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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. 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, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
This position provides technical leadership and is a primary point of contact for CMOs (Contract Manufacturing Organizations) for PSS Client. The role is involved in the collaborative development of products for the client division and works directly to provide guidance for CMO groups that are supporting client products. This position is focused on global product development through commercial launch.
The role oversees and manages the tech transfer and scale-up of sterile injectable (includes solutions, lyophilized products, suspensions and emulsions) and ophthalmic pharmaceutical dosage forms (includes solutions, suspensions) and must have a fundamental understanding of cGMP, sterile operations, etc.
The individual will be expected to provide detailed technical, process understanding and expertise in support of complex technical investigations, process troubleshooting, technical transfer, scale up, as well as engineering and exhibit batch manufacturing. The individual will be instrumental in facilitating project and technical ownership to client prior to process validation/commercial batch manufacturing.
The individual will be expected to leverage collaboration across multiple groups and competing priorities and should have extensive understanding and experience dealing with large technical group of engineers, scientist and technicians in large multi-product contract manufacturing facilities. The role serves as the operations point of contact for technology transfer and manufacturing and should be knowledgeable of the documentation necessary for tech transfer of new products, including tech transfer plans and risk assessments.
- B.S. and 5 – 7 years of drug development/tech transfer/manufacturing experience or M.S. or Ph.D. and 2 – 3 years of drug development/tech transfer/manufacturing experience. Preferred education background in Pharmaceutics, Engineering or similar discipline, however, extensive experience with tech transfer processes may be substituted for education.
- Significant experience with tech transfer of drug products in or out of manufacturing sites
- Self-driven and self-motivated
- Excellent communication skills
- Track record of responsibility for multiple development projects
- Working knowledge of project management concepts and tools
- Working knowledge of Computer Aided Design (CAD) and/or Visio tools for Equipment/Process design
- Working knowledge of DOE and MiniTab tools for experimental design and data analysis.
- Significant experience in process development and scale-up
- Experience fostering relationships with CMOs
- Detailed knowledge of technology transfer and scale up.
- Ability to trouble shoot/recommend the solutions to resolve the technical issues with manufacturing equipment.
- Ability to handle multiple projects simultaneously at different CMOs.
- Ability to travel globally, up to 30 % to CMOs for technical meetings, technology transfer, demonstration /engineering / exhibit batches.
- Experience authoring, reviewing, and/or approving site technology documents such as tech transfer plans, risk assessments, validation protocols, reports, batch records, sampling protocols, CAPAs, change controls, procedures, policy and instructions, etc.
- Experience collaborating with R & D colleagues for required process development and analytical support needed to address process issues and solutions.
- Experience participating as needed in reviewing/authoring relevant regulatory and/or technical documents in support of implemented technologies or changes in the manufacturing process and evaluate the impact on the quality of the product
- Requires understanding of scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on sterile injectable pharmaceutical dosage forms.
- Experience participating in cross-functional teams in the evaluation and implementation of novel manufacturing technology and processes in commercial processes that increase process robustness and promote a culture of innovation and continuous improvement.
- Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, Monday – Friday 8:00am – 5:00pm. Candidates currently living within a commutable distance of Lake Forest, IL 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.
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