Quality - Manager, ATS

MAJOR DUTIES AND RESPONSIBILITIES:

1. Supports the technical in-process, release, and stability methods for bulk and/or drug products.
2. Performs troubleshooting to solve analytical-related problems during in-process, release, and stability testing to determine remedial steps to correctly resume testing, while guaranteeing compliance.
3. Serves as a liaison between Quality Control and other support groups (e.g. QA, Validation, and Analytical Research) to assure that current laboratory method issues are being properly addressed.
4. Designs, evaluates, and executes Analytical Method Transfer protocols.
5. Executes transfer and start up of new and existing methods into the Quality Control ensuring that critical assay parameters are clearly communicated to the receiving site.
6. Designs, executes and evaluates method development protocols to ascertain the required degree of validation for new and existing methods guaranteeing implementation of a feasible, efficient, rugged, and robust method.
7. Supports technical aspects of test method ruggedness and robustness processes.
8. Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control.
9. Coordinates projects to assure successful and timely execution, issuance and updating of detailed time and event schedules.
10. Leads analytical special projects to accomplish company goals and objectives on a timely and effective manner .
11. Evaluates analytical method deviations with respect to their causes and corrective actions to prevent recurrence.
12. Provides timely and efficient technical reports to document all analytical improvement or investigation projects.
13. Evaluates and appraises method and instrument changes in regards to regulatory requirements. Keeps current with emerging technologies, new instrumentation, and regulatory expectations relative to the pharmaceutical/development laboratory operations.
14. Trains Technical Operations analysts to perform existing and/or new analytical methods and generate training documentation as required.
15. Handles hazardous wastes in a safe manner and maintains a safe work environment. Assures compliance with all accepted laboratory and safety procedures.
16. Leads analytical technology transfers, making key decisions, which have a significant impact on project outcome.
17. Verifies consistency with other site procedures and/or specifications.
18. Verifies compliance with Client Policies and Guidelines.

KNOWLEDGE / SKILL:

• BS Degree in Natural Science in Biochemistry or Chemistry.

• The experienced required based on Degree is:

• BS Degree with five (5) years experience in pharmaceutical industry with at least two (2) years experience in method development/transfer of biomolecules.

• Master Degree with at least (2) two years experience in pharmaceutical industry in method development/transfer of  biomolecules

• PhD Degree with experience in handling, analysis, and method development of biomolecules.

• Technical knowledge of proteins handling and analysis with specific experience in biomolecules method optimization and troubleshooting.

• Broad experience with analytical instrumentation and techniques (e.g. HPLC, GC, UV, FTIR, MS, CE, SDS-PAGE, SEC, ELISA)

• Literacy of pharmaceutical industry analysis of Bulk Products and/or finished dosage forms.

• Computer literacy (Microsoft office, etc) and presentation skills (English/Spanish).

• Technical writing and oral communication skills (English/Spanish).

• Leadership skills, time management, planning and organization capabilities.

• Excellent interpersonal skills and the ability to interact with people at all levels

• Project management skills

• Knowledge of Statistical Process Control, and Design of Experiments with demonstrated analytical and problem-solving skills.

• Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.

Weil Group is proud to be an Equal Employment Opportunity Employer.