Associate Principal. Scientist, Chemistry

Merck•Upper Gwynedd Township, PA

14d•Hybrid

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, or West Point, PA, USA. The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from API and Drug Product analytical troubleshooting to drive lead-time reduction and efficiency gains in support of our company’s World Class Supplier and Operationalizing Quality goals. The Associate Principal Scientist position is a laboratory-based scientific track role in a fast-paced, multidisciplinary team environment. The incumbent will be expected to influence both internal partners as well as external sites in our Company’s world-wide Manufacturing network in identifying, implementing, and troubleshooting laboratory test methods to ensure robust supply of materials. The incumbent will: 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. The individual may also be responsible for technical training of staff, as needed, on analytical techniques and problem solving. Possess a strong technical background with excellent problem‑solving skills, solid leadership abilities, strong knowledge of cGMP and Data Integrity are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize Our Company’s World Class Supply vision.

Requirements

MS in Chemistry or related discipline with at least 8 years of relevant pharmaceutical development experience or PhD in Analytical Chemistry or related discipline with at least 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.
Advance knowledge of ALCOA+ principles.
Accountability
Adaptability
Analytical Chemistry
Analytical Development
API Development
Chemical Synthesis
Chromatography
Clinical Judgment
Data Analysis
Data Integrity
Experimental Development
Interdisciplinary Collaboration
Laboratory Techniques
Laboratory Testing
Lead Optimization
Organic Chemistry
Pharmaceutical Development
Professional Networking
Risk Management
Scientific Research
Synthetic Chemistry
Technical Leadership
Technical Training

Nice To Haves

Advance experience developing various analytical techniques (e.g., chromatography, and spectroscopy) and product specification to support drug substance development and registration.
Have a fundamental knowledge of synthetic (organic) chemistry.
Advance experience with API development and commercialization for an analytical perspective.
Advance experience working with contract manufacture organizations and/or contract research organizations.
Advance 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.
Technical training of staff, as needed, on analytical techniques and problem solving.