Senior Scientist - Supply Analytical Sciences (SAS)

MSD•Rahway, NJ

3d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.