- 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...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… 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
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… 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 ... The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… 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 ... post-market commercial manufacturing biologics. For commercial programs, activities include site -to- site process transfers, manufacturing investigations and trend… 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
- EPM Scientific (Rockville, MD)
- …robust, agile strategies for cleaning validation and contamination control across the site . This role will lead the continuous improvement initiatives of the ... related to microbial contamination. Key Responsibilities: Develop and maintain site -wide cleaning validation and contamination control strategies aligned with… more
- CSL Plasma (King Of Prussia, PA)
- …and continuous improvement across CROs, consultants, lab service providers, and CMC vendors Functional Business Operations Leadership Provide strategic direction and ... internal teams and external partners, aligned with portfolio demands CMC Vendor Oversight (REDC): Provide governance, coordination, and performance...goals. Please take the time to review our benefits site to see what's available to you as a… 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
- Xaira Therapeutics (Brisbane, CA)
- …About the Role We are seeking a highly skilled and proactive Associate Director , Research Project Manager to oversee the planning and execution of biologics projects ... filing. Deep understanding of biologics R&D processes, including nonclinical, CMC , and regulatory components. Strong analytical, planning, and organizational skills;… more
- Alumis (South San Francisco, CA)
- …goal is to fundamentally change the outcomes for these patients. The Senior Director of Clinical Operations is a pivotal role within our organization, responsible ... and industry best practices. Lead responses to audits as required, including site , internal file and process, and regulatory agency audits. Develop and execute… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management ... on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on...alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global… more
- Lilly (Indianapolis, IN)
- …strategies impacting product submissions across geographies and networks for alignment with CMC team members. + Engage in site -specific regulatory activities to ... the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new...who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs -… more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis.… more
- AbbVie (North Chicago, IL)
- …high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching...level. Qualifications *This position will be required to sit on- site 3 days / week* Qualifications: + Bachelor's Degree… more
- UTMB Health (Brazoria, TX)
- Mental Health Clinician - CMC - Clemens **Brazoria, Texas, United States** **New** Social Service UTMB Health Requisition # 2503824 The mission of Correctional ... Works under the supervision of a Psychologist, Mental Health Manager and/or Program Director . **_ESSENTIAL JOB FUNCTIONS_** **:** + Contributes to the success of the… more
- Atlantic Health System (Pompton Plains, NJ)
- Under the direction of the Laboratory Director , the Manager, Laboratory Operations will coordinate and oversee a wide variety of administrative, personnel and ... thinking in Laboratory Management is important. This role acts as the on- site administrative resource for the laboratory team + Performs ongoing departmental… more
- Atlantic Health System (Pompton Plains, NJ)
- …into collection tube or bag. 5. Withdraws needle, applies treatment to puncture site , and labels and stores blood container for subsequent processing. 7. Conducts ... all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted:… more
- Atlantic Health System (Pompton Plains, NJ)
- …all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted: ... & Academic Advising + Parental, Adoption, Surrogacy Leave + Backup and On- Site Childcare + Well-Being Rewards + Employee Assistance Program (EAP) + Fertility… more
