Chemistry, Manufacturing and Controls (CMC) Lead

Chemistry, Manufacturing and Controls (CMC) Lead

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, 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.

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.

Experience: Minimum of 812 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 12 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 experience in vaccines, small molecules, and/or advanced modalities (cell and gene therapy, oligonucleotides) is highly valued. Background in mid-size biotech and/or CDMO environments strongly preferred; candidates with diverse organizational experience (including start-up or early-stage companies) are encouraged to apply.

Technical Competencies: Deep expertise in drug substance process development, including upstream and downstream processing. Strong knowledge of manufacturing technology transfer, scale-up, and GMP manufacturing operations. Proficiency in CMC regulatory strategy across global regulatory frameworks (FDA, EMA, and other international agencies). Working knowledge of drug product formulation and fill/finish, analytical development and characterization, and GMP compliance/quality systems. Familiarity with supply chain management and CDMO selection, qualification, and oversight.

Business & Leadership Competencies: Business development acumen: Proven ability to identify, develop, and close consulting or service-based engagements. An established professional network within the biopharmaceutical industry is essential. Scientific credibility: Recognized by peers and clients as a trusted technical expert capable of leading complex CMC programs. Strategic thinking: Ability to connect CMC decisions to broader program goals, commercial timelines, and organizational strategy. People leadership: Track record of building, developing, and retaining technical teams. Ability to mentor junior staff while maintaining personal operational contribution. Collaborative orientation: A team-first approach with a demonstrated ability to work across functional boundaries, share opportunities, and avoid siloed behavior.

Preferred Qualifications: Experience selling CMC consulting services or working in a professional services / consulting environment. Familiarity with government-funded drug development programs (e.g., BARDA, DoW, NIH) and associated compliance requirements. Experience with European and Australian regulatory engagement from a CMC perspective. Exposure to oncology, rare disease, or infectious disease therapeutic areas. Recent BLA submission experience. Process chemistry expertise, particularly for complex synthetic modalities (peptides, lipopeptides, oligonucleotides). Broad familiarity with adjacent areas of drug development (nonclinical, clinical operations, regulatory affairs) sufficient to engage credibly as part of an integrated team.