Senior Director of Analytical Development

The Senior Director of Analytical Development is responsible for providing strategic and operational leadership for all analytical development and analytical quality control activities supporting late‑phase drug substance development, drug product formulation discovery, and drug product manufacturing and formulation development within the CMC group. This role oversees analytical method development, qualification, validation, transfer, and lifecycle management for single‑ and multi‑component biological products, with emphasis on antibodies and oligonucleotides.

The Senior Director will lead and develop an internal analytical organization, directly managing a team of Managers, Associate Directors, and Director across method development and analytical QC, while providing technical and managerial oversight of external CROs, CMOs, and testing laboratories. The position requires close collaboration with formulation, manufacturing, quality, regulatory, and project teams to ensure phase‑appropriate, compliant, and efficient analytical strategies that support clinical and future commercial development

Principal Duties and Responsibilities include the following:

Strategic and Technical Leadership

• Define and execute the analytical development and analytical QC strategy across drug substance and drug product programs, ensuring alignment with CMC, regulatory, and corporate objectives.
• Provide scientific and technical leadership for analytical methods supporting identity, purity, potency, content, impurities, degradation products, and stability of biological drug substances and drug products, including multi‑component combinations.
• Establish phase‑appropriate analytical control strategies for late‑phase development, including in‑process controls, release testing, and stability programs.
• Drive CQA generation and support QTPP development for late-stage project development .
• Drive control of product specifications in collaboration with other functional groups.
• Oversee development and implementation of novel or non‑standard analytical approaches required for complex biological products.

People and Organization Leadership

• Directly oversee and develop a team of at least four professionals at the Manager to Sr. Director level, including: Method Development and Analytical Quality Control, including stability, testing records, and data analysis
• Set clear objectives, provide coaching and mentorship, conduct performance evaluations, and support professional development of the analytical team.
• Ensure effective coordination and workload prioritization across method development and analytical QC functions.

Method Development, Validation, and Lifecycle Management

• Oversee analytical method development, qualification, validation, transfer, and supplemental validation activities across internal and external laboratories.
• Ensure robust implementation, execution, troubleshooting, and continuous improvement of core analytical and bioanalytical assays.
• Review and approve analytical protocols, reports, SOPs, and technical documentation suitable for regulatory submission.

Analytical Quality Control and Stability Oversight

• Provide leadership and oversight for analytical QC activities, including GMP testing, stability studies, data trending, and lifecycle monitoring.
• Manage product and raw material specifications and product shelf-life/stability protocols.
• Ensure appropriate oversight of stability protocols, shelf‑life assignments, data review, and interpretation in support of late‑phase programs.
• Oversee review of testing records, analytical data packages, Certificates of Analysis, and investigation reports.
• Lead or support investigations related to OOS, OOE, deviations, and analytical discrepancies, including root cause analysis and corrective actions at CROs/CMOs.

External Partner and Vendor Oversight

• Manage and oversee analytical activities performed by CROs, CMOs, and external testing laboratories, ensuring quality, timelines, and cost control.
• Provide technical oversight and decision‑making support for outsourced analytical development, validation, and QC activities in a virtual operating model.
• Participate in vendor selection, scope definition, budgeting, and performance management.

Regulatory and Compliance Support

• Author, review, and approve analytical sections of CMC documentation for INDs, BLAs, and other regulatory submissions.
• Ensure compliance with cGMP, GLP, ICH guidelines, FDA guidance, and relevant pharmacopeial standards.
• Partner closely with Quality and Regulatory Affairs to support inspections, audits, and regulatory interactions.

Cross‑Functional Collaboration

• Collaborate closely with formulation discovery and development, drug substance and drug product development, drug substance and drug product manufacturing, quality, regulatory, and project management teams.
• Provide analytical expertise to support formulation discovery, formulation development, process characterization, and late‑phase manufacturing activities.

Supervisory Responsibilities:

• Direct reports: Managers to Associate Directors within Method Development and Analytical Quality Control.
• Indirect Reports: supervise activities at CMOs, CROs and external resources (i.e. consultants)

Qualification Requirements

Education:

• Master or PhD in Chemistry, Biochemistry, or Analytical Science

Experience:

• At least 15 years of experience in analytical development and validation activities for biologicals, including product development and manufacturing.
• Experience with liquid biological injectable dosage forms, drug formulations of individual and combination products, is highly preferred.
• Experience with analytical techniques applicable for characterization of proteins, antibodies and/or oligonucleotides highly preferred.
• Experience in complex single or tandem mass-spectrometry technologies used for characterization of proteins, oligonucleotides and their impurities is highly valued.
• Comprehensive understanding of the dosage form manufacturing process development, scale-up, optimization and validation processes.
• Strong scientific and operational background in the optimization and validation of compendial, biochemistry, HPLC, immunochemical and cell-based assays
• Proven ability to provide analytical expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies.
• Experience working in a GMP/GLP regulated environment and deep understanding of phase appropriate method qualification, validation, sample analysis, GLP, GMP requirements, ICH guidelines and FDA guidance.
• Experience authoring and reviewing IND and/or BLA submissions.
• Expert knowledge of advanced principles, concepts, and theory related to product and process development.
• Experience in preparing budget and managing expenses.
• Skilled at managing CROs and CDMOs.

Knowledge/Skill:

• Strong leadership, organizational, and project management skills.
• Excellent written and verbal communication skills; strong technical writing and document review capabilities.
• Ability to operate effectively in a remote and virtual work environment.
• Demonstrated ability to collaborate across cross‑functional and geographically distributed teams.
• Detail‑oriented with exceptional documentation practices.
• Knowledge of U.S. and Chinese Pharmacopeia methods for biologic drugs is a plus.
• Proficiency in English required; Mandarin proficiency is a plus.
• Flexibility to travel domestically and internationally as needed.

Working Conditions:

1. Specify work environment:

• Work from home.
• Support collaboration with non-U.S. CDMO partners by accommodating meetings outside core working hours, including early morning, evening and/or nighttime sessions when necessary
• Domestic and international travel up to 25%.
• Regularly required to stand, sit, talk, hear, and use hands, with 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:  $250-$280K

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