Technical Development Principal Scientist

R&D Partners is seeking to hire a Technical Development Principal Scientist in San Diego, CA.

Your main responsibilities as a Technical Development Principal Scientist:

• Develop or adapt analytical methods for cell therapy product release and characterization by designing and executing studies via design of experiment (DoE).
• Design and execute exploratory experiments to better understand and define CQAs and optimize current analytical methods.
• Independently research, plan and execute experiments and analyze data to determine next course of action and make recommendations to internal and inter departmental audiences.
• Perform risk and gap assessments for analytical methods and aim to enhance compliance and robustness.
• Execute routine laboratory experiments in collaboration with more junior technical staff to generate high quality data by following best practices of assay and instrument operations.

What we are looking for in a Technical Development Principal Scientist:

• Masters degree with 6-9+ years experience in analytical development, QC, technology transfer and method lifecycle management or Ph.D. degree in a relevant scientific discipline (e.g., Immunology, Molecular Biology Biochemistry, or related field) with 2+ years of industry experience.
• Expertise in flow cytometry and immunology analytical method development, method transfer to QC labs is required
• Proven leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies and method qualification/validation
• Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiments (DoE)
• Ability to interpret and apply ICH guidances, cGMP, USP, regulatory requirements and industry best practices for analytical method development, technology transfer, method qualification/validation and process development.

Why ChooseR&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance - PPO, HMO &
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Pay Scale:

$115,565 - $144,435 Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.r-dpartners.com/privacy-policy/