Director of Analytics

Location
Redwood City, CA
Posted
Jun 24, 2019
Required Education
Bachelors Degree
Position Type
Full time

Director of Analytics
 

About Foresee Pharmaceuticals
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange. Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology and derived drug products targeting specialty markets, and its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs. Foresee's product portfolio includes late stage and early stage programs such as FP-001, 6-month and 3-month, stable, ready-to-use versions of leuprolide mesylate depot for injection, for which regulatory submissions are planned in 2019; FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in a Phase 2 proof-of-concept study; FP-045, a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently in planning (Fanconi Anemia; mitochondrial-mediated diseases); and FP-004, a novel, subcutaneously injectable depot product in development for the treatment of opioid use disorder and pain. Please visit www.foreseepharma.com for more information.
 

Job Description
Director of Analytics, reporting to the Head of Pharmaceutics & Manufacturing, will lead and manage the planning and execution of all analytical activities, including release testing of drug substance and drug product, method development and validation, and stability studies. The individual, acting as an in-house analytical expert and working with QA and regulatory colleagues, will play an important role in establishment of specifications and shelf life of drug substance and drug product and contribute to the CMC section of regulatory filing.
Concrete responsibilities include,
• Participate in and contribute to strategic planning of analytical activities and advise project teams on regulations and guidance with respect to analytical activities for phase I-IV development
• Oversee and manage development and validation of analytical methods, transfer of analytical methods to a 3rd party analytical lab, review and approve transfer protocol and transfer reports; manage all related activities
• Oversee release testing of drug substance and drug product; review and QC testing results
• Oversee stability studies of drug substance and drug product; review and approve stability protocol, stability data and reports; monitor stability studies for proper execution
• Review deviations related analytical work and follow up on CAPA
• Provide technical input to and/or create specifications of drug substance, drug product and any other necessary component of a drug product; recommend and justify shelf life of drug substance and drug product
• Write the analytical part of CMC section of regulatory filing; review the CMC section of regulatory filing
• Function as an in-house analytical expert and provide technical support to all analytical activities
 

Requirements
• Ph.D. in chemistry or pharmaceutical sciences with minimum 10 years of experience in management of analytical activities of small molecule therapy. M.S. and B.S. in chemistry or pharmaceutical sciences with proper and adequate experience will be considered
• In-depth knowledge of analytical sciences and hands-on experience in every aspect of analysis of drug substance and drug product
• Knowledge and understanding of GMP and GXP guidelines and regulatory requirements with respect to analysis of drug substance and drug product
• A track record of management of analytical activities internally and externally
• Ability of strategic thinking, problem-solving, working independently and working up/down and across organizational lines
• Effective and efficient verbal and written communications