Manager - Toxicology

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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It 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. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

• Prepare hazard identification and toxicology risk / safety assessments for impurities, excipients, leachables, extractables, etc.
• Conduct SAR and QSAR modelling of unknown compounds
• Review, interpret, and position data (study reports, literature, safety data)
• Conduct technical dossier gap analysis and independent data reviews
• Validity review of performed studies
• Remain abreast of advances in the field
• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrates and promotes the company vision
• Regular attendance and punctuality
• Ensure that the quality policy program is understood, implemented, and maintained; identify, prevent, or correct any departures from the quality system
• Oversee inventory, maintenance and repair of departmental instruments, tools, equipment, materials and/or products
• Utilize the MOS to track key performance indicators and drive continuous improvement
• Manage scheduling of personnel; evaluate personnel performance
• Participate in interview process, make recommendations for new hires; oversee training and development of staff
• Ensure department maintains client confidentiality
• Review, prepare, and approve methods, data, and SOP's
• Continually evaluate systems and processes to help improve overall productivity and quality
• Investigate and solve laboratory problems
• Support and drive LEAN initiatives and operational improvements - drive projects to completion
• Support Group Leaders in meeting client objectives and developing staff
• Communicate with clients on technical and business matters - make yourself available to meet with clients to discuss operations and conduct tours and audits
• Provide technical input and guidance to clients
• Lead business review meetings, assessing and understanding P&L's
• Be involved in establishing CapEx list for coming year
• Evaluate pricing structure and provide input for changes
• Foster motivation and morale
• Perform and/or assign other duties as requested to ensure smooth operation of department Perform all functions in support of and in compliance with all state and federal employment regulations

Qualifications

Basic Minimum Qualifications:

• Bachelors Degree in Toxicology or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
• Strong understanding of the full scope of ISO 10993 as well as other relevant industry and regulatory standards
• Experience performing biological evaluations of medical devices per ISO10993 (i.e., authoring biological evaluation plans (BEPs), biological evaluation reports (BERs), and toxicological risk assessments (TRAs)
• Authorization to work in the United States indefinitely without restriction or sponsorship

The ideal candidate would possess:

• 5 years experience in performing biological evaluations of medical devices on the basis of ISO10993-17.
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Strong leadership, initiative, and teambuilding skills

Additional Information

Working schedule will be Mon-Fri 8:00am to 5:00pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.

What we Offer:

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

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