Quality & Regulatory

Lead the Particle ID lab! Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 15601 Direct Hire MA

< Previous Job Back to List Next Job >

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.

Head of QA Operations (Clinical Mfg QA) Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 15580 Direct Hire MA

< Previous Job Back to List Next Job >

QA leadership opportunity now available at one of the state's top biopharma campuses, producing commercial and clinical biologics.  Great opportunity to join an experienced QA Director and established team to develop robust, phase-appropriate Quality systems to support Phase I & Phase II drug substance programs. 

The main function of this role is to provide QA oversight of Raw Materials, Cell Banks, and New Product Introduction at sites north and west of Boston/Cambridge.  

Responsibilities include but are not limited to;
•  Dispositioning of raw materials, cell banks and clinical drug substance
•  Deviations, CAPAs, Change Control and other Quality System activities
•  Support regulatory submissions and Inspection Readiness activities
•  Leadership and staff development of a team of QA professionals with a focus on Continuous Improvement

This is a brief summary of the role.  A formal description can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher with 8+ years relevant QA experience including leadership of QA teams.  Must have extensive experience with implementing phase appropriate controls to support early stage clinical manufacturing. 

Must be authorized to work in the US indefinitely to be considered.  This position will be base in the suburbs north and west of Boston and candidates must be able to commute to these locations.  Unfortunately, remote-based employees cannot be considered at this time.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

QC Sr. Manager, Biochemistry Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 15370 Direct Hire MA

< Previous Job Back to List Next Job >

QC leadership opportunity now available at one of the state's top biopharma campuses, producing commercial and clinical biologics.  Great opportunity to join an experienced QC Director and established team to support in-process, release and stability testing of biologic therapeutics.  

The main function of this role is to lead biochemistry laboratories performing a broad range of biochemistry-based QC techniques such as enzyme assays, PCR, SDS-PAGE, and compendial testing for both clinical and commercial products.   

Responsibilities include but are not limited to;
•  Provides leadership on a daily basis to ensure routine testing is performed in accordance with company goals and committments
•  Support method transfer and validation activities for commercial and clinical testing 
•  Introduction of new equipment and technology 
•  Identify and mitigate compliance risks and communicate with various projects teams

Formal descriptions and information on the company, hiring manager, etc. can be disclosed to interested candidates. 

Qualified candidates will have a BS degree or higher and 10+ years of industry experience in a cGMP QC setting supporting in-process, release and stability testing of biologic therapeutics.  Demonstrated experience leading large team is essential to be considered.  

Must be authorized to work in the US indefinitely to be considered and must be commutable to the suburbs of Boston & Cambridge or able to relocate with limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.