Group Leader - Biochemistry Release and Stability - Eurofins BioPharma Product Testing Columbia, LLC

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelingis accurate.Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In 2019, Eurofins generatedtotal revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins BioPharma Product Testing-Columbia has delivered expert scientific support to companies working to improve human and animal health. As a member of the Eurofins BPT Columbia team, you'll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment.

Job Description

TheGroup Leaderhas an overall responsibility for providing technical leadership, laboratory/project organization and scheduling for assigned staff. Responsible for meeting project timelines. Performs a dual role by working "hands-on" in the laboratory and responsible for more complex experimentation and training, while functioning as a supervisor in the laboratory.

Responsibilities include:

• Responsible for management of the day-to-day laboratory activities. Identifies and recommends training needs and mentors staff members. Provides technical laboratory oversight and serves as technical resource for the division and clients. Typical analyses for release and stability include appearance, pH, MFI, RP-UPLC, KF (Moisture Content), HPLC/UPLC (various detectors), CE-SDS, icIEF, Protein Concentration by UV/Vis or SoloVPE, SEC and Specific Activity, and LC-MS.
• Responsible for incorporating outsourced analyses (both internal and external) into CoAs and reports, and shipping samples/materials as dictated by a study protocol and/or the client.
• Collaborates to complete investigations and to meet investigation timelines. Identifies root cause and develops corrective action plan. Prepares necessary and/or required reports according to standard operating procedures and GMP guidelines. Responsible for the completion of CAPAs and Effectiveness Checks.
• Responsible for inputting data into Eurofins LIMS for reporting to clients. Responsible for addressing data review comments and Quality Assurance comments.
• Provides staff supervisory functions in areas of hiring, titling, discipline and retention. Monitors and takes appropriate action on employee performance (rewards or corrective action). Works with employees to ensure greatest success and performance.
• Manages resources (facilities, equipment, and staff) necessary to complete projects and studies according to Eurofins and client needs. Works with other leaders and directors to ensure timely execution and completion of projects and studies.
• Guides multiple projects and studies through workflow, taking into consideration varying deadlines. Ensures and takes ownership of all quality issues and goals.
• Provides or arranges appropriate training for staff including, but not limited to, orientation of new or transferring staff, staff being reassigned to new areas of responsibility, etc. Ensures training is sufficient to provide for high quality, efficient, and timely completion of projects and studies.
• Maintains and guides implementation of organizational policies and procedures in compliance with state, federal, and other regulatory guidelines.
• Serves as leader and mentor to assigned staff. Communicates readily and clearly, maintains an open-door policy and works to enhance employee morale.
• Communicates clearly and effectively with clients and Eurofins staff and leadership.
• Evaluates actual project time and material estimates to ensure projects are completed according to client and Eurofins guidelines, and when necessary, takes appropriate corrective action.
• Provides assistance to marketing, sales, and business development relating to area of responsibility.
• Works collaboratively with program management, business development, director and senior management to respond to requests for proposals.
• Represe