- Merck & Co. (Rahway, NJ)
- …to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for ... sterile development portfolio, and delivering on organizational unit priorities.-- The Director will be responsible for new product packaging development for vaccine… more
- Merck & Co. (Rahway, NJ)
- …process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory filings (IND, MAA, ... (FDA, EMA, JNDA, TGA).-Leadership:-Establish and manage Cell Banking working groups, support CMC teams, and align resources to deliver on priorities. Manage and… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory leader on ... senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and external consultants to… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based ... in Raritan, NJ. Role OverviewThe Director of Manufacturing Execution System (MES) will be part...will work collaboratively with Operations, IT QA, Validation, Reg CMC to deliver on-time, on-budget and right-first-time MES solutions… 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
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking a Director of CMC Quality for a direct hire opportunity with a leading biopharmaceutical company in South San ... onsite in South San Francisco, CA 3 days/week. **Position Title:** Director of CMC Quality **Position Type:** Direct hire **Salary:** $245,000-285,0000… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... radiopharmaceutical CMC development and manufacturing programs supporting various therapeutic areas within Lilly Avid. In this capacity, this role will drive the… more
- Boehringer Ingelheim (Athens, GA)
- …in close collaboration with Quality , R&D and Operations/Manufacturing. The Director , Scientific Expert CMC provides subject matter expertise in functional ... reflect Boehringer Ingelheim's high regard for our employees. The Director , Scientific Expert CMC is responsible for...goals. + Defines, plans, and oversees the development of high- quality CMC regulatory submissions, with a focus… more
- Lilly (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
- Lilly (Indianapolis, IN)
- …support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide strategic and ... operational leadership for cross-functional CMC team(s) and will partner with CMC ...competitive plans, anticipate risks, effectively communicate risks, enable high quality decisions at fast speed and implement decisions. +… more
- AbbVie (North Chicago, IL)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Pharma Product Group Associate Director will be fully accountable for providing CMC leadership and ... group. + Independently lead complex cross-functional PDS&T product teams. Represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located ... for leading all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that...sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- Danaher Corporation (Fargo, ND)
- …and improve human health. We are seeking a strategic and technically accomplished Director of Drug Product CMC to lead client-facing drug product development ... NDAs, IMPDs, etc.). + Coordinate cross-functional teams, including R&D, quality , regulatory, and clinical, to support CMC ...R&D, quality , regulatory, and clinical, to support CMC activities. The essential requirements of the job include:… more
- UTMB Health (Galveston, TX)
- Director of Operations, - CMC - Galveston County Jail **Galveston, Texas, United States** Business, Managerial & Finance UTMB Health Requisition # 2503778 The ... definition, and solution of systems problems through operations analysis and quality assessment. Reports to the Associate Vice President Outpatient Services,… more
- UTMB Health (Webster, TX)
- …care issues arising during care coordination processes and report issue/concern to the CMC Quality /Risk Management Department. + Collaborates with UTMB TDCJ Care ... care issues arising during infirmary placement and reports issue/concern to the CMC Quality /Risk Management Department. + Demonstrates strong problem solving… more
