STAT Team Lead, 2nd shift

Responsibilities include but are not limited to:
- Perform routine assays such as UV-VIS Spectrometry, HPLC methodologies (Titer, Sialic Acid), AKTA purification, Bioburden, Endotoxin, and environmental monitoring testing in accordance with SOPs, safety, and
cGMP guidelines to support the release and stability of finished products, in-process materials, and various components
- Perform clean utility sampling Monitor critical operating parameters for equipment and instrumentation to ensure
Standard operation
- Recognize, report, and document deviations from test methodologies, specifications, and alert limits
- Maintain up to date knowledge of cGMP, job related SOPs and complete all assigned training on time
- Coordinate sample receipt, logging, tracking, storage, distribution and archival.

-Provide training for team to ensure all team training is completed in a timely manner.

-Perform troubleshooting for shift and function as point of contact for the shift in the absence of the supervisor.

-Ensure all testing is completed within timelines to ensure manufacturing incurs no delays- --

-Proficiency (or mastery) of one or more of the following test methods: HPLC, A280, TOC, Titer, bioburden, endotoxin; Technical knowledge/SME in technical discipline

-Writes and revises SOPs for managerial review and approval.

-Writes technical reports and perform data analysis and trending for both method transfers and investigations. Can effectively interact with inspectors during lab tours

-Can effectively interact with inspectors during lab tours

-Proficiency in applying cGMP regulations and compendial testing required.

-A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.

-Experience in interpreting and applying cGMPs, USP, regulatory requirements and industry best practices

-Will work in teams and have continual interaction with members of his/her team as well as other teams throughout the facility in order to exchange information regarding testing completed, in process and planned. All Leads will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions.

-Will primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. Flexibility to work overtime to meet project timelines when required.

Should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions.

*Work Shift: 12-hour 36/48 rotating MFG shift, 5pm to 5am, weekends and work holidays that fall on scheduled shift. No on call.

Qualifications:
- Knowledge of science generally attained through studies resulting in a BS/MS Degree or equiv. preferably in Biological Sciences.
- Minimum of 6 years' experience in a regulated laboratory preferred.
- Excellent manual dexterity including proficiency in aseptic techniques.
- Proficiency (or mastery) of one or more of the following test methods: HPLC, A280, TOC, Titer, bioburden, endotoxin; Technical knowledge/SME in technical discipline

Familiarity with the use of air sampling equipment, autoclaves, micro ID methods, and endotoxin testing.
- Experience requiring one to work independently as well as part of a team, to complete assignments within defined time constraints.
- Demonstrated ability to concurrently conduct multiple routine tasks, procedures, and operations effectively and consistently.

- A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.

• -Experience in interpreting and applying cGMPs, USP, regulatory requirements and industry best practices