Note: The job is a remote job and is open to candidates in USA. Syncromune® is seeking a Senior Director of Analytical Development to provide strategic and operational leadership for analytical development and quality control activities. This role will oversee method development and analytical QC while managing a team and collaborating closely with cross-functional groups to ensure compliance and efficiency in drug development processes.
Responsibilities
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Skills
- Master or PhD in Chemistry, Biochemistry, or Analytical Science
- At least 15 years of experience in analytical development and validation activities for biologicals, including product development and manufacturing
- 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
- 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
- Proficiency in English required
- Flexibility to travel domestically and internationally as needed
- Experience with liquid biological injectable dosage forms, drug formulations of individual and combination products
- Experience with analytical techniques applicable for characterization of proteins, antibodies and/or oligonucleotides
- Experience in complex single or tandem mass-spectrometry technologies used for characterization of proteins, oligonucleotides and their impurities
- Knowledge of U.S. and Chinese Pharmacopeia methods for biologic drugs
- Proficiency in Mandarin
Benefits
- Cash incentive compensation
- Equity incentive compensation
- Employee benefits under the Company’s benefit plans
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