Chemistry, Manufacturing and Controls (CMC) Senior Lead

Position Summary

The CMC Lead will serve as the functional head of LBGs 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.

Key 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 LBGs 35 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 12 programs.
• Provide strategic CMC input across the full development lifecycle including Phase 2b3 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 LBGs 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.

Qualifications :

Education

• Bachelors 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 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 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.

Additional Information :

Compensation & Benefits 

We believe in supporting our team professionally and personally. Heres a snapshot of the comprehensive benefits youll enjoy as part of Sia. 

Competitive Compensation 

• Annual Base Salary Range: $180000 - $200000 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 

Time Off to Recharge 

• 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. Please visit our website for more information.  

Sia is an equal opportunity employer. All aspects of employment including hiring promotion remuneration or discipline are based solely on performance competence conduct or business needs. 

Office Workplace Guidelines 

Sia is committed to providing a flexible workplace environment that supports client business and market needs. Consultants located in our primary market office locationsNew York City Charlotte Seattle and San Franciscoare expected to live within a reasonable commuting distance and attend the office at least three days or more per week. For Consultants outside of our primary markets we can offer more flexible in-person requirements in accordance with your location. 

Work Authorization & Sponsorship 

At this time Sia does not intend to employ any applicant who will require either now or in the future employment visa sponsorship or sponsorship for work authorization (i.e. H1-B visa F-1/OPT) or STEM OPT TN etc).

Sia is an equal opportunity employer. All aspects of employment including hiring promotion remuneration or discipline are based solely on performance competence conduct or business needs. 

Remote Work :

No

Employment Type :

Full-time