The Vice President of CMC is the senior executive accountable for end‑to‑end Chemistry, Manufacturing & Controls strategy and execution for a late‑stage, first‑in‑class fixed-dose combination biologic drug candidate comprising monoclonal antibodies and oligonucleotides. Reporting to the CSO, the VP oversees Drug Substance, Drug Product and Analytical operations focusing on technology transfer, scale-up, process characterization, and process validation at various Contract Development and Manufacturing Organizations (CDMOs). The role drives CMC activities from Phase 2 through BLA submission, commercial launch, and lifecycle management, ensuring global regulatory compliance, robust supply, and cost‑effective scalability.

Principal Duties and Responsibilities include the following:

The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.

Strategic Leadership

• Define and communicate a phase‑appropriate CMC vision and multi‑year roadmap aligned with corporate objectives, risk profile, and funding strategy.

Drug Substance (mAbs & oligonucleotide)

• Oversee the activities of Drug Substance development group providing strategic guidance
• Direct upstream / downstream process development, tech‑transfer, scale‑up, process characterization and validation (PPQ) at Chinese and US CDMOs; ensure comparability across sites and batches.
• Monitor supply‑chain and inventory.

Drug Product

• Oversee the activities of Drug Product development group providing strategic guidance
• Lead development of antibody/oligo co‑formulations, fill‑finish, and container‑closure selection
• Oversee US‑based DP CDMOs for GMP clinical and commercial supply.
• Drive drug product and manufacturing process characterization, optimization, and validation
• Drive formulation robustness, quality target product profile (QTPP), and stability program.

Analytical Sciences & Manufacturing Science & Technology

• Ensure development, qualification/validation, lifecycle management, and trending of release, stability, and in‑process assays; oversee reference standard and potency programs.
• Drive Product Quality programs
• Oversee Stage 1‑3 process validation, continued process verification and continuous improvement.

Regulatory & Quality

• Serve as CMC lead for global regulatory submissions, authoring Module 3 and briefing packages; represent the company in agency meetings and inspections.

Review pharmaceutical development reports and other technical documentation required for regulatory submissions, including authoring, review, and approval of requisite sections of the IND, BLA, briefing packages or other regulatory submissions.

• Partner with QA to maintain phase‑appropriate cGMP systems across internal and external operations; drive readiness for PAI.

• Implement Quality by Design (QbD) principles and adhere to current Good Manufacturing Practices (cGMP) to ensure compliance with regulatory standards.

External Partnerships & Vendor Management

• Select, negotiate, and manage CDMOs, CROs, and critical suppliers; implement clear and robust governance to ensure cost, quality, and timeline performance.
• Lead technology transfer activities to and from CDMOs, ensuring seamless transition of processes and methodologies.
• Plan and supervise scale-up activities to support new manufacturing processes needed to support clinical trials, registration, and commercial product launch.
• Develop risk-based strategies for technical oversight, considering product lifecycle, technical complexity, and CMO capabilities.

People & Budget Leadership

• Build, mentor, and retain a high‑performing CMC group (DS, DP, Analytical); foster a culture of scientific rigor, collaboration, and accountability.
• Develop and control departmental budgets; present scenario‑based forecasts to Finance, Commercial and Operations Teams.

Supervisory Responsibilities

• Direct reports: Heads of Drug Substance, Drug Product, Analytical Development, and CMC Project Management.
• Indirect reports: Staff scientists & engineers; external CDMO teams

Qualification Requirements:

1. Education:

• Ph.D. (preferred) or M.S. in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.

2. Experience:

• Over 15 years of experience in CMC, including more than 8 years in senior leadership roles within the pharmaceutical or biotechnology industry, specializing in pharmaceutical development with a focus on biological drugs, particularly antibody drugs, and expertise in process development and manufacturing of biological drug substance.
• Proven success leading IND ➔ BLA (or MAA) filings and commercial launch of at least one late‑phase biologic.
• Hands‑on oversight of global CDMOs (China‑U.S. interface strongly preferred).
• Demonstrated experience in process development, scale-up, technology transfer, and product and process validation for biological drug substances.
• Technical expertise in antibody & oligonucleotide process development, co‑formulation science, analytical control strategies, PPQ, CPV, cGMP / ICH guidelines, and digital quality systems.
• Deep knowledge of FDA and EMA expectations; direct participation in pre‑approval inspections.

2. Knowledge/Skill:

• Strategic thinker with strong execution, cross‑cultural communication (Mandarin proficiency a plus), change‑management, and talent‑development capabilities.
• Excellent leadership, organizational, and project management skills.
• Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed.
• Outstanding communication and collaboration skills within cross-functional teams and external organizations.
• Ability to work in a fast-paced virtual environment.
• Flexibility to travel domestically and internationally as required
• Excellent leadership, organizational and project management skills.

Working Conditions:         

1. Specify work environment:

• The work environment shall be split between a virtual office environment and the Company headquarters in Fort Lauderdale, FL.
• Domestic and international travel up to 25%
• Ability to lift up to 25 pounds
• Regularly required to stand, sit, talk, hear, and use hands
• Prolonged periods of sitting and standing

 

Syncromune is an Equal Opportunity Employer.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range: $280,000-$320,000

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.