Sr Research Associate, Analytical Ops

Descripción del trabajo

Job Responsibilities:

• Conducts method validation and transfer experiments with limited guidance for clinical and commercial drug substances and products.

• Conducts GMP testing for release and stability of clinical drug substances and products using various analytical techniques.

• Applies knowledge and complies with GMP in daily activities.

• Conducts GMP data review to ensure compliance with applicable Standard Operating Procedures (SOPs), test methods, specifications, and protocols.

• Performs regulatory filing analytical data verification to ensure data integrity.

• Conducts experiments for troubleshooting failures/investigations under supervision

• Authors and reviews analytical test methods

• Supports method transfer to qualify CMOs/CTLs for release and stability testing

• Assists in training QC analysts.

• Escalates issues and risks to the manager and stakeholders, as applicable.

Specific Education & Experience Requirements:
2+ years of experience with BA or BS degree in Chemistry or Biology.
MS in Chemistry or Biology with 0+ industry experience.

Knowledge and Skills:

• Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, GC, Dissolution, KF titration, Particle Size Distribution, etc.

• Excellent technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical environments.

• Strong working knowledge of cGMP and quality control (QC).

• Knowledge in Lab information System and Part 11 software (e.g. Empower, Electronic Lab Notebook, SDMS and LIMS) to ensure data integrity rules are followed and documentation are in compliance.

• Knowledge in Compliance System (e.g. GVault)

• Be an effective communicator of ideas and results to team members across cross-functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.

• Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience.

• Excellent verbal and written communication skills.