Associate Downstream Engineer - Eurofins USA PSS Insourcing Solutions

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.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

• Sitting within R&D, Pilot Plant is at the interface between lab-scale studies and full-scale GMP manufacturing and operates at the 50-1000L bioreactor scale. The individual in this role will be a key member supporting/leading large scale downstream operations and development experiments, including chromatography, ultrafiltration/diafiltration, and/or depth/sterile/nano-filtration of non-GMP batches to support program timelines. The individual will independently execute both routine and complex operations. Additionally, this position plans unit operations/experiments and drafts support documentation (SOPs, batch records, and/or reports). They will collaborate within our multi-disciplinary environment including the upstream/downstream pilot team, process development, manufacturing, and manufacturing sciences teams. They will possess excellent problem-solving abilities and hold strong coaching and supervisory skills. They will apply knowledge from various technical areas, industry practices, and standards, and provide quality and productive output that is consistently timely, reliable, and reproducible. This role is a predominantly lab-based and will interact closely with counterparts in Process Development, Analytical Development, and Manufacturing Sciences.
• 50% of the time: Perform/lead non-GMP purification campaigns (pilot scale) to support new product development, material supply needs and demonstration runs for multiple programs spanning all phases of biopharmaceutical development.  Lead project team to support the transfer of all information including long lead items, batch record development, sample plan building, ordering and vendor management, and on-floor support schedules. Record, trend, and interpret data independently, and organize and present issues and results at departmental and project meetings. Identify complex technical issues and implement solutions under supervision.
• 20% of the time: Actively participate and interact with process development groups to identify and troubleshoot problems, support large scale studies, and support project goals. Design and develop pilot scale operating procedures and records suitable for use in the production of non-GMP material. Author documents such as reports, protocols, and internal presentations that may require substantial edits. Assist senior personnel with publications, external abstracts, and presentations, as needed.
• 15% of the time: Evaluate and implement novel large scale technologies that meet a generic platform across multiple processes. Mentor junior members of team in developing required skillsets.
• 10% of the time: Evaluate and implement novel large scale technologies that meet a generic platform across multiple processes.
• 5% of the time: Mentor junior members of team in developing required skillsets.

Education and Experience:

• Associate’s degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 7 years relevant industry experience
• Bachelor’s degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 5 years relevant industry experience
• Master’s degree in chemical engineering, biotechnology, chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3 years relevant industry experience
• Previous Process Development, Manufacturing Sciences, or Manufacturing hands-on experience working with bioreactors/fermenters from bench top to production scale, including process monitoring and process control.

Knowledge and Skills:

• Analytical and Problem-Solving Skills -Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information. Stands accountable and consistently follows through on work assignments and personal objectives to deliver high quality results despite obstacles.
• Teamwork -- Ability to work within department groups/team.
• Communication Skills - Expresses one’s self clearly and concisely within function; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor.
• Organization – Exercises good time management skills. Effectively manages multiple priorities and outcomes of critical tasks.
• Technical - Proficient in use of applicable lab equipment and operations
• Ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes.
• Ability to lift, pull, or push equipment requiring up to 25-75 lbs of force.
• Ability to stand for 6 hours in a suite.
• Ability to climb ladders and work platforms.

The candidate should possess knowledge of, experience in, and troubleshooting of activities routinely performed in downstream processing (e.g., traditional and continuous chromatography, UF/DF, filtration, column packing, and buffer preparation). Practical experience around scale-up, technology transfer, and manufacturing support of large scale GMP operations is desired. Knowledge of upstream processing is a plus.

The candidate must demonstrate excellent written and verbal communication skills and have an ability to independently operate pilot scale equipment, interpret data and maintain an organized lab area.  In addition, the individual should be a self-starter and be able to communicate effectively with external and internal stakeholders. Candidate must have excellent problem-solving skills and be able to work in a fast-paced team environment.

The candidate should display excellent leadership skills, documentation skills and troubleshooting abilities. The candidate will document development activities accurately in research notebooks and paper/electronic batch records as per corporate guidelines and provide concise reports and updates to management as required.

The candidate will be expected to effectively complete day to day operations while managing data and communicating with external stakeholders.  The candidate will be expected to work closely with PD operations management, deliver detailed updates, and display sense of urgency while completing critical tasks. The candidate will be expected to provide solutions to help troubleshoot pilot scale operations and central service-related issues.

This role will occasionally require adjusted work schedules to meet operational demands.

Position is full-time, Monday - Friday. 8:00-5:00pm are the hours. Candidates currently living within a commutable distance of Lexington, MA are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options. The candidate may be asked to travel occasionally (domestically and internationally) for conferences, seminars, and project specific needs (approximately 5% travel).

•  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.