The Opportunity: IntegerBio, a start-up biotech based in the biotech corridor of Montgomery County, Maryland, just outside Washington, DC, is building a world-class scientific team. Our company is launching with several promising assets that have been incubated and licensed by our seed funder. Led by a team of industry veterans, we’ve set our sights on harnessing the emerging science of immunovirology and creating a future free from viral illness.
The Job: Responsibilities include managing the selection, start-up, and oversight of a CDMO partner to develop, scale, and manufacture clinical trial products for our early-stage biologic assets. This role is a director-level biologics CMC lead and project manager.
Job Title: BPD/CMC CDMO Project Manager (Director level)
Primary responsibilities include:
CDMO Selection
- Guide the development of the selection criteria and statement of work (SOW) for CDMO partner and BPD supporting vendors.
- Facilitate the review and assessment of potential partners, including the RFP process.
- Participate in the negotiation of the terms of service for selected partner.
BPD/CMC Technical Management
- Oversee CDMO BPD/CMC activities ensuring adherence to quality and regulatory standards, serving as the primary IntegerBio contact and, as needed, be on-site with CDMO, ensuring product safety consistency and compliance in the development of Ph1/2 clinical material.
- Establish clear roles and responsibilities within BPD/CDMO technical areas with CDMO partner and guide operations to align with agreed ways-of-working.
- Serve as primary conduit between IntegerBio’s scientific team and CDMO on technical matters requiring IntegerBio input and clarification.
- Provide oversight and support by evaluating and ensuring integration of technical process development/CMC efforts into product plans and timelines.
- Provide technical expertise, problem-solving, and appropriate escalation on BPD/CMC matters including but not limited to, analytical development, cell line development, process development, formulation development, data interpretation, shelf-life determination, quality control, and assurance.
- Provide technical support and expertise in the development, drafting, and delivery of regulatory filings.
- Anticipate and ensure successful transition from development to manufacturing.
CDMO Partner Alliance Management
- Take lead to establish and launch CDMO engagement and onboarding, ensuring governance structure, integrated workplans, clarity of expectations, timing, roles & responsibilities, decision-making, and escalation processes – including identifying risks and guide mitigation planning.
- Ensure the seamless transfer of programs to selected partner.
- Ensure effective execution of deliverables managing cost, quality, and timing requirements (scheduling, budgeting, communications, methods for problem-solving).
- Ensure partner establishes and uses proper design, monitoring, and controls for manufacturing processes for high-quality drug products.
- Primary point of contact with CDMO partner on behalf of IntegerBio to ensure alignment and clarity to direct multi-disciplinary project team to deliver results within an agreed project governance structure.
- Clear communication to the program team including team members, management, partners, and vendors; ensure partner communicates changes and delays and escalates issues if necessary.
Requirements:
- Ph.D. or Master’s Degree in relevant biological/biomedical sciences.
- 10+ years of experience within the industry.
- CMC Biologics experience.
- Excellent project management; preference for PMP certification.
- Biopharmaceutical development (upstream, downstream, formulation, analytical).
- Pilot plant set up.
- Technology transfer.
- GMP production.
Work environment: This position is working out of the office in Gaithersburg, MD.
Physical demands: Standing/sitting at a desk for most of the day with breaks as needed, heavy lifting is not expected/required.
IntegerBio is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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