Director CMC / CDMO Program Management

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.