Chemistry, Manufacturing and Controls (CMC) Lead

Responsibilities

• Business Development & Revenue Growth
• Drive the identification, pursuit, and closure of CMC consulting engagements, leveraging an established industry network and the broader Sia Partners platform.
• Develop and execute a growth strategy for the CMC practice area, including service line expansion and revenue targets aligned with LBG's 3-5 year strategic plan.
• Proactively identify cross-selling opportunities across PD functional areas (Regulatory, Quality, Nonclinical, Clinical, Discovery, Project Management) and collaborate with colleagues to develop integrated proposals.
• Build and maintain relationships with prospective and existing clients, with particular emphasis on small-to-mid-size biotech companies and government-funded programs.
• Represent LBG at industry conferences, client meetings, and business development events to build market visibility for CMC services.
• Technical & Scientific Leadership
• Serve as the senior CMC subject matter expert on client programs, providing hands-on guidance across drug substance process development (upstream/downstream), manufacturing scale-up and technology transfer, and CMC regulatory strategy.
• Lead and personally contribute to IND-enabling activities, early process development, GMP readiness, and clinical supply strategy for Phase 1-2 programs.
• Provide strategic CMC input across the full development lifecycle, including Phase 2b-3 pivotal studies, BLA/NDA submissions, and post-approval lifecycle management as needed.
• Advise clients on global CMC regulatory requirements and develop actionable manufacturing development plans from non-GMP development through commercial-scale supply.
• Evaluate and recommend CDMOs and contract manufacturing partners; manage external manufacturing relationships and oversee technology transfer activities on behalf of clients.
• Maintain technical breadth across biologics/large molecules, vaccines, small molecules, and advanced modalities (cell and gene therapy, oligonucleotides) to support the diversity of LBG's client portfolio.
• Team Building & People Leadership
• Build, mentor, and retain a high-performing CMC team capable of supporting a growing portfolio of client engagements.
• Identify and fill technical skill gaps within the CMC group through strategic hiring and professional development.
• Foster a collaborative, non-siloed culture within the CMC function and across the broader PD organization.
• Ensure billable utilization of CMC team members through effective resource planning and project staffing.
• Cross-Functional Collaboration & Communication
• Partner with Regulatory, Quality, Nonclinical, and other PD functions to deliver integrated product development solutions to clients.
• Proactively communicate CMC risks, timelines, and opportunities to internal stakeholders and client teams.
• Ensure transparency in proposal development and project pipeline so that adjacent functions can identify collaboration and cross-selling opportunities.
• Engage directly with regulatory agencies (FDA, EMA, and others) on CMC matters as required by client programs.
• Education
• Bachelor's degree (B.S.) in a relevant scientific discipline such as biochemistry, chemical engineering, pharmaceutical sciences, biology, chemistry, or a related field is required.
• Advanced degree (Ph.D., Pharm.D., or M.S.) in a relevant scientific discipline such as biochemistry, chemical engineering, pharmaceutical sciences, biology, chemistry, or a related field is preferred.

Requirements

• Minimum of 8-12 years of progressively responsible CMC experience in the biopharmaceutical industry.
• Hands-on technical experience (not solely oversight) in drug substance process development, manufacturing scale-up, and/or CMC regulatory strategy.
• Direct experience supporting IND filings and clinical-stage manufacturing programs (Phase 1-2 required; BLA/NDA experience strongly preferred).
• Demonstrated experience managing CDMO relationships, technology transfers, and external manufacturing partnerships.
• Experience across multiple modalities, with primary depth in biologics/large molecules. Complementary expe

Additional Information

Position Summary The CMC Lead will serve as the functional head of LBG's Chemistry, Manufacturing & Controls practice, responsible for both the technical leadership and commercial growth of CMC service offerings. This is a dual-mandate role: the successful candidate will provide hands-on scientific and operational expertise to client programs while simultaneously building the CMC practice area through business development, team building, and cross-functional collaboration. This individual will work closely with the Managing Director, functional area leads across Regulatory, Quality, Nonclinical, Discovery, Clinical, Project Management, and Government Services, as well as external CDMO partners and regulatory agencies. The role requires a versatile, operationally grounded professional who thrives in a consulting environment and can credibly engage at both the bench and the boardroom level.

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