Associate Principal Scientist, Supply Analytical Sciences (SAS)

MSD•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

Associate Principal Scientist We are currently seeking an exceptional individual for an Associate Principal 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 position is a scientific role in a fast-paced, multidisciplinary team environment. The successful candidate will be joining a group of innovative analytical scientists with broad deliverables to support commercial pharmaceutical products ensuring undisrupted supply of our company products to patients globally. The incumbent is expected to interact closely with internal sites and external partners in our Company network in identifying issues/gaps and implementing solutions, providing strong analytical support such as troubleshooting laboratory test methods and workflows as well as material for ensuring compliant, robust, and responsive supply. The individual will have a deep understanding of the global regulatory and business environment and the needs related to pharmaceutical drug substance and drug product development, GMP compliance in commercial manufacturing and data integrity.

Requirements

Bachelor’s Degree in Chemistry or related discipline with at least ten (10) years of relevant pharmaceutical development experience, OR Master’s Degree in Chemistry or related discipline with at least eight (8) years of relevant experience, OR PhD in Analytical Chemistry or related discipline with at least four (4) years of relevant experience
Strong analytical chemistry knowledge and extensive experience in analytical development
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 influence team direction for complex situations and navigate ambiguity
Ability to quickly adapt to changes and develop appropriate plans for managing risks
Strategic thinking and ability to articulate the “big” picture along with demonstrated ability in asking the right questions to drive critical conversations
Accountability
Accountability
Adaptability
Analytical Chemistry
Analytical Development
Bioanalysis
Biochemical Analysis
cGMP Regulations
Chemical Biology
Chemical Synthesis
Chemistry
Clinical Judgment
Computational Chemistry
Cross-Cultural Awareness
Data Analysis
Data Integrity
Deep Learning
Drug Development
Enzymology
Experimental Development
GMP Compliance
Interdisciplinary Collaboration
Investigation Procedures
IT Leadership
Laboratory Investigations

Nice To Haves

Working knowledge of pharmaceutical drug substance and/or drug product development and commercialization
Working knowledge of CMC filing requirements and regulatory guidances (e.g., ICH) for drug substance and/or drug product
Working knowledge of GMP and data integrity and recent industry trends in commercial production space

Responsibilities

Lead and/or execute analytical method development, improvement, validation and/or transfer activities
Author analytical procedures and/or methods development and validation protocols, technical reports, experimental designs, regulatory submission documents, etc.
Lead and/or perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs
Provide documentation/technical input during inspections and audits (Regulatory and Internal)