Quality & Regulatory

QA Manager - CMC Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 16074 Direct Hire MA

< Previous Job Back to List Next Job >

Our client is a mid-sized public company with approved product already on market.  Located in the suburbs of Boston & Cambridge, they are growing their in-house QA CMC team and are seeking a QA professional with experience in quality systems and/or quality operations in a cGXP biopharmaceutical environment (biologic or small molecule experience welcome).

The main function of this role is to support internal Quality Systems and external vendor management. You will be GMP focused for Phase I-Phase III drug substance and drug product development. 

Responsibilities include but are not limited to;
• Serve as a Quality Assurance Operations SME and representative for given drug substance or drug product initiatives and support method transfer, batch record review & product disposition, and implementation and/or compliance with internal quality systems.  
• Support release activities by review of batch documentation, testing and stability data.   
• Provide Cold Chain Break disposition for Clinical Trial Material. 
• Manage, incorporate and maintain Quality Agreements with external vendors and aid in the administration of the GMP Vendor Management Program.  Provide external auditor support; participate in all audit activities from audit scheduling, preparation, and audit closeout. 
• Support and enhance Inspection Readiness initiatives. 
• Provide QA CMC authoring and editing support for IND and IMPD filings.  

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have 5+ years of experience with quality systems and/or quality operations in a cGXP biopharmaceutical environment (biologic or small molecule experience welcome). BS degree or higher in a life sciences preferred but not required to be considered. Must have understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.  Preference to those with comprehensive knowledge of quality systems and drug development within an early to later stage pharmaceutical environment.      

Must be authorized to work in the US indefinitely to be considered and must be commutable to the 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

Apply with LinkedIn
Get hired faster
Apply

Job ID: 16058 Direct Hire MA

< Previous Job Back to List Next Job >

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.

Responsibilities

  • 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

Requirements

  • 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

Sr. Research Associate, QC Analytical - Virology Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 16057 Direct Hire MA

< Previous Job Back to List Next Job >

Our growing Gene Therapy client is looking to bring on board a Sr. Research Associate/Scientist to their growing Quality Control Virology team!  This role will review and trend development, GMP and stability data, generating reports as necessary, support the development and implementation of GMP quality systems and assist with authoring appropriate SOPs and implementing training programs to support QC and related GXP processes.  Sr. RA/Scientist 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 and AdV analytical methods (TCID50, rcAAV, residual infectious Ad, and other methods as needed), support viral clearance studies and external laboratory testing and internal study protocol design, study report review and IND support as needed.  Will support successful technical transfer, method qualification, troubleshooting and routine GMP testing for cell based infectivity, and virus detection assays. Engaging with in-house teams and external QC test labs and CMOs, oversee and manage: QC data review, method validation activities, protocol review and report finalization.

Responsibilities:

  • Support the development, technical transfer and validation of cell based viral assays.
  • 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
  • Prepare stability reports
  • 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.
  • Work with cross functional teams

Requirements:

  • BS or MS in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 4+ years industry experience
  • Experience with viral propagation and cell based infectious assays required, and experience with routine cell culture strongly desired
  • Experience developing and qualifying biological methods in one of the following areas: immunoassays, cell-based assays, and microbiological assays 
  • Experience drafting protocols, data reports and QC/QA compliance documents
  • 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, in particular qPCR and/or ddPCR
  • Ability and desire to work in a fast-paced, start-up environment

Head of QC Microbiology Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 16055 Direct Hire MA

< Previous Job Back to List Next Job >

Our growing Gene Therapy client is looking to add a Head of QC Microbiology to their team!  This role will play an integral part of a new QC Lab build out at their Waltham, MA location!  This role will oversee, and support microbiology testing performed by Contract Manufacturing Organizations (CMOs) and Contract Research Organizations CROs) including testing for bioburden, mycoplasma/mycoplasmastasis, sterility, endotoxin and container closure integrity.   Additional responsibilities include review of Environmental Monitoring data from CMOs in collaboration with CMC Quality Assurance to provide additional assurance that manufacturing facilities are in compliance with industry and health authority standards.    The Head of QC Microbiology will also develop internal microbiology testing capabilities and work with key stakeholders to ensure that microbiology testing performed internally and at CMOs/CROs is in accordance with the initiation of later phase clinical programs with the ultimate objective of establishing a GMP-compliant microbiology program for commercial products.   Provide GMP QC guidance and oversight to support clinical programs including but not limited to microbiology release and suitability testing, speciation testing, risk analysis and validation studies.  Other responsibilities include but not limited to:

Responsibilities

  • Support and management of QC microbiology/safety testing at CROS/CMOs and internal laboratories.
  • Prepare, analyze and trend QC microbiology data.
  • Support the development of QC systems and SOPs for QC Microbiology programs.
  • Support QC deviations, investigations and work with external testing laboratories on investigation actions and root cause analysis.
  • Work with cross functional teams to drive these initiatives forward

