- Merck & Co. (Upper Gwynedd, PA)
- …, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is responsible ... CMC - Associate Principal Scientist, CMC...pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance, n ovel modality and technologies such as… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ( CMC ) ... in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and execute… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and...The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in… more
- Eisai, Inc (Exton, PA)
- …Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Eli Lilly and Company (Indianapolis, IN)
- …better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who ... need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs -... Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC… more
- ACROBiosystems Inc. (Boston, MA)
- …target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion ... diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to… more
- Pharmaron (Waltham, MA)
- Position: Business Development Manager / Director , DP&C (Discovery, Preclinical & CMC ) - Boston FLSA Status: Exempt Location: Waltham, MA (Hybrid) Salary: ... are actively searching for an innovative and motivated Business Development Manager / Director , DP&C (Discovery, Preclinical & CMC ). This role involves managing… more
- UTMB Health (Dickinson, TX)
- …under the supervision of a Psychologist, Mental Health Manager and/or Program Director . ESSENTIAL JOB FUNCTIONS: Contributes to the success of the UTMB Correctional ... mental health, medical and other staff. Assists in the implementation of Quality Improvement/ Quality Management (QI/QM) programs and the monitoring of compliance… more
- Vera Therapeutics (Brisbane, CA)
- …Translational Medicine, Clinical Pharmacology, Bioanalysis, Chemistry Manufacturing and Controls ( CMC ), Quality Assurance, Regulatory, and Project Management, ... Job Description Title: Executive Director , Translational Research Biology Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage… more
- Takeda Pharmaceutical Company Limited (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
- Bristol-Myers Squibb Company (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary Director of Validation, Cell Therapy Technical Operations reports to the ... Senior Director , Cell Therapy Technical Operations within the Cell Therapy...deploy global cell therapy validation technical standards via the quality system. Promote innovative and efficient approaches to validation,… more
- Barrington James (Madison, OH)
- Senior Medical Director , Clinical Development (Oncology) Location: US Remote A global, innovation-driven biopharmaceutical company is seeking a Senior Medical ... Director of Clinical Development to support the advancement of...and late-stage assets, this company is committed to developing high- quality and accessible biologics for patients worldwide. Position Overview:… more
- Shriners Children's (Spokane, WA)
- …in order to best utilize available care management resources in providing quality patient care. Participants in a multidisciplinary approach to care and provides ... Human Resources policies and procedures and in consultation with Director . Assures each staff member undergoes an annual performance...WA 3 years experience in nursing Case Management Certification ( CMC , ACM or ANCC), if not currently certified -… more
- Clinical Management Consultants (Riverdale, NJ)
- …Manager Labor & Delivery. With its Magnet recognition and high rankings in hospital quality and care for adults and children, this institution has earned its place ... The RN Manager Labor & Delivery will report directly to the Director Labor & Delivery. Key responsibilities include overseeing nursing care, ensuring compliance,… more
- Bristol Myers Squibb (Indianapolis, IN)
- …radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops and drives Quality ... the following. Other duties may be assigned. + Member of CMC Development Teams providing Quality (QA) input from pre-clinical to end of product life cycle… more
- AbbVie (Irvine, CA)
- …AST and obtains resources from functional areas. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan ... Further develop your expertise and join our team as Director , CMC Product Development. Must have Medical...experience required to effectively manage global teams and all CMC activities with respect to science, technology, quality… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... Communicates regulatory decisions and strategy to stakeholders in development, manufacturing, and quality + Ensures that global CMC regulatory commitments are… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …innovative CMC regulatory strategies and the preparation and submission of high‑ quality CMC sections of INDs, CTAs, and original marketing applications ... Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics...+ Directs and oversees the preparation and review of high- quality CMC related regulatory submissions and leads… more
