Senior CMC Scientist

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.
• 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).

Requirements

• The ideal candidate will have a bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline is required.
• An advanced degree (M.S. or Ph.D.) is a plus.
• 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.
• 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.

Qualifications

• Detail-oriented
• Strong organizational skills and verbal/written communication skills
• Highly motivated self-starter with a sense of ownership and willingness to learn
• Thrives 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

Skills

• Hands-on analytical chemistry expertise, including chromatography (HPLC with UV and ELSD detection)
• Expertise in compendial and physicochemical testing, including viscosity, osmolality, pH, and particle sizing
• Demonstrated formulation development experience in one or more routes of administration
• Experience with parenteral, nasal, and/or pulmonary formulation and analytical development
• Experience with combination products such as pre-filled syringes, autoinjectors, nasal devices, and pulmonary devices
• Experience with CMC processes, including batch manufacturing, release testing, and validation/qualification
• Experience with Lean Laboratory principles, instrument maintenance, and laboratory safety
• Experience providing analytical chemistry consulting or client-facing technical services

Benefits

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

About Kymanox

Kymanox is a life sciences professional services company dedicated to helping life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible. Founded in 2004, Kymanox has grown steadily since its inception and provides professional services related to engineering, compliance, and project management. The company services clients ranging from Fortune 100 companies to virtual start-up companies and is headquartered in Research Triangle Park, NC.