The Associate Director, Technical Operations and Manufacturing provides strategic and tactical support for new and ongoing projects and programs within the Product Development department, including formulations and analysis for projects in pre-clinical, clinical and commercial development. Provides expertise in Drug Substance (API) and its sourcing, Drug Product and Packaging. Requires skills and expertise to source and assemble the equipment terrain needed for the smooth manufacturing of sterile, cGMP, and finished drug products including CCS. This expertise translates in skillful and competent application of knowledge to solicit, select, and implement Contract Manufacturing Organizations across the globe in alignment with Xeris corporate and departmental goals.
- Oversee contract operations (CMOs, CDMOs, CROs, etc.). Responsibilities include, but may not be limited to:
- Establishing Contract relationships
- Vetting and selecting appropriate Contract suppliers through the Xeris Supplier Management process
- Managing coordination of raw, intermediates and final products through the global supply chain
- Managing coordination of sourcing equipment terrain, especially for the Xeriject platform and CCS through the global supply chain
- Managing successful Tech Transfers from Xeris R&D to CMO and CMO to CMO if needed.
- Manage and oversee production operations at contract sites
- Coordinate with other outsource labs for product testing and release of cGMP materials
- Mange and Adhere to PD/agreed-upon budgets
- Author Drug Substance and Drug Product sections of the eCDT for INDs and NDAs
- Support the development programs at Xeris in conjunction with other R&D colleagues, CMC, QC, QA and Regulatory. Responsibilities include, but may not be limited to:
- Establishment and meeting team objectives for all assigned projects
- Lead team members on key issues and investigations, as needed.
- Managing the project team toward implementation of the operational plan at the CMOs, CDMOs, CROs sites
- Creating/Maintaining project timelines both internal and external (CMOs, CDMOs, CROs)
- Identifying external resources to complete tasks which cannot be handled internally
- Developing and tracking project budgets in Excel
- Facilitating discussions and collaborations to understand dependencies and risks to project objectives
- Periodic reporting of project status to Management as advised
- Position will require periodic working in the lab as needed to evaluate critical functions.
- PhD. Degree in a Chemical Sciences discipline and/or Chemical Engineering. Lower level degree will be considered with demonstrated experience
- Minimum of 10 years of increasing experience in Chemistry, Manufacturing and Controls and Production and/or Technical Operations in the pharmaceutical finished products area, including pharma-device combination products
- Experience in Sterile manufacturing of pharma finished products is required.
- Proficient in injectable drug product manufacturing process, with successful CMO management experience.
- Strong knowledge and demonstrated practice of cGMP.
- Competencies: Project Management, Adaptability, Problem Solving, Self-Motivated, Collaboration, Technical Writing and Presentation skills, Written and Verbal Communication skills, Vendor Management, Microsoft Office, Organization