Reports to: Senior VP, Pharmaceutical Development
Date: February, 2017
This position is responsible for the coordination, tracking, and monitoring of all stability studies and associated time points.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Provide oversight and management of the stability testing programs for API and drug product.
- Ensure that external laboratories are conducting and testing in accordance to approved stability protocols, regulatory guidelines, SOPs, and timelines.
- Review stability protocols and coordinate approvals.
- Review data and file all stability testing reports.
- Coordinate shipments of stability samples from manufacturing sites to testing laboratories, as needed.
- Collaborate with internal groups and external laboratories to resolve deviations or out-of-specification results from stability testing in a timely manner.
- Prepare stability summary tables, stability updates for regulatory filings and where appropriate, include statistical evaluation of data trend.
- Monitor re-test/expiry dates and prepare reports to extend dating as needed.
Analytical skills (familiarity with chromatographic techniques a plus)
Planning and coordination
Time Management and Organizational skills
Ability to handle multiple tasks simultaneously
Interpersonal skills – relates well to people, including inside and outside the organization, builds appropriate rapport, can diffuse tense situations comfortably
Required Education and Experience
- Typically requires a Bachelor’s degree in pharmacy, chemistry or related scientific field and a minimum of 5 years of related experience. Without degree, additional related experience is required.
- Experience in GMP quality control and/or pharmaceutical manufacturing facility
- Pharmaceutical stability operations experience
- Experience with various quality processes (e.g. investigations/deviations, CAPAs, change controls, etc.)
- Working knowledge of GMP regulations for stability programmes and laboratory applications
- Previous experience with conducting stability studies
- Experience with statistical applications for stability data evaluation and shelf-life determination
- Knowledge of FDA guidelines on Stability requirements is a plus
Additional Eligibility Qualifications
- Computer proficiency and technical aptitude with the ability to use Microsoft products, including Excel, Word, and PowerPoint. Experience with MS Project is a plus.
- Proven ability to work effectively in a team environment with associates. Capability of effective planning and priority setting. Ability to manage several complex projects simultaneously while working under pressure to meet deadlines.
- Excellent communication, organization skills and attention to detail.
Equal Employment Opportunity Employer
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.