Senior Scientist - Supply Analytical Sciences (SAS)

Our company is currently seeking an exceptional individual for a Senior Scientist position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization located in West Point, PA or Rahway, NJ. This is a laboratory-based scientific role in a fast-paced, multidisciplinary team environment.

The successful candidate will join a group of innovative analytical scientists with broad deliverables to support commercial pharmaceutical products, ensuring an undisrupted supply of our company products to patients globally. This role offers the opportunity to interact closely with internal sites and external partners within our company network, identifying issues, implementing solutions, and providing strong analytical support.

Responsibilities

• Support commercial pharmaceutical products to ensure undisrupted supply.
• Interact closely with internal sites and external partners to identify issues and implement solutions.
• Provide strong analytical support, including troubleshooting laboratory test methods and workflows.
• Ensure compliant, robust, and responsive supply of materials.
• Understand the global regulatory and business environment related to pharmaceutical API and Drug Product development.
• Ensure GMP compliance in commercial manufacturing and data integrity.

Do you have experience in Technical troubleshooting support?, Do you have a Bachelor's degree?, Required

• Bachelor's Degree (BS) in Chemistry or related discipline with at least seven (7) years of relevant pharmaceutical development experience, OR Master's Degree (MS) in Chemistry or related discipline with at least five (5) years of relevant pharmaceutical development experience, OR PhD in Analytical Chemistry or related discipline
• Strong chemistry knowledge
• Demonstrated problem-solving ability, including the ability to perform investigations with strong technical troubleshooting skills
• Experience with common analytical techniques such as chromatography, spectroscopy, dissolution, and Karl Fischer
• Strong communication (verbal and written) and interpersonal skills
• Demonstrated ability to work in an interdisciplinary team environment
• Ability to quickly adapt to changes and develop appropriate plans for managing risks

Preferred

• Working knowledge of pharmaceutical API and/or drug product development and commercialization
• Working knowledge of CMC filing requirements and regulatory guidances (e.g., ICH) for API and/or drug product
• Working knowledge of GMP and data integrity and recent industry trends in commercial production space
• Experience supporting regulatory inspections and internal audits as an analytical subject matter expert
• Experience working with CMOs and CROs
• Experience assisting in developing/implementing CAPAs
• Strong interpersonal skills, including the ability and sensitivity to deal with different cultures

Required Skills: Adaptability, Analytical Method Development, CAPA System, Chemical Proteomics, Chemical Synthesis, Chemometrics, Chromatography, Data-Driven Decision Making, Flow Cytometry, Mass Spectrometry Based Proteomics, Motivation Management, Process Analytical Technology (PAT), Protein Chromatography, Spectroscopy, Synthetic Biology

4.14.1 out of 5 stars Rahway, NJ $117,000 - $184,200 a year - Full-time, Pulled from the full job description

• 401(k)
• Health insurance
• Vision insurance
• Dental insurance
• Paid holidays, We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.