Senior Scientist - Analytical Commercialization Technology (ACT)
About The Position
The Analytical Commercialization Technology (ACT) group is seeking a Senior Scientist at its Rahway, New Jersey, or West Point, Pennsylvania site. ACT is an R&D group responsible for analytical development of late-stage pharmaceutical products. The successful candidate will use innovative analytical characterization technologies to support pharmaceutical drug product development and commercialization. The role involves advanced analytical problem-solving; data analysis using statistical tools to support product development and characterization; development and validation of robust analytical methods; drug product testing and analytical investigations in a cGMP environment; and characterization of drug products and manufacturing processes. The Senior Scientist will also perform stability studies, develop specifications, support process scale-up and validation, prepare CMC documents for global regulatory submissions, and facilitate technology transfer for commercial manufacture. The position requires collaboration in a dynamic, integrated, multidisciplinary team environment.
Requirements
- PhD in Chemistry or a related discipline; no experience is required, or an MS in Analytical Chemistry or a related discipline with at least five years of relevant pharmaceutical development experience.
- Strong knowledge and hands-on experience in chemistry and common analytical techniques.
- Demonstrated problem-solving ability.
- Excellent verbal and written communication skills.
- Demonstrated creativity and strong interpersonal skills.
- Ability to work in a team environment with cross-functional interactions.
Nice To Haves
- Strong background and extensive hands-on experience with common analytical techniques such as UHPLC/HPLC, gas chromatography, UV and IR spectroscopy, Karl Fischer titration, and dissolution testing.
Responsibilities
- Use advanced analytical tools to solve problems.
- Analyze data for technical insights and trending.
- Develop and validate robust analytical methods.
- Conduct drug product testing and analytical investigations in a cGMP environment.
- Characterize drug products and manufacturing processes.
- Perform drug product stability studies.
- Develop specifications and support manufacturing process scale-up and validation.
- Prepare Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions.
- Facilitate technology transfer for commercial manufacture.
- Collaborate in a dynamic, integrated, multidisciplinary team environment.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
