Job Description
We aspire to be the premier research-intensive biopharmaceutical company. Our company is at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.
The Analytical Commercialization Technology (ACT) group is seeking applicants for a Senior Scientist position available at the Rahway, NJ and West Point, PA sites. ACT is an R&D group responsible for analytical development of late-stage pharmaceutical products. The successful candidate will utilize innovative analytical characterization technologies to drive pharmaceutical drug product development and commercialization.
The Senior Scientist responsibilities include, but not limited to problem solving with the use of advanced analytical tools, data analysis with the use of statistical tools to drive product development and characterization, development and validation of robust analytical methods, drug product testing and analytical investigations in a cGMP environment, drug product and manufacturing process characterization, drug product stability studies, specification development, manufacturing process scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and technology transfer for commercial manufacture. The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment.
Responsibilities
Utilize advanced analytical tools for problem-solving
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, and multidisciplinary team environment
Qualifications
Required
PhD in Chemistry or related discipline with no experience required OR
Master of Science (MS) in Analytical Chemistry or related discipline with at least five (5) 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
Preferred
Strong background and extensive hands-on experience with common analytical techniques such as Ultrahigh/High-Performance Liquid Chromatography (UHPLC/HPLC), Gas Chromatography, Ultraviolet (UV) and Infrared (IR) spectroscopy, Karl Fischer titration, and dissolution testing
.
Required Skills:
Analytical Method Development, Chemical Proteomics, Chemical Synthesis, Chemometrics, Chromatography, Data-Driven Decision Making, Mass Spectrometry Based Proteomics, Method Validation, Motivation Management, Process Analytical Technology (PAT), Protein Chromatography, Spectroscopy, Synthetic Biology
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal…