Scientist / Technical Project Manager

The Fountain Group; South San Francisco (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

A leading company in the biotech sector is seeking a Scientist / Technical Project Manager for their Analytical Chemistry Validation and Method Transfer Department. The role involves managing the validation lifecycle of quality control methods, project management, and ensuring regulatory compliance. Candidates with a BS, MS, or PhD in relevant fields and expertise in analytical chemistry are encouraged to apply. Projects include working with clinical portfolios and utilizing statistical tools for method evaluation. This position offers a competitive hourly rate with contract potential for extension.

Qualifications

• BS with 5+ years, MS with 3+, or PhD with 1+ years of experience.
• Good knowledge in analytical chemistry technologies.
• Proficient in QC assay development and cGMP.

Responsibilities

• Responsible for validation life cycle of quality control methods.
• Oversee project management activities across clinical product portfolio.
• Support authoring Analytical Method Validation documentation.

Skills

Analytical Chemistry

Project Management

Method Development

Validation

cGMP

Communication

Education

BS with 5+ years experience

MS with 3+ years experience

PhD with 1+ year experience

Tools

HPLC

CE

Job description

Job Title:Scientist / Technical Project Manager
Location:South San Francisco, CA
Pay: $60-79 hourly, depending on experience level
Onsite, M-F, 9-5pm, occasional remote days (remote 1-2 days per week)
6-month contract with potential for extension / conversion
Qualifications:

• BS with 5+, MS with 3+ or PhD with 1+ years of experience focusing on method development, validation and transfer and product management.
• Good knowledge in analytical chemistry across a wide range of technologies e.g., HPLC, CE, etc.
• Proficient knowledge and experience of QC assay development and validation, and cGMP.

Job Description:

• The Analytical Chemistry Validation and Method Transfer Department is responsible for the validation life cycle of quality control methods (covering a wide array of techniques) until established as part of a commercial control system.
• Project management activities to support partners with project leaders and team members to ensure proper and timely execution of all aspects of the clinical analytical method life cycle across Genentech’s clinical product portfolio and testing sites (including CMOs and partners).
• Evaluation of corporate and regulatory policies and coordination of activities for implementation of these policies.
• Support authoring the contents of Analytical Method Validation life cycle documentation (including master plans, protocols, test methods, and reports).
• Creates a project validation plan (i.e., timelines and resources) and provides status updates to management.
• Utilize statistical tools for evaluation of method validation and trending data.
• Additionally, the candidate is expected to identify, evaluate, and implement continuous business process improvements. Excellent communication and presentation skills are essential.