Massachusetts Jobs

Research Associate/Sr. Research Associate, QC Virology

Location: Greater Boston area

Position Summary

Join a growing biopharmaceutical company as they develop and commercialize novel therapies and advance the field of gene therapy! Reporting to the Associate Director, QC Virology, the Research Associate or Sr. Research Associate - QC Virology will support the client’s portfolio of clinical development programs to ensure timely delivery of clinical supplies.

The Research Associate or Sr. Research Scientist - QC Virology will assemble, review and trend GMP and stability data, generating reports as necessary to document these activities. The incumbent will also support the development and implementation of GMP quality systems to ensure that the client is in compliance with US and international regulations, laws, and guidelines that oversee the manufacturing and testing of investigational clinical trial materials by authoring appropriate SOPs and implementing training programs to support QC and related GXP processes.

Responsibilities

• Support the development, technical transfer and validation of cell based viral assays.

• Conduct routine cell culture for viral assays and generation of cell banks

• Perform cell based viral assays to generate characterization, release and stability data

• Work independently to review and trend QC data, generating stability and other trending reports as necessary

• Prepare, analyze and trend QC data

• Support the development of QC systems and SOPs, to enable in-house QC release testing.

• Support QC deviations, investigations, analytical method performance trending and root cause analysis, change control and CAPA.

• Work with cross functional teams and support regulatory filing when needed.

Requirements

• BS or MS in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 2+ years industry experience

• Experience with routine cell culture and cell based infectious assays required, and experience with viral propagation strongly desired

• Experience performing biological assays in one of the following areas: immunoassays, cell-based assays, and microbiological assays

• Experience with statistical analysis of analytical data and stability studies preferred

• Experience with viral vectors is not required but experience with biologics preferred

• Familiarity with PCR methodology, in particular qPCR and/or ddPCR

• Ability and desire to work in a fast-paced, start-up environment

• Strong collaboration and team-working skills and be flexible.

• Independently motivated and detail-oriented with good problem solving ability

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.