Principal Scientist, Small Molecule Analytical Chemistry

BioSpace; Rahway (NJ); On-site; USD 130,000 - 190,000; Full time

Job summary

BioSpace seeks a Principal Scientist to lead analytical method development and validation within the ACT group in ACSD at Rahway, NJ and West Point, PA. The role focuses on late-stage small molecule drug product development and commercialization, mentoring a team, and coordinating cross-functional regulatory activities.

The successful candidate will drive method transfer, regulatory documentation, and collaboration across technical, regulatory, research and manufacturing teams to ensure

Qualifications

• PhD in Analytical Chemistry or related discipline with seven or more years of relevant small molecule pharmaceutical development experience; OR MS with ten or more years.
• Strong background with UHPLC/HPLC, Dissolution, GC, UV/IR spectroscopy, and Karl Fischer titration.
• Experience with method development and validation and regulatory CTD submissions (IND, NDA, MAA, JNDA).
• Mentoring and leading teams; effective cross-functional collaboration.

Responsibilities

• Lead analytical method development and validation for drug products in a cGMP environment.
• Oversee drug product and manufacturing process characterization and stability studies.
• Prepare CMC documents for global regulatory submissions and respond to questions.
• Mentor scientists and build scientific capabilities within the organization.
• Coordinate development efforts across multi-project portfolios.

Education

PhD in Analytical Chemistry

Tools

UHPLC/HPLC

Dissolution

GC

UV/IR spectroscopy

Karl Fischer titration

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.

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

• 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.