Process Sciences Controls Associate

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

• Work independently and as part of a team in a client facing environment.
• Self-motivated, adaptable, and a positive attitude
• Excellent communication (oral and written) and attention to detail
• Working with a multi-functional team to support technology transfer and scale-up of processes from Regeneron’s process development team
• Analyzing development studies, enrichment studies, process validation and characterization studies, chemical stability studies, and/or historical manufacturing data to support development of process control programs.
• Evaluating product and process risks, and providing justification for implementing process controls or for making updates to existing process control programs.
• Assessing criticality of product attributes to support creation of product specifications.
• Drafting process control documents, including Process Control Strategy documents, In-Process Control (IPC) Development Reports, and Process Performance Monitoring Plans, including setting relevant limits using appropriate scientific rationale or statistical analysis, where appropriate.
• Coordinating with stakeholders to obtain additional data as needed to support creation, updates, and changes to process control programs.
• Presenting process control program structure, rationale, and methodologies during cross-functional meetings and to senior leadership when required.
• Participating in brainstorming sessions where we look for ways to continuously improve our Process Control Development and Lifecycle Management processes.
• Completes laboratory documentation and reviews logbook data.
• Complies with all pertinent regulatory agency requirements and maintains inspection readiness

Qualifications

• BS in a Chemical Engineering or Biochemistry preferred, or related discipline
• May consider another degree discipline with relevant experience
• cGMP experience is desirable.
• Thrive working in a fast-paced environment and can multitask
• Can balance multiple assignments and perform tasks within appropriate timeframes while maintaining accuracy
• Can develop and drive scientific and/or business-related improvement ideas

Additional Information

Position is full-time, 1st shift, Monday – Friday, 8:00am-4:30pm with overtime as needed.  Candidates currently living within a commutable distance of Rensselaer, NY 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.

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