Forest Pharmaceuticals (FPI)
—a wholly-owned subsidiary of Forest Laboratories, Inc.—manufactures, distributes and sells Forest’s robust portfolio of products, which treat conditions such as depression, anxiety, Alzheimer’s disease, hypertension and fibromyalgia. FPI’s sales force serves practitioners, hospitals, managed care organizations and pharmacies nationwide as the first point of contact for information about our health-improving therapies. FPI also operates manufacturing, packaging and distribution facilities in St. Louis, Mo., and Cincinnati, Ohio, which include customer services and sales representative support centers. With headquarters in New York City, each of Forest’s more than 5,000 employees contributes to our quest to deliver quality products with entrepreneurial spirit, unflagging integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest.
This Quality Control Chemist III is responsible for chemical analysis, generating cGMP documentation, evaluation and qualification of instrumentation, analytical techniques, current and future compendial requirements, current pharmaceutical industry practices and procedures relating to Quality Control Laboratory.
Main areas of responsibility:
- Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
- Perform routine analysis of samples submitted to the QC Lab.
- Independently write and review documents that ensure cGMP compliance e.g. analytical test methods, analytical test method development reports, method validation protocols and reports, method verifications protocols and reports, instrumentation qualification documentation (URS/IQ/OQ/PQ), and laboratory investigations.
- Effectively articulate complex scientific information in a concise and logical manor. Present information to small groups of internal and external scientist in meetings.
- Development, execution and evaluation of scientific studies to improve the performance of current analytical methods.
- Perform and lead the development and qualification of methods and sampling techniques for use in cleaning validation studies to support the Plant II product mix.
- Perform and lead the evaluation, development and execution of scientific studies to improve the performance of current manufacturing process and analytical methods.
Minimum Qualifications to be considered for this position:
- A Bachelor's degree in Chemistry or a related scientific field.
- 7+ years experience in a cGMP laboratory environment.
- 2+ years experience writing and executing protocols for method validation and/or equipment validation
- Data Review experience in a GMP environment.
- Experience operating HPLC, dissolution, UV/vis and IR test equipment and their related data acquisition and processing systems.
- Experience performing GC, TLC, TOC, disintegration, electrochemical and/or wet chemistry test methods.
- Demonstrate strong analytical laboratory skills and laboratory troubleshooting abilities.
Forest Laboratories doesn't just blend in with the trees. The company develops and manufactures prescription drugs to address a wide...