologics drug development experience to lead the...CMC regulatory documents in collaboration with CMC Regulatory and Process R&D. + Partner with CMC Regulatory to assist… more
- Charles River Laboratories (Wayne, PA)
- …75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, ... Identify the need for Corporate Quality and Compliance Policies and lead development and implementation efforts. ⦁ Direct site/operation Quality Assurance program to… more
- Bristol Myers Squibb (Devens, MA)
- …Level Process Engineer** with deep experience in cell therapy or biologics to support process lifecycle management and enable scalable, compliant, and ... Hours **Responsibilities:** + Develop tools for automated processing of: + Process Performance Qualification (PPQ) protocols/reports + Continued Process … more
- Lilly (San Diego, CA)
- …are seeking an exceptional physician scientist to join our Immunology team as Medical Director , Early Clinical Development . This role is designed for a clinical ... critical gap between discovery science and clinical application, driving the development of transformational medicines for patients with autoimmune and inflammatory… more