Senior CMC Scientist

Kymanox • Morrisville, NC

6d

About The Position

Kymanox is seeking a Senior CMC Scientist to join their team. This role involves making a difference in the lives of patients by working alongside subject matter experts in a dynamic and growing company. The ideal candidate is motivated by influencing their day-to-day work and contributing to the development of life-saving medicines.

Requirements

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline is required.
• 7+ years’ experience working in the pharmaceutical/drug, biotech/biologics, and/or combination product sectors is required.
• Hands-on analytical chemistry expertise, including chromatography (HPLC with UV and ELSD detection), is required.
• Expertise in compendial and physicochemical testing, including viscosity, osmolality, pH, and particle sizing, is required.
• Demonstrated formulation development experience in one or more routes of administration is required.
• A passport is required for this job.

Nice To Haves

• An advanced degree (M.S. or Ph.D.) is a plus.
• Experience with parenteral, nasal, and/or pulmonary formulation and analytical development is strongly desired.
• Experience with combination products such as pre-filled syringes, autoinjectors, nasal devices, and pulmonary devices is desired.
• Experience with CMC processes, including batch manufacturing, release testing, and validation/qualification, is desired.
• Experience with Lean Laboratory principles, instrument maintenance, and laboratory safety is desired.
• Experience providing analytical chemistry consulting or client-facing technical services is desired.
• Detail-oriented
• Strong organizational skills and verbal/written communication skills
• Highly motivated self-starter with a sense of ownership and willingness to learn
• Thrive in a fast-paced, growing, and dynamic work environment
• Ability to form partnerships with internal stakeholders
• Seasoned soft skills (i.e., high EQ)
• Technology savvy

Responsibilities

• Plans, designs, and executes laboratory formulation development activities across parenteral, nasal, pulmonary, and other routes of administration.
• Performs analytical development and testing, including chromatographic analysis by HPLC with UV and ELSD detection.
• Executes compendial and physicochemical testing, including viscosity, osmolality, pH, and particle size analysis.
• Develops, qualifies, and troubleshoots analytical methods in support of formulation and product characterization.
• Provides pharmaceutical consulting to clients in analytical chemistry and related CMC disciplines.
• Provides project leadership and support with supervision and guidance from managers as needed.
• Manages or provides oversight of third-party vendors (such as contract manufacturing organizations or analytical testing laboratories) as needed.
• Supports CMC activities such as batch manufacturing, release testing, and validation/qualification, as applicable.
• Maintains laboratory instrumentation and supports Lean Laboratory practices, instrument upkeep, and laboratory safety.
• Authors and reviews technically complex documentation, including protocols, methods, and reports, to ensure compliance with relevant standards and regulations.
• Participates in and supports a matrixed team environment with organized and detail-oriented initiatives.
• Follows policies or standard operating procedures to support internal or client projects.
• Completes assigned training requirements (internal and external).

Benefits

• Medical healthcare including dental and vision
• Short- and long-term disability
• Life insurance
• Matching 401(k) retirement plan
• Continuing education assistance
• Other benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior