- Merck & Co. (North Wales, PA)
- …products that improve human health and business.- -Under GPAM, the CMC Integrated Project Management (CIPM) organization supports Development and Commercialization ... Teams (DCTs) responsible for building and executing CMC development plans.--Under the guidance of the CIPM Staff..."oversight" is expected at this level. In addition, the Director may be expected to take on one of… more
- 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 ... 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
- 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 ... and communication skillsPreferred Experience and SkillsExperience in leadership of CMC development teams.Experience with cell culture process development for… 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 ...cross-functional CMC team(s) and will partner with CMC scientific and technical leaders with accountability for technical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… 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...Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority assets throughout clinical development. Key… more
- Lilly (Boulder, CO)
- …life better for people around the world. Eli Lilly and Company seeks a Director , CMC Pharmaceutics to work collaboratively to develop and deliver appropriate ... drug products for different phases of animal and human studies. Guide pre-formulation characterization and the design of formulations. Monitor the development of appropriate analytical testing methods for drug products. Manage the manufacture of drug products… more
- Actalent (Boston, MA)
- Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile regulatory professional eager to join a collaborative team as a ... Director /Sr. Director of Regulatory CMC based in Boston with a hybrid option. This role involves providing Regulatory CMC leadership for a dynamic… 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 Francisco, ... Hybrid, 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
- Boehringer Ingelheim (Athens, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Scientific Expert CMC is responsible for providing new product ... and priorities in close collaboration with Quality, R&D and Operations/Manufacturing. The Director , Scientific Expert CMC provides subject matter expertise in… 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 ... all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior...of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… 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
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of ... beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has… more
- UTMB Health (Galveston, TX)
- Director of Operations, - CMC - Galveston County Jail **Galveston, Texas, United States** Business, Managerial & Finance UTMB Health Requisition # 2503778 The ... time of offer. Standard office environment at UTMB's main campus or other CMC location. Security clearance is required; pre-employment drug testing is also required.… more
- AbbVie (North Chicago, IL)
- …third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality that are ... 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
- 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 ... is critical in driving the design, development, and execution of robust CMC strategies for a diverse portfolio of clients, spanning early-phase to commercial-stage… more
