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Analytical Development Lead – Drug Product

Develop and validate analytical methods for biopharmaceutical drug stability testing
Groton, Connecticut, United States
Senior
$80,000 – 92,000 USD / year
14 hours agoBe an early applicant
Eurofins

Eurofins

A global leader in bio-analytical testing, providing a wide range of services across food, pharmaceutical, environmental, and consumer product industries.

Analytical Development Lead – Drug Product

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

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.

If you're looking for a rewarding career, apply with us today!

Job Description

Work in a GLP or GMP environment with appropriate documentation and safety practices

Lead the development and execution of analytical strategies for new drug product candidates

Plan, direct, and review laboratory work, including method development, validation, and transfer

Design and interpret stability studies to understand degradation mechanisms and support shelf-life assignments.

Develop impurity control strategies aligned with regulatory expectations.

Collaborate with formulations, process and regulatory teams to ensure seamless pharmaceutical drug development

Collaborate with colleagues to identify appropriate analytical approaches, including use of computational predictive tools, modeling software and data visualization tools where appropriate

Critically review and interpret scientific data to derive clear conclusions and provide direction for future work

Mentor and guide junior scientists in analytical techniques and data interpretation.

Evaluate and implement new strategies as needed, e.g. working with external partners

Communicate results and conclusions through various media including presentations and technical reports

Author relevant sections of the quality modules of regulatory submissions

Qualifications

Ph.D. in Analytical Chemistry or related field, with 5-7+ years of pharmaceutical R&D experience, or B.S./M.S. with 15+ years of pharmaceutical R&D experience required

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

Proven expertise in a broad range of analytical techniques, e.g,. chromatography, mass spectrometry, dissolution, spectroscopy, NMR, and data analysis

Strong understanding of regulatory requirements and experience with regulatory filings

Experience with method transfer and working with external partners

Proficiency in scientific software, data systems, and modeling tools

Demonstrated leadership, problem-solving, and mentoring capabilities

Desired Qualifications:

Experience with mathematical modeling or coding

Candidates currently living within a commutable distance of Groton, CT are encouraged to apply

Additional Information

Position is full-time, Monday-Friday, 8:00 am - 5:00 pm.

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

#LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

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Analytical Development Lead – Drug Product
Groton, Connecticut, United States
$80,000 – 92,000 USD / year
Product
About Eurofins
A global leader in bio-analytical testing, providing a wide range of services across food, pharmaceutical, environmental, and consumer product industries.