Senior Director, Analytical Development
TITLE: Senior Director, Analytical Development
REPORTS TO: Chief Executive Officer (CEO)
DIRECT REPORTS: Range 2-4
STATUS: Full Time Exempt / Full time consultant
EFFECTIVE: Aug, 2018
Symic Bio is searching for a Senior Director in Analytical Development. Symic is open to both a full-time consultant or full-time employee. The successful candidate will lead analytical activities for projects at various stages of clinical development. Key technical responsibilities include serving as the subject matter expert for drug substance and drug product analytical methods development, transfer, validation, material specifications, and stability. This role will work collaboratively within other internal project teams including Project Management, Quality, and Regulatory, and with external contract organizations as well. This position reports to the Chief Executive Officer (CEO).
- Manage development and validation of analytical methods at contract laboratories for release and stability testing for drug substance and lyophilized drug product.
- Manage internal analytical team for development and execution of studies both internally and with contract labs.
- Participate in selection of third party testing laboratories, and oversee phase-appropriate method validation, method transfer, testing plans, and data verification.
- Provide input into experimental designs and critically review validation protocols and reports. Review and interpret analytical data for drug substance and drug product, and effectively communicate results.
- Establish phase-appropriate specifications and control strategies for starting materials, intermediates, drug substance, excipients and drug product and author justifications of all specifications
- Manage formal and informal stability studies, apply statistical methods of analysis, and guide project team activities based on stability outcomes.
- Work closely with Quality to assess and approve method change controls, investigate OOS and OOT test results, and assure that corrective actions are implemented.
- Author and review regulatory documents (IND, IMPD, NDA, DSUR) and support regulatory submissions and responses.
- Lead analytical activities for programs at all stages of development, and represent the Analytical Development function on cross-functional CMC teams.
- Collaborate effectively with the Project Management, Quality, and Regulatory groups to meet program goals.
- A Ph.D. in chemistry with 5 or more years of relevant experience in pharmaceutical analytical methods development and validation, or M.S. in chemistry with 10 or more years of relevant experience.
- A track record in leading analytical development activities in various stages of development.
- Deep practical experience in a range of analytical techniques including HPLC (including RP, IEX, SEC), mass-spec, NMR, UV, and IR, and have demonstrated experience developing such assays through Validation.
- Experience with sterile dosage forms preferred
- Strong oral and written communication skills, with experience in preparing stability and validation protocols, technical reports, and regulatory filings.
- Knowledge of regulatory and compendial guidance (FDA, ICH, USP) and practical experience in meeting requirements in a phase-appropriate manner.
- Management experience with successful track record leading motivated cross-functional teams.
- Experience interfacing with FDA and preparing regulatory documents.
- Experience working and maintaining relationships with external contract organizations, and demonstrated ability to build and manage relationships with business partners.
- Ability to manage collaboratively across diverse functions, operate independently, and build strong networks throughout the corporate organization.
- Ability to prioritize and align functional activities with goals and objectives, and ensure operational excellence.
- Experience with polymers, bioconjugates, and/or peptides is preferred, but not required.
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
- Approximately 20% domestic/international travel