- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Director , CMC provides leadership for the Chemistry, Manufacturing and Controls ( CMC ) function for Xeris' commercial and clinical/late-stage ... translates into skillful and competent application of knowledge to ensure the CMC function is in alignment with the Company's corporate and departmental goals.… 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
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) ... apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables. This individual prepares CMC… more
- Sumitomo Pharma (Springfield, IL)
- …dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part ... strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs… more
- AbbVie (North Chicago, IL)
- …automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, work with ... . Provide guidance, technical advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support to laboratory… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... ensure compliance with applicable regulations and guidelines. + Provide CMC functional representation on wider cross-functional program development teams, ensuring… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Director of Data & Digital Compliance and Governance will establish and ... role ensures governance is standardized, trusted, and embedded into Ops AI initiatives (Digital CMC , NEO, OMEGA and ALPHA), Factory of the Future, Lab/ QA of the… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Director , Programs & Alliances will be responsible for program and alliance management of Xeris's development partnerships and programs ensuring ... specifically for pharmaceutical development projects with a concentration in CMC activities OR similar experience within CMC ,...in CMC activities OR similar experience within CMC , R&D, Quality, or Regulatory. * Demonstrated knowledge of… more
- Merck (Springfield, IL)
- …product lifecycle management for drug-device combination products. Reporting to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director , ... governance into the border our Company governance structures (ex. DCRC, LDRC, CMC -wide). + Establish key performance indicators (KPIs) to measure progress towards… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- **Senior Director , Early Development Team Lead** **Role Summary:** The Early Development Team (EDT) Lead is a critical role - working to deliver Otsuka's pipeline ... knowledge of all functional areas of exploratory development, including, CMC (small molecules and biologics), biology, toxicology, clinical pharmacology, ADME/DMPK,… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Associate Director is a global program management expert responsible for managing major ... have strong knowledge of GMP Manufacturing, Supply Chain, Validation, Engineering, CMC technical development and pharmaceutical regulations + Must have demonstrated… more
- AbbVie (North Chicago, IL)
- …Job Description Purpose The PDS&T (Product Development, Science and Technology) Director of Business Development & Acquisitions translates unmet customer and market ... commercial timelines. + Identify technical gaps and/or risks associated with available CMC data. + Manage cross-functional teams comprising of functional leaders to… more
- PCI Pharma Services (Rockford, IL)
- …Location: **Rockford IL or Remote** Department: **Clinical PM** Reporting To: ** Director , Clinical Supply Chain for North America** Responsible For (Staff): **Yes** ... + Manage the project budget (protocol and program level). + Participate in CMC meeting to help manage expectations and ensure clear communication. + Supports… more