Assoc Prin. Scientist, Chemistry
About The Position
We are seeking a highly motivated and experienced Associate Principal Scientist to join the Analytical Supply Analytical Sciences – API Supply group. This dynamic, laboratory-based position offers the opportunity to work in a fast-paced, multidisciplinary team, focused on solving complex analytical challenges related to the development and validation of Active Pharmaceutical Ingredient (API) manufacturing processes. The focus will be on supporting in-line products as well as launch products. The ideal candidate will have a strong scientific background and will collaborate with both internal and external teams to ensure the successful commercialization of our innovative drug products. This role offers a unique opportunity to make a significant impact in the pharmaceutical industry, ensuring compliant, robust, and efficient supply of critical materials. The Supply Analytical Sciences – API Supply group has an Associate Principal Scientist position available at the Rahway, NJ site. The Associate Principal Scientist position is a laboratory-based scientific role in a fast-paced, multidisciplinary team environment. The role is tasked with solving high complexity analytical problems related to the development and validation of API manufacturing processes for the commercialization of our Company innovative drug products. The incumbent will be expected to interact closely with internal development partners and with internal and external sites in our Company manufacturing network in identifying, implementing, and troubleshooting laboratory test methods and workflows as well as materials for ensuring compliant, robust, and responsive supply. The individual will have a deep understanding of the regulatory and business environment and needs related to API development and commercial supply and provide critical analytical support to ensure the successful commercialization of API manufacturing processes.
Requirements
- Bachelor’s Degree in Chemistry or related discipline with ten (10) years of relevant pharmaceutical development experience; OR Master’s Degree in Chemistry or related discipline with five (5) years of relevant pharmaceutical development experience; OR Doctorate Degree in Chemistry or related discipline with two (2) years of relevant pharmaceutical development experience
- Strong chemistry knowledge
- Good Manufacturing Practice (GMP) experience
- Demonstrated problem solving ability including the ability to perform investigations with strong technical troubleshooting skills and to assist in developing/implementing CAPAs
- Experience with common analytical techniques such as chromatography, spectroscopy, and Karl Fischer
- Strong communication (verbal and written) and interpersonal skills
- Ability to quickly adapt to changes and develop appropriate plans for managing risks
- Accountability
- Adaptability
- Analytical Chemistry
- Analytical Development
- API Development
- Chemical Synthesis
- Commercialization
- Cross-Cultural Awareness
- Data Analysis
- Experimental Development
- Fast-Paced Environments
- GMP Compliance
- Interdisciplinary Collaboration
- Laboratory Testing
- Lead Optimization
- Manufacturing Processes
- Multidisciplinary Collaboration
- Pharmaceutical Development
- Pharmaceutical Management
- Professional Networking
- Risk Management
- Scientific Research
Nice To Haves
- Working knowledge of API development and commercialization
- Technical experience that includes LC-MS, GC-MS and/or ICP-MS.
- Working knowledge of CMC filing requirements and regulatory guidance's (e.g., ICH) for API
- Experience working with CMO’s and CRO’s
- Demonstration of working in cross-functional team
- Strong interpersonal skills including the ability and sensitivity to deal with different cultures
Responsibilities
- solving high complexity analytical problems related to the development and validation of API manufacturing processes
- identifying, implementing, and troubleshooting laboratory test methods and workflows as well as materials for ensuring compliant, robust, and responsive supply
- provide critical analytical support to ensure the successful commercialization of API manufacturing processes
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
