Senior Scientist, Supply Analytical Sciences - API Supply

Job Description

We are seeking a highly motivated and experienced Senior Scientist to join the Analytical Supply Analytical Sciences – API Supply group.  This dynamic, laboratory-based position offers the opportunity to work in a fast-paced, multidisciplinary team, focused on solving complex analytical challenges related to the development and validation of Active Pharmaceutical Ingredient (API) manufacturing processes. The focus will be on supporting in-line products as well as launch products. The ideal candidate will have a strong scientific background and will collaborate with both internal and external teams to ensure the successful commercialization of our innovative drug products. This role offers a unique opportunity to make a significant impact in the pharmaceutical industry, ensuring compliant, robust, and efficient supply of critical materials. The Supply Analytical Sciences – API Supply group has a Senior Scientist position available at the Rahway, NJ site. 

Job Function:

• The Senior Scientist position is a laboratory-based scientific role in a fast-paced, multidisciplinary team environment.
• The role is tasked with solving high complexity analytical problems related to the development and validation of API manufacturing processes for the commercialization of our Company innovative drug products. 
• The incumbent will be expected to interact closely with internal development partners and with internal and external sites in our Company manufacturing network in identifying, implementing, and troubleshooting laboratory test methods and workflows as well as materials for ensuring compliant, robust, and responsive supply.
• The individual will have a deep understanding of the regulatory and business environment and needs related to API development and commercial supply and provide critical analytical support to ensure the successful commercialization of API manufacturing processes.

Education Minimum Requirement and Experience:

• Bachelor’s Degree in Chemistry or related discipline with five (5) years of relevant pharmaceutical development experience; OR
• Master’s Degree in Chemistry or related discipline with three (3) years of relevant pharmaceutical development experience

Required Experience and Skills:

• Strong chemistry knowledge
• Good Manufacturing Practice (GMP) experience
• Demonstrated problem solving ability including the ability to perform investigations with strong technical troubleshooting skills and to assist in developing/implementing CAPAs 
• Experience with common analytical techniques such as chromatography, spectroscopy, and Karl Fischer
• Strong communication (verbal and written) and interpersonal skills
• Ability to quickly adapt to changes and develop appropriate plans for managing risks

Preferred Experience and Skills:

• Working knowledge of API development and commercialization
• Technical experience that includes LC-MS, GC-MS and/or ICP-MS.
• Working knowledge of CMC filing requirements and regulatory guidance's (e.g., ICH) for API
• Experience working with CMO’s and CRO’s
• Demonstration of working in cross-functional team
• Strong interpersonal skills including the ability and sensitivity to deal with different cultures

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, pr