Job Details

Qc Scientist

Join a dynamic and mission-driven organization at the forefront of innovation in drug product and medical device development. This is a great opportunity for a QC Chemistry Scientist to support GMP manufacturing efforts, particularly within the exciting field of nanomedicine!

Job Title: QC Scientist

Location: Onsite San Diego, CA

Salary: $90,000 - 95,000

Duration: 6-Month Contract-to-Hire

Key Responsibilities:

• Write and review study protocols and technical documentation
• Perform analytical data review to ensure compliance with regulatory and quality standards
• Manage and execute stability studies
• Support Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, including troubleshooting and root cause analysis
• Coordinate analytical method transfers and validation with external subcontractors
• Manage relationships with subcontractors to ensure timelines and quality expectations are met
• Contribute to continuous improvement and day-to-day operations within the QC department
• Report directly to the CMC Expert Manager

Qualifications:

• Master's degree in Chemistry (Bac+5); background in nanomedicine is a strong plus
• Minimum of 3 years of QC experience in a biotech or pharmaceutical GMP environment
• Prior experience in a QA department is advantageous, method validation
• Hands-on expertise with techniques such as HPLC, GC, and Karl Fischer titration
• Strong working knowledge of GMP regulations and guidelines (e.g., BPF, ICH-Q7, ISO 13485, US/EU Pharmacopeia)
• Proven project management skills and ability to meet ambitious milestones
• Detail-oriented with a strong sense of urgency and accountability
• Team player with excellent communication skills and a passion for quality-driven science

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.