Senior Scientist - Supply Analytical Sciences (SAS)

Our company is currently seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization located at Rahway, NJ, USA. The successful candidate will join a group of innovative scientists with broad deliverables ranging from API and Drug Product analytical troubleshooting to driving lead-time reduction and efficiency gains.

This role supports our company’s World Class Supplier and Operationalizing Quality goals. The Senior Scientist position is a laboratory-based scientific track role in a fast-paced, multidisciplinary team environment, focused on analytical deliverables associated with API/Drug Substance manufacture.

Responsibilities

• Author analytical procedures, development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.
• Perform investigations with strong technical troubleshooting skills.
• Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity.
• Evaluate analytical methods associated with the critical quality attributes of cGMP materials.
• Responsible for technical training of staff, as needed, on analytical techniques and problem solving once established within our department.

• Master of Science (MS) in Chemistry or related discipline with at least eight (8) years of relevant pharmaceutical development experience; PhD in Analytical Chemistry or related discipline with two or more (2+) years of experience.
• Working knowledge of analytical techniques used in commercial testing of raw materials, intermediates, and drug substances.
• Strong verbal and written communication skills as well as flexibility to work in a dynamic environment (internal and external communications).
• Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.
• Self-motivated to take ownership and accountability of issues and drive them to completion.
• Ability to quickly adapt to changes and develop appropriate plans for managing risks.
• Advanced knowledge of ALCOA+ principles.
• Must be able to travel on our company’s behalf.

Preferred

• Advanced experience developing various analytical techniques (e.g., chromatography, and spectroscopy) and product specification to support drug substance development and registration.
• Fundamental knowledge of synthetic (organic) chemistry.
• Advanced experience with API development and commercialization from an analytical perspective.
• Advanced experience working with contract manufacturing organizations and/or contract research organizations.
• Advanced experience working in cross-functional teams.

Required Skills: Adaptability, Adaptability, Analytical Analysis, Analytical Chemistry, Analytical Method Development, Analytical Testing, Analytical Thinking, Chemical Proteomics, Chemical Synthesis, Chemistry, Chemometrics, Chromatographic Analysis, Chromatography, Commercialization, Cross-Functional Project Management, Data-Driven Decision Making, Data Integrity, Design of Experiments (DOE), Drug Delivery, Drug Formulations, Flow Cytometry, Mass Spectrometry Based Proteomics, Motivation Management, Pharmaceutical Sciences, Problem Identification {+ 10 more}

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.