MSAT Senior Scientist Group Leader

MSAT Senior Scientist Group Leader

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Job Description

The MSAT Senior Scientist Group Leader oversees the daily operations of a group of analysts, sets clear objectives around the execution and delivery of the cGMP testing workload. The group leader also ensures that all activities within the laboratory are performed in compliance with cGMP and internal written procedures and policies. The group leader is responsible for scheduling personnel and material resources to ensure testing commitments are satisfied and communicate any difficulties to client in MSAT management. The group leader is accountable for the accuracy, integrity, and security of all results generated by the working group. The group leader measures progress, evaluates results, and takes responsibility for outcomes. The group leader is also expected to perform complex or routine analyses to ensure timelines are met.

Essential Duties & Responsibilities

• Oversee testing to ensure compliance with all applicable procedures, and timely completion
• Assist in laboratory investigations. Train analysts in the investigation process. Write or review investigation reports and other forms required by the investigation procedure.
• Ensure team is adequately trained to perform job assignments. Execute training in accordance with written procedures, this would include but is not limited to training subordinate staff, perform training assessments, document training, assist in the preparation of training programs and curricula.
• Write, revise or review SOP’s, analytical protocols, analysis reports, specifications, and controlled forms
• Review and approve data packages for submission to MSAT or QA for final disposition
• Serve as subject matter expert on operation and troubleshooting of select laboratory instrumentation
• Exhibit analytical mastery across different testing methodologies in the MSAT laboratory and serve as mentors and coaches for individuals within the MSAT testing group

Qualifications

• B.S. or M.S. degree in Chemistry, Biochemistry or related science discipline
• Approximately 4 -6 years (B.S.) or 2 – 3 years (M.S.) of cGMP laboratory and/or Pharmaceutical Quality experience
• Awareness and ability to originate action to improve the performance and compliance within the Laboratory. Uses appropriate methods to identify opportunities, implement solutions, and measure the resultant impact on the operation of the Laboratory
• Effective organization and planning skills
• Proficiency in HPLC, KF, pH, UV/Vis Spectroscopy
• Techniques preferred but not required are LC-MS, GC, GC-MS, SDS-PAGE, Capillary Electrophoresis, cell-based potency assays
• Proficiency in LIMS or similar system, Empower, Electronic Notebook (ELN) and lean laboratory operations is preferred but not required
• Proficiency cGMP regulations and laboratory safety procedures
• Proficiency in laboratory instruments/qualification program as necessary
• Ability to react quickly to changes in project priorities and timelines

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Wimington, OHare encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays