Jobs at Kymanox

• Writing technical documentation with minimal direction.
• Conducting laboratory testing and data analysis.

• + Provides immediate project supervision and leadership.

Participates in and supports a matrixed team environment with organization and detail-oriented initiatives.
Reviews and/or approves technically complex documentation to ensure compliance with relevant standards and regulations.
Completes gap assessments against industry regulations or standards.
Participates in regulatory body inspections or remediation efforts.
Follows policies or standard operating procedures to support internal or client projects.
May support supply chain and vendor management strategy or compliance activities.
Completes assigned training requirements (internal and external).
Understands, authors and reviews both the Combination Product Design History File and Risk Management File.
Understand and authors quality events such as CAPA, Deviations, OOS, Investigations and Complaints.
May provide technical project management and meeting facilitation.

• Develop technical documentation for drug substance and drug product manufacturing across multiple product modalities (e.g., small molecule, biologics, gene therapies) including SOPs, CMC regulatory filings, manufacturing records, technical reports, process validation and technology transfer documents.