Sterile Drug Product Commercialization Support Scientist

Sterile Drug Product Commercialization Support Scientist

02 May 2024
Massachusetts, Worcester / central MA, 01601 Worcester / central MA USA

Sterile Drug Product Commercialization Support Scientist

Company DescriptionEurofins 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 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 DescriptionEmployee Responsibilities:

Executes drug product development and commercialization studies, new product introduction and process validation at the commercial site.

Designs and executers process characterization activities. Ensures appropriate design principles including DOE are used where applicable.

Authors protocols for studies, ensures appropriate design of experiment and sample size selections.

Responsible for sample submissions and tracking. Employs statistical tools and methods to analyze results.

Authors technical reports that can be used as a source of documentation for regulatory filing. Also writes or performs second-person review for high-quality CMC sections for regulatory submissions.

QualificationsThe Ideal Candidate would possess:

Experience with operation and maintenance of pilot-scale pharmaceutical processing equipment

Ability to manage laboratory inventory for experimental execution and facility/equipment maintenance

Strong scientific, computer, organizational, and documentation skills

Excellent interpersonal, communication (oral and written), and collaboration skills and attention to detail

Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

Ability to perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Knowledgeable of GMPs as applied to manufacturing of biologics and vaccines

Qualifications

Bachelor's/Master's degree in engineering, biomedical engineering, chemistry, biology, or related field

Previous liquid formulation experience, including aseptic technique skills

Authorization to work in the United States indefinitely without restriction or sponsorship

Additional InformationPosition is full-time with overtime as needed. Candidates currently living within a commutable distance ofWest Point, PAare 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 holidays

Eurofins Lancaster Laboratories Professional Scientific Services®(PSS) is a global, award-winning insourcing solu ion that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.To learn more about Eurofins Lancaster Laboratories, please explore our websitewww.eurofinsus.com.Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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