Requirements

  • BS, MS or Ph.D. in Microbiology or a related discipline with 8+ years industry experience
  • Experience drafting protocols, data reports and QC/QA compliance documents required
  • Experience with safety testing and EM in the biopharmaceutical industry.
  • Experience with viral vectors is not required but experience with biologics preferred
  • Ability and desire to work in a fast-paced, start-up environment

Head of QC Chemistry Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 16054 Direct Hire MA

< Previous Job Back to List Next Job >

Our mid-size Gene Therapy client is expanding and adding a Head of QC Chemistry to their team!  This role will play an integral part in the build out of a new QC Lab at their Waltham, MA location!  Head of QC Chemistry will provide leadership, strategic thinking and oversight toward the establishment, management, growth and oversight of internal QC Chemistry capabilities.  In addition, they will work with subject matter experts and key stakeholders to build a QC Chemistry laboratory, qualify instrumentation, author SOPs that support release and stability and characterization testing for drug substance, drug product and some raw materials as needed.  Will oversee testing of various product quality attributes including but not limited to purity by SDS-PAGE/CE, enzyme activity by LC-MS, sub-visible particulates by DLS/MALS, spectroscopy methods and various compendial (USP/Ph. Eur) methods including appearance, pH and osmolality.  Head of QC Chemistry will also collaborate with key stakeholders on management of analytical method validation, transfer, and work with QC Operations to oversee and manage review of data that support release and programs.

Requirements:

  • BS or MS in Biochemistry Chemistry or a related discipline with 10+ years (BS/MS) relevant industry experience.
  • Experience working in Quality Control within Biopharmaceutical industry.
  • Experience working with external contract labs (CMOs, CROs) is a plus.
  • Ability and desire to work in a fast-paced, start-up environment
  • Strong collaboration and team-working skills.
  • Strong communication, interpersonal and organizational skills.

Head of QC Virology Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 16053 Direct Hire MA

< Previous Job Back to List Next Job >

Our growing Gene Therapy client is expanding and adding a Director, Virology QC to their team!  They are based in Cambridge, MA and the role will move out to the Waltham, MA area to help build out a new, state of the art lab!  This role will build, review and trend development, GMP and stability data, generating reports as necessary to document these activities.   The Director of QC will also support the development and implementation of GMP quality systems to ensure that company 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.  The Director of QC- Virology will specifically support the gene therapy program pipeline including but not limited to oversight and management of technical transfer, method qualification and/or validation and routine GMP testing of AAV vector and AdV analytical methods (qPCR, TCID50, and other methods as needed) and support viral clearance studies. The Director will manage external laboratory testing and internal study protocol design, study report review and IND support as needed.

Ensure successful technical transfer, method qualification, troubleshooting and routine GMP testing for qPCR, cell-based infectivity, and virus detection assays. Engaging with in-house teams and external QC test labs and CMOs, oversee and manage: QC data review, method validation activities, protocol review and report finalization.

Responsibilities

  • Oversee the development, technical transfer and validation of qPCR and cell based viral assays.
  • Support the development and management 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 work with external testing laboratories on investigation actions and root cause analysis.
  • Work with cross functional teams to drive these initiatives forward

Requirements

  • BS or MS or Ph.D. in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 8+ years industry experience
  • Experience developing and qualifying biological methods in one of the following areas: immunoassays, cell-based assays, QPCR assays, and microbiological assays 
  • Experience drafting protocols, data reports and QC/QA compliance documents required
  • Experience with statistical analysis of analytical data and stability studies preferred
  • Experience with viral vectors is not required but experience with biologics 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

QA Validation Leader Direct Hire MA

Apply with LinkedIn
Get hired faster
Apply

Job ID: 15967 Direct Hire MA

< Previous Job Back to List Next Job >

Our client is a large, global biopharmaceutical company with approved products on market and a large campus in Massachusetts.  Do you have a background in Process Validation in either clinical or commercial processes?  Are you interested in taking part in PPQ runs in 2019 and helping to launch products to treat rare diseases?  Have you made the transition to QA from Engineering and looking for your next career move along that path under a well-respected QA leader?  If so, contact me to schedule a time to discuss further. 

The main function of this role is to manage, develop and implement validation processes for equipment and/or process or control system validation.

Responsibilities include but are not limited to;
•  Schedule, plan and manage validation projects including: new facility planning and construction, equipment selections, acquisition, installation and use; facility/system/process improvements, modifications and additions; computer-based systems and software.
•  Oversight for the development of protocols, Validation Master Plans, and Validation Summary Packages.
•  Direct or participate in technical failure analysis of processes/product not meeting specifications, developing statistical process control programs, reporting on trends to reduce product/process variability.
•  Statistical analysis and design of experimental approaches to process development activities.
•  Coordinates activities of other departments as well as providing day to day guidance to the Validation staff.    

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher in Engineering or a related field and 8-12+ years of cGMP biopharmaceutical experience with at least 2+ years in a leadership role.  Must have experience with PPQ, process validation, and method/process transfers.  Preference given to those with experience in clinical and commercial products in a multi-product site.    

Must be authorized to work in the US indefinitely to be considered and must be commutable to the 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.