This is an excellent opportunity to gain valuable experience with an innovative, small, young biotech company and build a career in the biopharmaceutical industry. Candidates should feel comfortable working in a high risk/potential, high reward environment and be able to work overtime and weekends as project needs are determined.

Responsibilities Include:

• Overseeing and maintaining quality control testing programs including method qualification, instrumentation maintenance, release/in-process/stability testing, control of reference standards, and critical reagents.
• Overseeing development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company methods and clinical products.
• Translating testing regulations, requirements, and guidelines into policies and practices that support GMP operations.
• Working with senior management to initiate and advance new projects. This includes analyzing product development plans for resource allocation and monitoring QC costs/expenditures.

• Scheduling and providing technical oversight of testing performed internally and via external contract testing laboratories/CMOs/CROs.

Minimum Qualifications:

• Bachelor’s/Master’s degree in life sciences
• 5+ years of experience with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

• Minimum of 1-year of experience managing one or more direct reports

• Hands on experience in protein analytics including HPLC, CE and/or immunoassays