QC Release & Stability - Chemistry Lead

Duties and Responsibilities:

Trains staff, monitors and performs testing of, in-process, release, and stability for Bulk Drug Substance and drug product samples in a cGMP environment.

Develops methods and procedures, to ensure compliance with corporate policies and procedures.

Reviews data obtained for compliance to specifications and reports abnormalities.

Provides technical and operational expertise for training and developing staff, assisting in troubleshooting and performing investigations for out of specification results.

Develops and maintain expertise in one or more test methods. Leads low risk laboratory investigations.

Reviews and revises standard operating procedures as needed.

Performs data analysis and trending for method transfers and process investigations.

Assists in troubleshooting laboratory equipment and procedures, taking required corrective action.

Back up to Lab manager/Supervisor

Knowledge and Skills:

Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent is preferred

Minimum of 4 years of experience as a senior analyst in Biologics QC lab or experience in a related biopharmaceutical GLP or GMP laboratory.

Operational knowledge of some or all of the following analytical methodologies: Appearance (color/clarity/visual particulates), Free Thiols, Protein Concentration, and particle analysis procedures (HIAC, Semi-quantitative )

Experience with LIMS and Smart lab computer applications a plus.

Proficient in common computer software applications.

Strong general laboratory and organizational skills, effective communication skills, both oral and written.

Demonstrated ability to schedule and plan work for a team

Strong attention to detail.

Previous method transfer/validation experience a plus

Operational Excellence experience

Contacts:

Direct daily interaction with all staff and management of Quality Control Chemistry. Regular interaction with other QC and QA functions in the context of assigned work. Occasional interaction with Quality employees from other sites for methods transfer and training.

Working Conditions:

Work in a cGMP laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. Work may include night shift or weekend assignments.

Decision Making:

May work on assignments that are basic in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Exercises judgment within specifically defined practices and policies in selecting methods and techniques for obtaining solutions. Coordinates with higher level leads/supervisors on decisions, and applies appropriate notification to management as appropriate. Failure to obtain results or erroneous decisions or recommendations would typically result in minor program delays.

Supervision:

Work is performed under general direction. Independently determines and develops approach to solution. Work is reviewed upon completion for adequacy in meeting objectives. May receive assignments which have a partially defined process to complete the assignment. Specific assignments are allocated based upon the recipient's demonstrated capabilities with the degree of supervisory attention determined accordingly. Failure to obtain results or erroneous decisions or recommendations would typically result in minor program delays.

Oversees and provides guidance to non-exempt staff as required in daily laboratory procedures.

No formal supervisory responsibilities