Principal Scientist, Molecule Analytical Chemistry

Position: Principal Scientist, Small Molecule Analytical Chemistry
** Job Description*
* We aspire to be the premier research-intensive biopharmaceutical company. At our company, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

We are seeking a Principal Scientist to join our Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) at our Rahway, NJ and West Point, PA sites. This is an exciting opportunity to lead a highly collaborative team of scientists utilizing innovative analytical characterization technologies to drive late-stage small molecule pharmaceutical drug product development and commercialization.

The Principal Scientist responsibilities include, but not limited to, analytical method development and validation, 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 responses to regulatory questions.

The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. Effective interaction with other technical, regulatory, research and manufacturing groups is critical. The incumbent is required to work with teams to effectively coordinate drug product development efforts and lead the progress for multiple projects. The incumbent is also expected to mentor other scientists as well as build/maintain the scientific capabilities of our organization.

** Responsibilities*
* + Lead a team of scientists in analytical method development and validation, drug product testing, and analytical investigations in a cGMP environment.

+ Oversee drug product and manufacturing process characterization, stability studies, and specification development.

+ Support manufacturing process scale-up and validation.

+ Prepare Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions and respond to regulatory questions.

+ Collaborate effectively with technical, regulatory, research, and manufacturing groups.

+ Coordinate drug product development efforts and lead progress for multiple projects.

+ Mentor other scientists and build/maintain the scientific capabilities of our organization.

** Qualifications*
* _Required_

+ PhD in Analytical Chemistry or related discipline with seven or more (7+) years of relevant small molecule pharmaceutical development experience;  
** OR
* * MS with ten or more (10+) years.

+ Strong background and extensive hands-on experience with common analytical techniques such as Ultrahigh/High-Performance Liquid Chromatography (UHPLC/HPLC), Dissolution, Gas Chromatography, Ultraviolet (UV) and Infrared (IR) spectroscopy, and Karl Fischer titration.

+ Extensive experience with method development and validation.

+ Significant experience authoring relevant CTD sections of regulatory submissions (IND, NDA, MAA, JNDA, etc.).

+ 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.

+ Experience in mentoring and leading teams.

+ Significant experience in analytical technology transfers.

+ Demonstrated effective planning and execution of regulatory strategies.

_Preferred_

+

Experience with hyphenated analytical techniques such as LC/MS and GC/MS with proven ability in troubleshooting these methodologies.

*
* Required Skills:

*
* Academic Presentations, Bioconjugation, Computational Chemistry, Creativity, Data Analysis, High-Throughput Experimentation (HTE), Organic Synthesis, Professional Networking, Project Leadership, Research Proposal Development, Scientific Leadership, Scientific Literature Search, Strategic Thinking, Structure Based Drug Design, Synthetic Chemistry

** Preferred

Skills:

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* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  ()  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all…