Method Development Group Leader

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.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Responsibilities include, but are not limited to, the following:

• Lead a group of scientists to support non-routine analytical activities (method development, optimization, qualification/characterization of stability indicating methods) for early phase pharmaceutical small to medium molecules with pre-set timelines using instrumentation such as, but not limited to, UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, and KF titration.
• Lead pharmaceutical drug development program as analytical development scientist to collaborate with other departments and support formulation development and manufacturing activities with pre-set timelines.
• Participate in technical discussions with project leads to recommend alternatives, research new methods/techniques and discuss potential solutions to problems.
• Plan critical laboratory experiments to investigate aberrant results, determine root cause and recommend action plan
• Write Standard Operating Procedures (SOPs), assist in generating technical reports, prepare data for presentations/technical discussions and transfer methods internally and externally
• Prepare method protocols, & technical reports for characterization of analytical methods based on separation techniques (HPLC, UPLC, GC), Spectro-analytical technique (Ultraviolet-Visible Spectrophotometry) and dissolution testing
• Assist and mentor junior level scientists on analytical techniques and troubleshooting issues.
• Ensure project deliverables are scientifically accurate and meet timeline expectations
• Assist executive management in strategic planning, business development and expansion initiatives
• Comply with all laboratory safety guidelines including Personal Protective Equipments (PPEs)
• Maintain general cleanliness of the lab, including personal bench space and common use areas

Qualifications

The ideal candidate would possess:

• Deep understanding of analytical sciences, drug development process, GMP/GLP requirements, and pharmaceutical industry trends
• Previous experience in pharmaceutical oral solid dosage & parenteral drug product analytical testing
• Good knowledge of three main pharmacopoeias (Japanese; JP, US; USP and European; Ph. Eur.) and ICH guidelines related to method development and validation
• Experience in developing pharmaceutical small molecules analytical chemistry methods for dissolution multi-media screening and analyzing data using compendial methods
• Understanding of experimentation and data analysis using Empower software
• Excellent project management skills; Ability to communicate complex scientific findings/recommendations and project resource requirements (material, manpower, time, etc.), and elevate relevant issues to project lead and line-management
• Excellent communication (oral and written), attention to detail, effective problem-solving and decision-making skills
• Ability to work independently and as part of a team with internal and external clients, 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
• Experience in exploration and application of innovative technologies/approaches to analytical development activities
• Experience with transfer of analytical technologies
• Ability to drive performance by tracking and managing key performance indicators using internal and external metrics
• Ability to prioritize complex workloads and manage changing priorities
• Proficiency in IT related skills such as Microsoft excel, word, PowerPoint etc

Basic Minimum Qualifications:

• Bachelor's degree in analytical chemistry, Biochemistry, Chemistry 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)
• At least 15 years related experience with separation science to support pharmaceutical oral solid dosage & parenteral drug product/substance analytical testing
• At least 8 years of experience in directly supervising and managing technical staff in a pharmaceutical laboratory environment
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is Monday-Friday 8:00am- 5:00pm Overtime as needed. Candidates currently living within a commutable distance of Indianapolis, IN 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
• #LI-EB1
• Authorization to work in the United States indefinitely without restriction or sponsorship

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

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