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Quality & Regulatory
Lead the Particle ID lab! Direct Hire MA
Job ID: 16155 Direct Hire MA
Our client is a large biopharmaceutical company in the suburbs of Boston/Cambridge with multiple approved products on market. They have built an in-house Particle ID lab to leverage state-of-the-art microscopy and spectroscopy tools
The main function of this role is to serve as a Technical Lead and perform identity testing for particles found in the GMP manufacturing of biologics. Analytical techniques in this group will include polarized light microscopy (PLM), Fourier Transform Infrared Spectroscopy (FTIR) and Rap.ID Spectroscopy (RAMAN + LIBS), Scanning Electron Microscopy (SEM), .
Responsibilities include but are not limited to;
• Prepare particles for microscopy techniques and determine characteristics of particles using PLM, FTIR and RAMAN.
• Trending of particles using historical data and review of data generated by junior staff
• Coach/mentor junior analysts concerning new lab techniques and serve as a technical resource in the particle ID laboratory.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS degree or higher in a relevant discipline and 5 - 7+ years industry experience in spectroscopy and microscopy as applied to particle identification processes (manufacturing/product contact studies/etc.).
The Hiring Manager has the flexibility to consider more experienced individual contributors as well, including PhD-level candidates. Preference given to those with GMP, LIMS and/or past experience with statistical software (ex: JMP, Statistica).
Must be authorized to work in the US indefinitely to be considered and must be commutable to the suburbs outside Boston & Cambridge area or able to relocate with very limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.
Sr. RA / Scientist, QC - PCR Direct Hire MA
Job ID: 16058 Direct Hire MA
Our growing Gene Therapy Client is looking to add a Sr. Research Associate / Scientist, Molecular Biology to their QC Virology team! This role will support the gene therapy program pipeline including but not limited to technical transfer, method qualification and/or validation and routine GMP testing of AAV vector analytical methods (qPCR, DD PCR, and other methods as needed) for lot release and stability. Also support external laboratory testing, internal study protocol design, study report review and IND support as needed and support technical transfer, method qualification, troubleshooting and routine GMP testing for molecular assays, including particle titer by qPCR or DD PCR, and residual DNA test methods. Engage with in-house teams and external QC test labs and CMOs to support QC data review, method validation, protocol review and report writing.
- Support the development, technical transfer and validation of molecular methods
- Support the development of QC specifications for in-process, release and stability testing programs
- Work independently to review and trend QC data, generating stability and other trending reports as necessary
- Prepare, analyze and trend QC data
- Prepare stability reports
- Support the development of QC systems and SOPs, such as sample management, shipping, release testing and laboratory investigations
- Support QC deviations, investigations, analytical method performance trending and root cause analysis.
- Work with cross functional teams
- BS or MS in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 4+ years industry experience
- Experience developing and qualifying PCR methods
- Experience drafting protocols, data reports and QC/QA compliance documents
- Experience with statistical analysis of analytical data and stability studies preferred
- Ability and desire to work in a fast-paced, start-up environment
- Strong collaboration, team-working skills and communication skills
- Independently motivated and detail-oriented with good problem-solving ability