Chemistry, Manufacturing and Controls (CMC) Lead

Company Description

Sia is a next-generation, global management consulting group. Founded in 1999, we were born digital. Today our strategy and management capabilities are augmented by data science, enhanced by creativity and driven by responsibility. We're optimists for change and we help clients initiate, navigate and benefit from transformation. We believe optimism is a force multiplier, helping clients to mitigate downside and maximize opportunity. With expertise across a broad range of sectors and services, our 3,000 consultants serve clients worldwide from 48 locations in 19 countries. Our expertise delivers results. Our optimism transforms outcomes.


Sia's Life Science and Healthcare Business Unit, Sia/LBG, focuses on supporting the life sciences and healthcare industries with strategic consulting, product development and non-dilutive funding expertise. This consulting division works with healthcare organizations, pharmaceutical & biotech companies, CROs, academia, medical device/diagnostic companies, and non-governmental organizations (NGOs) alike to solve complex business, scientific, regulatory, technological and product development challenges. Our subject matter experts help advance our clients products and programs; supporting these companies-both large and small-to achieve organizational objectives and create tangible value for their stakeholders.

Job Description

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.

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 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.

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 such as biochemistry, chemical engineering, pharmaceutical sciences, biology, chemistry, or a related field 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).
• 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. Here's a snapshot of the comprehensive benefits you'll enjoy as part of Sia.


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

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 locations-New York City, Charlotte, Seattle, and San Francisco-are 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.