Biologics Manager--Eurofins - Eurofins PSS Insourcing Solutions, LLC

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 labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

The Manager has 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 biologics 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, RP-UPLC, HPLC/UPLC, CE-SDS, ELISA, Cell based Potency, icIEF, Protein Concentration by UV/Vis or SoloVPE, SEC 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.
• 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.
• Represents group and Eurofins at selected conferences, meetings and workshops.
• May lead complex analyses in the laboratory.
• Ensures laboratory area meets regulatory, resource and safety requirements.

The ideal candidate would possess:

• Demonstrated leadership and vision in managing staff groups and major projects or initiatives involving analytical testing and characterization of biologics (monoclonal antibodies, vaccines, proteins and peptides.
• Familiar with Empower and Biochemistry Analytical Techniques would be advantageous.
• Knowledge of cGMPs and related compliance regulations and guidance(s) required.
• Knowledge of CE, HPLC, ELISA and cell based methodologies.
• Must have experience with the various products and services including stability studies, method development and validation, LIMS, and ELN.
• Prefer contract laboratory experience
• A demonstrated commitment to high professional ethical standards and a diverse workplace. 
• Excels at operating in a fast pace, community environment. 
• Highly organized and able to find/communicate information in a timely manner. 
• Excellent people manager, open to direction and a collaborative work style and commitment to get the job done. 
• Ability to challenge and debate issues of importance to the organization. 
• Ability to look at situations from several points of view. 
• Persuasive with details and facts. 
• Delegates responsibility effectively. 
• High comfort level working in a diverse environment.

• Bachelor’s degree in relevant field such as chemistry, biochemistry, immunology, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework in the above areas and a minimum of five years of experience in a directly relevant setting.
• Master’s degree in a relevant field and three years of directly relevant experience may be substituted for the bachelor’s degree and experience.
• PhD in a relevant field may be substituted for bachelor’s degree and experience.

Position is Full-Time, Monday-Friday 8:00 a.m.-4:30 p.m., with additional hours, as needed.  Candidates currently living within a commutable distance of Portage, MI are 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

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.