What are the responsibilities and job description for the Associate Director, Analytical Development & Quality Control position at BLOSSOMHILL THERAPEUTICS INC?
Job Summary:
The Associate Director, AD/QC will be responsible for analytical activities related to drug substance and drug product. These activities include method development, method validation, method transfer, stability testing and evaluation.
Key Responsibilities:
- Collaboration with CMC functions (drug substance, formulation, and clinical supplies), Regulatory, Pre-Clinical, and Clinical teams.
- Strong knowledge of regulatory filings (IND, IMPD, NDA, and MAA), specifically Module 3.
- Work with CDMOs and manage the work to ensure timely completion of deliverables.
- Conduct stability studies, analyze the data, and assign shelf-life.
- Set specifications for drug substance and drug product based on available data.
- Record, analyze, and present data in research group meetings.
Qualifications:
- B.S., M.S., or Ph.D. in Analytical Chemistry or related majors (e.g., Chemistry, Physical Chemistry) with 7 years of experience.
- Deep knowledge of chromatography (LC and GC) and instruments used for testing of API and drug products including dissolution, mass spectrometry (LC-MS, GC-MS, ICP-MS), titration, Karl Fischer, PXRD, DSC, TGA, FT-IR, PSD, and PLM.
- Experienced in writing regulatory documents including IND, IMPD, NDA, and MAA.
- Skilled in stability testing including protocol generation, interpretation of data, and shelf-life assignment.
- Strong knowledge of drug development phases (pre-clinical through commercial launch).
- Experienced in investigations related to deviations and OOT/OOS with excellent collaboration with the Quality Unit.
- Experienced in vendor auditing and quality risk assessment.
- Ability to present decision-making data at weekly update and progress reports to project team.
- Ability to successfully handle multiple tasks and goals with time constraints.
AAP/EEO Statement:
The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Recruiters and Agencies:
BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHills’ employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.
Salary : $165,178 - $194,719