Senior Scientist - Supply Analytical Sciences (SAS)

Merck•Rahway, NJ

9d•$117,000 - $184,200•Onsite

About The Position

The Senior Scientist is a laboratory-based scientific track role in Supply Analytical Sciences (SAS), within Analytical Chemistry in Development and Supply (ACDS), located in Rahway, New Jersey. The successful candidate will join a multidisciplinary team whose work includes analytical troubleshooting for active pharmaceutical ingredients (API) and drug products, reducing lead times, and improving efficiency. The position supports the company’s World Class Supplier and Operationalizing Quality goals, with a focus on analytical deliverables related to API and drug substance manufacture.

Requirements

Master of Science in Chemistry or a related discipline and at least eight years of relevant pharmaceutical development experience, or a Ph.D. in Analytical Chemistry or a related discipline and at least two 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 and flexibility to work in a dynamic environment, including internal and external communications.
Strong interpersonal skills, with flexibility and sensitivity when dealing with different cultures.
Self-motivated, with the ability to take ownership and accountability of issues and drive them to completion.
Ability to adapt quickly to changes and develop appropriate plans for managing risks.
Advanced knowledge of ALCOA+ principles.
Must be able to travel on the company’s behalf.

Nice To Haves

Advanced experience developing analytical techniques, such as chromatography and spectroscopy, and product specifications 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, and regulatory submission documents.
Conduct investigations and apply strong technical troubleshooting skills.
Provide documentation and technical input during regulatory and internal inspections and audits, and apply working knowledge of data integrity.
Evaluate analytical methods associated with critical quality attributes of cGMP materials.
Provide technical training to staff on analytical techniques and problem solving, as needed, once established within the department.