(Contract) Senior QC Scientist

Kymanox•Fairland, MD

About The Position

Kymanox is seeking a Senior QC Scientist to provide subject matter expertise and project support in CMC and pharmaceutical development, analytical sciences, quality control, stability, and product and process scale-up. The role includes project management, regulatory and technical writing, quality compliance support, equipment validation, analytical method development and validation, and GMP/GLP testing. The candidate will work across pharmaceutical, biotechnology, medical device, and combination product projects in a collaborative professional services environment.

Requirements

Bachelor’s degree in engineering or science, with coursework or work-related experience in GMP analytical expertise.
5 to 7 years of experience working in development and/or manufacturing in the pharmaceutical, biotechnology, combination product, and/or medical device sectors.
Demonstrated experience in the pharmaceutical, biotechnology, combination product, and/or medical device sectors.
Familiarity with risk management tools and applications and data analysis tools and applications.
Understanding of ISO 13485 and FDA’s QMSR.
Detail-oriented, with strong organizational, verbal, and written communication skills.
Highly motivated self-starter with a sense of ownership and willingness to learn.
Ability to thrive in a fast-paced, growing, and dynamic work environment and form partnerships with internal stakeholders.
Seasoned soft skills, including high emotional intelligence, and technology savvy.

Nice To Haves

Experience with pre-filled syringes, autoinjectors, co-packaged kits, other drug delivery platforms, and/or other combination product platforms.

Responsibilities

Provide subject matter expertise and direct support for CMC/pharmaceutical development, analytical sciences, quality control, stability, and product/process scale-up projects.
Perform project management for assigned CMC Services and Analytical Sciences projects.
Author, format, and review CMC and quality sections of IND, NDA, ANDA, and BLA regulatory submissions.
Author, format, and review protocols and reports covering analytical method validation and transfer, stability, technology transfer, risk management, and process qualification.
Validate equipment commissioned in a GMP environment.
Draft regulatory documents for biologics, small molecules, and drug-device combination products, including design history files (DHF), DHF remediation, and ICH/FDA process risk assessments.
Support quality compliance activities, including deviation investigations, change control coordination, and complaint investigations.
Support control system validation.
Develop HPLC assay, impurity, and reference standard methods for CDMO clients.
Conduct HPLC method validations and transfers.
Perform release and stability sample testing for internally manufactured and client-provided samples under GMP/GLP specifications.
Write reports, SOPs, change controls, and protocols for internal and external use.