SR. QC ANALYST (QC-009)

General Job Description/Team Overview:

As part of a talented and multi-disciplinary team advancing an exciting new approach to gene therapy drug discovery, development, and manufacturing, the successful candidate will support the QC operations and work in a laboratory environment under the direction of the QC Manager. The candidate will be setting up, validating, and executing assays for analysis and release of retroviral gene therapy products and raw materials. The position will involve working with analytical instrumentation (i.e., ddPCR, PCR, high-throughput automated fluorescence and luminescence systems, robotic nucleic acid and protein extraction system, FTIR, particle analyzer, osmometer), as well as a variety of chemical and biological assays, and reporting results. The candidate will interact with R&D, process development, production, quality, and technical teams, as well as contract labs on analytical testing projects. The level will be determined based upon the candidate’s education, skills, and/or related experience.

Primary Duties and Responsibilities (include but are not limited to):

· Perform assigned testing in a timely and organized manner in compliance with the applicable GLP, cGMP, safety, and environmental regulations, as well as company policies and procedures.

· Test raw materials, in-process samples, finished products, and validation and stability samples to ensure conformity to standards and specifications.

· Work with retroviral gene therapy products and associated assays (ddPCR, PCR, cell-based potency assays, virus infection, and proliferation assays, ELISA, kinetics, SDS PAGE, agarose gel, western blot, etc.).

· Lead analytical method development/optimization/qualification and stability study projects.

· Operate, calibrate, troubleshoot and maintain analytical equipment. Assist in laboratory equipment qualifications (IQ, OQ, PQ, and MQ).

· Serve as subject matter expert for assigned assays.

· Evaluate and implement new techniques and technologies.

· Draft Standard Operating Procedures (SOPs), analytical technical reports, method validation, and stability protocols and reports. Conduct literature searches to identify suitable methods.

· Train junior analysts in new procedures and basic to complex laboratory troubleshooting techniques.

· Support investigations to determine the root cause of deviations and out of specification/trend results and implement appropriate corrective and preventative actions in a timely manner.

· Maintain organized, accurate, and complete laboratory notebooks and records.

· Assist in general upkeep of laboratory and maintain a clean work environment.

· Perform other duties as assigned.

Required Qualifications:

· Bachelor’s or Master’s (preferred) degree in Chemistry, Biochemistry, Biological Sciences, or related field with a minimum of 4 to 6 years analytical laboratory experience in the industry (biotech/pharma company).

· Must be proficient in mammalian cell culture and aseptic techniques, cell-based assay, PCR, ELISA, gel electrophoresis, FTIR, and wet chemistry. Knowledge of retroviral gene therapy assays and techniques is a plus.

· Strong ability in troubleshooting and problem solving with methods and instrumentation.

· Familiar with current GLP/cGMP, FDA, ICH, USP, and ISO regulations and guidelines, laboratory documentation, safety, and environmental requirements.

· Time management skills to optimize the analysis process and perform multiple tasks at the same time.

· Advanced level of written and verbal communication skills with the ability to read technical procedures and governmental regulations and guidelines. Able to write reports, and required quality control documentation.

· Support quality and continuous improvement processes. Willing to complete continued education coursework, training, or certification in quality control laboratory skills to fulfill assigned duties, as necessary.

· Able to understand statistics and statistical software to interpret experimental results.

· Able to stand prolonged periods and lift 30 lbs.

· General knowledge of Federal and State regulatory requirements in a GxP environment.

· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

· Excellent organization skills with attention to detail and accurate record keeping.

· High degree of discretion dealing with confidential information.

· Ability and willingness to work flexible hours when needed.

· Demonstrated ability to work independently and in a team environment.

· Excellent written, verbal, and interpersonal communication skills.

· Eligible to work in the U.S.

Compensation Range: $80,000-$100,000

Job Type: Full-time