- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Eisai, Inc (Exton, PA)
- …as well as with 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. (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...guidances, and is-responsible for the preparation and submission of CMC dossiers for all assigned development products. -Primary responsibilities… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives for… 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 ) ... and regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products,… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... and packaging activities as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical supply chain metrics and/or… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… 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 ... Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external… more
- Organon (Plymouth Meeting, PA)
- Job Description The Position The Principal Scientist ( Director ) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects ... internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial product… more
- Bristol-Myers Squibb Company (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. Summary The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance ... develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in… 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 ... and communication skillsPreferred Experience and SkillsExperience in leadership of CMC development teams.Experience with cell culture process development for… 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
- John Muir Health (Concord, CA)
- Job Description: The Executive Director Surgical Services will provide highly visible leadership of the Surgical Services at Walnut Creek Medical Center or Concord ... Medical Center workforce and foster a culture which values and demonstrates clinical excellence, staff empowerment and continuing professional development of clinical staff within Surgical Services. Responsible for the delivery of patient care that promotes… more
- nChroma Bio (Boston, MA)
- …medicines. ABOUT THE ROLE nChroma Bio is seeking a Senior Director , Analytical Development/Quality Control to drive the strategic development and execution ... related to QC. The candidate's ability to represent the AD/QC function in Regulatory CMC meetings and drafting the Module 3/IB documents is a must. Candidate should… more
- Cedent (Cambridge, MA)
- …including strategy development, global submissions, agency meetings, and expedited designations; CMC experience is a plus. Experience in ophthalmology is an ... advantage. Project management experience is beneficial. Strong oral and written communication skills. Comprehensive understanding of global pharmaceutical development, including clinical and nonclinical activities. Department: Direct Clients This is a full… more
- EPM Scientific (Rockville, MD)
- …years of experience in biopharmaceutical process development, MSAT, or CMC roles. Extensive experience with commercial-scale cleaning validation and contamination ... control. Including ability to lead contamination control and cleaning validation programs. Proven expertise in large-scale stainless steel bioprocesses. Experience supporting DS manufacturing and cross-functional technical problem-solving. Must have biologics… more
- Vaxcyte (San Carlos, CA)
- …equality and clarity across communications and decision making. Summary: The Director , Process Validation and Risk Management has the accountability for: Commercial ... and regulatory risks within the end-to-end manufacturing processes In this role the Director will be a part of the Global MSAT organization reporting to the… more
- General Proximity (San Francisco, CA)
- …chemistry, cell biology, pharmacology, DMPK, safety assessment, and CMC Preclinical PK/PD/efficacy relationships and their clinical translation Collaborating ... with regulatory, CMC , and clinical groups to develop strategic regulatory paths...of PROTAC/molecular glue/next-gen IPMs Working knowledge and participation in CMC activities Benefits Strong equity incentives. We are looking… 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
- Neurocrine Biosciences, Inc. (San Diego, CA)
- …Facebook. (*in collaboration with AbbVie) About the Role: The Executive Medical Director will be primarily responsible for developing and executing the Neurology ... (including clinical operations, preclinical/clinical pharmacology, biometrics, regulatory, drug safety, CMC ). Responsible for medical oversight of clinical research studies,… more
