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AgFunder
Natick, MA, United States
Kula Bio is a leader in sustainable nitrogen solutions, helping farmers improve crop yield and reduce environmental impact. We are producing a cost-competitive biofertilizer that boosts a naturally occurring process to deposit meaningful amounts of nitrogen in the soil. We are seeking a hands-on Analytical Bio/Chemist with experience in Quality
Job Source: AgFunderEuropean Watch Company
Boston, MA, United States
Job Description Job Description We are a national and international retailer expanding our fulfillment center. We are seeking an individual who can play multiple roles on our team. We are looking for someone who can adaptively multitask and stay highly organized. Fulfillment All general fulfillment responsibilities Quality control products be
Job Source: European Watch CompanyKula Bio, Inc
Natick, MA, United States
Job Type Full-time Description Kula Bio is a leader in sustainable nitrogen solutions, helping farmers improve crop yield and reduce environmental impact. We are producing a cost-competitive biofertilizer that boosts a naturally occurring process to deposit meaningful amounts of nitrogen in the soil. We are seeking a hands-on Analytical Bio/Chem
Job Source: Kula Bio, IncCommonwealth Care Alliance
Boston
**Why This Role is Important to Us:** **Position Summary:** The Director, Quality & Control Assurance reports to the VP of Quality & Control Assurance is responsible for providing strategic leadership and oversight for the Quality & Control Assurance within CCA’s Compliance department. This position designs, continually matures, promotes, & develop
Job Source: Commonwealth Care AllianceSpyre Therapeutics
Boston, MA, United States
Director, Analytical Development & Quality Control Spyre Therapeutics (NASDAQ: SYRE) is a biotechnology company aiming to address the needs of the millions of people living with inflammatory bowel disease (IBD) by advancing potentially best-in-class long-acting antibodies, rational therapeutic combinations, and precision immunology approaches. Spy
Job Source: Spyre TherapeuticsCommonwealth Care Alliance Inc.
Boston, MA, United States
Director, Quality & Control Assurance (Remote) #24-321 Legal & Compliance Why This Role is Important to Us Position Summary: The Director, Quality & Control Assurance reports to the VP of Quality & Control Assurance is responsible for providing strategic leadership and oversight for the Quality & Control Assurance within CCA’s Compliance departme
Job Source: Commonwealth Care Alliance Inc.Vertex Pharmaceuticals
Boston, MA, United States
Associate Director, Quality Sterility Assurance and Aseptic Controls (Boston) page is loaded Associate Director, Quality Sterility Assurance and Aseptic Controls (Boston) Apply locations Boston, MA time type Full time posted on Posted 5 Days Ago job requisition id REQ-21267 Job Description GENERAL POSITION SUMM
Job Source: Vertex PharmaceuticalsVertex Pharmaceuticals, Inc
Boston, MA, United States
Job Description GENERAL POSITION SUMMARY The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing. This role will partn
Job Source: Vertex Pharmaceuticals, IncNatick, MA, United States
AffyImmune Therapeutics, a clinical stage biotechnology company focused on developing technologies that expand the utility and improve the safety and efficacy of cell-based immunotherapy for cancer, is seeking a Quality Control professional to help advance the use of CAR T cell therapy for solid tumors. As part of the Quality team, you will play a key role in overseeing and partnering with contract QC laboratories.
Reporting to the Vice President of Quality, you will join a small team at a dynamic startup. You will directly oversee activities at contract QC laboratories including data analysis, investigations, deviations, change controls, and corrective/preventive actions. You will also collaborate with internal Analytical Development and the CMC team to develop strategies for analytical method qualification, validation, stability programs, bridging studies, and comparability assessments.
Location: Natick, Massachusetts; or Remote
Responsibilities:
Quality Control Operations (75%)
Oversee QC testing at multiple contract laboratories; participate in day-to-day issue resolutions.
Lead OOS/OOT investigations; identification, implementation, and follow up of corrective/preventive actions.
Perform data analysis and propose product release specifications.
Lead method transfers, qualification, and validations. In collaboration with Analytical Development author/review method qualification / validation protocols and reports.
Lead GMP stability programs and shelf-life assignments.
Issue Certificate of Analysis in support of product release.
Ensure vendor QC test methods comply with Regulatory requirements and AffyImmune Quality Standards.
Author / review relevant section of regulatory filings.
Quality Control Systems Build (25%)
Assess gaps in internal QC systems and develop phase appropriate processes and procedures.
Develop and implement strategies for method qualification and validation.
Develop and implement strategies for GMP stability, bridging studies, and comparability assessments.
Contribute to critical starting materials risk mitigation plans.
Participate in qualification audits of contract QC laboratories.
Develop metrics and monitor the performance of contract QC laboratories and report trends to management.
Qualifications:
BS/MS in Bioanalytical Sciences with experience in cell therapy or related fields.
In-depth knowledge of relevant cell therapy analytics including Flow Cytometry, qPCR, ddPCR/dPCR, cell-based assays, sterility, and biological potency.
Minimum 8 years direct QC laboratory experience including routine testing, reference standards and reagents management, instrument calibration/maintenance regimen.
Demonstrated experience overseeing contract QC testing organizations.
Demonstrated success in analytical methods transfer, qualification, and validation.
Experience in contributing to Module 3 IND filings.
Excellent understanding of FDA, EMA, and ICH regulations and guidelines for Quality Control.
Ability to manage multiple activities in a fast-paced drug development environment.
Ability to interpret, summarize, and discern criticality of issues for escalation to management.
Strong work ethic, enthusiasm, eagerness to learn, and willingness to perform ad-hoc tasks.
Experience working with electronic systems (e.g., LIMS, Veeva) a plus.
Excellent written and verbal communication and data analysis skills.
Fill out the form below to submit your resume/CV and apply for this position!
AffyImmune Therapeutics Inc.
22 Strathmore Road,
Natick, MA, 01760
ph: (508) 654-3600
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Email Alert for Associate Director of Quality Control jobs in Natick, MA, United States
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