Chemistry, Manufacturing and Controls (CMC) Lead

About the role

The CMC Lead serves 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.

Responsibilities

• 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, Discovery, Clinical, Project Management) and collaborate with colleagues to develop integrated proposals.
• Represent LBG at industry conferences, client meetings, and business development events to build market visibility for CMC services.
• 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.
• 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.
• 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.
• 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.

Qualifications

• 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 is preferred.
• Experience: 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).
• 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. 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.
• 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.

Pay & Benefits

Competitive Compensation
Annual Base Salary Range: $150,000 - $180,000, commensurate with experience and qualifications
Annual performance based discretionary bonus
Robust Health Coverage
3 Medical plans
Dental and Vision
Life, AD&D and other voluntary insurance
Tax-Advantaged Accounts
401K retirement plan 4% matching and 100% vested upon enrollment
Health Savings Account (HSA)
Flexible Spending Account (FSA)
Health, Dependent Care, Commuter
Family Friendly Benefits
100% paid parental leave for all new parents with eligible tenure
Building Healthy Families program if enrolled through Medical plan
Generous Paid Time Off (PTO) policy 9 company holidays plus 1 floating holiday
Extras that Make Life Easier
College savings and student loan repayment assistance
Monthly cell phone stipend
Access to wellness programs at no cost if enrolled through Medical plan, including: Gym membership reimbursement
LiveHealth Online virtual care
Personalized support from a Well-being Coach
Diversity, Equity, Inclusion & Belonging
At Sia, we believe in fostering a diverse, equitable and inclusive culture where our employees and partners are valued and thrive in a sense of belonging. We are committed to recruiting and developing a diverse network of employees and investing in their growth by providing unique opportunities for professional and cultural immersion. Our commitment toward inclusion motivates dynamic collaboration with our clients, building trust by creating an inclusive environment of curiosity and learning which affects lasting impact.