Senior CMC Scientist

Kymanox•Morrisville, NC

About The Position

Kymanox is seeking a Senior CMC Scientist to join their team. This role is for individuals who want to make a difference, have an impact, and enjoy influencing their day-to-day work. The ideal candidate will be motivated by working alongside subject matter experts who will foster learning and growth, driven by the belief that patients deserve better. Kymanox is a life sciences professional services company dedicated to helping life science products reach the market more quickly, affordably, and with the highest quality and safety standards. The company provides professional services related to engineering, compliance, and project management, serving a wide range of clients from Fortune 100 companies to virtual start-ups. Founded in 2004 and headquartered in Research Triangle Park, NC, Kymanox offers an outstanding opportunity for learning and career advancement within a growing organization.

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.

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
A passport is required for this job.

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).