QC STAT Team Lead, 1st Shift

Qualifications:

Knowledge of science generally attained through studies resulting in a BS/MS Degree or equiv. preferably in Biological Sciences

A minimum of 6 years' experience in Biologics QC laboratory or related biopharmaceutical cGMP lab.

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

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

Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints

Proficient in lab software application such as LIMS, SmartLab, etc.

Proficiency in applying cGMP regulations and compendia testing required.

Can effectively interact with inspectors during lab tours

Performs method transfer/ routine testing and data review of in-process, and Bulk Drug Substance samples in a cGMP compliant environment.

Performs method transfer/ routine assays such as UV-VIS Spectrometry, TOC, and more complex assays includingvarious HPLC methodologies.

Writes and revises SOPs for managerial review and approval.

Writes technical reports and performs data analysis and trending.

Performs and Leads broad range of equipment troubleshooting.

Trains less experienced analysts on basic and complex test methods.

Perform routine testing and data review ofin-process samples in a cGMP compliant environment.

Additional Responsibilities include:

-The QC STATLead willhave 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. The team lead will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions.

-He/She will 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. As essential personnel, when on shift, the applicant will be required towork holidays, during inclement weather, and occasional overtime to meet project timelines when required.

-He/Shemustbe observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions.

-Performs routine assays such as UV-VIS Spectrometry, sample receipt, TOC testing, )and more complex assays including various HPLC methodologies.

-Writes and revises SOPs for managerial review and approval. Leads equipment troubleshooting activities and investigates out of specification results.

-Trains less experienced analysts on basic and complex test methods. Writes technical reports (for example Investigations or Qualification) and perform data analysis and trending for both method transfers and investigations.