Sr. QC Analyst- Biotech

This Jobot Job is hosted by: Juan Correa

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Salary: $90,000 - $110,000 per year

We develop innovative gene therapies to treat cancer and prolong patient survival.

We synergistically kill tumors while activating the immune system to fight the patient’s cancer, combined with the integration of novel companion diagnostics positions us on the cutting edge of cancer immunotherapies and emerging clinical-stage cancer companies.

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance

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.

Job Description:

Senior QC Analyst

? 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.

Job Description:

Senior QC Analyst

? 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.

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