Extractables and Leachables Scientist

Eurofins Lancaster Laboratories Professional Scientific Services, LLC - Lake Forest, IL

Full-time
Extractables/Leachables Scientist

Employee Responsibilities:
This position will leads and plans analytical laboratory assignments and activities to meet established project goals and timelines. Provides extractable and leachables and impurity identification support in developing new products.

Assists in LC/MS or GC/MS method development and executes method validations and method transfers. This Scientist will designs and execute extractable and leachables studies per USP <1663> and <1664>, prepares and review technical documents, including protocols and reports, analytical test procedures, technical reports, and change controls. Provide the necessary documentation for regulatory submissions as required.

This position also ensures that the analytical procedures they develop, review or establish conform to current and appropriate scientific, compendial and regulatory standards, and are suitable for use for their intended purpose.

Assists in performing laboratory investigations. Work directly with parties beyond R&D, including but not limited to 3rd party analytical labs, Contract Manufacturing Organizations (CMO’s), and involvement with other divisions of client. Evaluates new or state-of-the-art technology for potential use for characterization and assessment of key drug product attributes and performs duties with a high level of independence.

The Ideal Candidate would possess:
Experience leading and planning analytical laboratory assignments and activities to meet established project goals and timelines.
Experience providing extractable and leachables and impurity identification support in developing new products.
Experience assisting in LC/MS or GC/MS method development and executing method validations and method transfers.
Experience designing and executing extractable and leachables studies per USP <1663> and <1664>.
Experience preparing and reviewing technical documents, including protocols and reports, analytical test procedures, technical reports, and change controls. Provide the necessary documentation for regulatory submissions as required.
Ensuring that the analytical procedures they develop, review or establish conform to current and appropriate scientific, compendial and regulatory standards, and are suitable for use for their intended purpose.
Experience assisting in performing laboratory investigations.
Experience working directly with parties beyond R&D, including but not limited to 3rd party analytical labs, Contract Manufacturing Organizations (CMO’s), and involvement with other divisions of client.
Experience evaluating new or state-of-the-art technology for potential use for characterization and assessment of key drug product attributes.
Experience performs duties with a high level of independence.

Minimum Qualifications:
Bachelor’s degree in the physical or biological sciences with 5 to 6 years of industry experience, MS with 3 to 4 years of industry experience or PhD degree with 1 to 2 years of industry experience.
Must have strong experience in extractables/leachables, chromatography and mass spectrometry (LC/MS, GC/MS).
Strong written and oral communication skills and the use of MS Office (Word, Excel) are required
Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
Authorization to work in the United States indefinitely without restriction or sponsorship

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 PSS is a global, award-winning insourcing solution 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 PSS, please explore our website www.eurofinsus.com .

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

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