Senior Manager/Associate Director, Quality Control
3 months ago
Senior Manager/Associate Director, Quality Control (QC)
A Third Rock Ventures Stealth NewCo is seeking a Senior Manager/Associate Director, Quality Control (QC) to join their growing, experienced, and collaborative CMC team. In this role you will lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein products across company’s pipeline. Successful candidates will be innovative, thrive in a startup environment and use their creative and imaginative problem-solving skills to help bring new products to patients.
Key Responsibilities
- Develop strategies and execute QC activities for all pipeline programs, including in-process/release/stability testing, specification justification and maintenance, and critical documentation
- Oversee CDMOs for phase-appropriate analytical method development, qualification, validation, and transfer for in-process testing, drug substance (DS) and drug product (DP) release and stability testing. Review qualification/validation protocols, test procedures, raw data, and technical reports.
- Manage GMP data of DS and DP batch release and stability programs, monitor trends, troubleshoot QC method performance, and investigate OOT/OOS
- Build and maintain a mature QC infrastructure, implementing procedures to support the development of therapeutic candidates in a GMP-compliant manner.
- Contribute to analytical regulatory strategies, author technical protocols, reports and relevant analytical sections for regulatory filings
- Manage reference standards and critical reagents qualification and inventory for multiple programs at CDMOs and third-party testing sites
- Work closely with CMC team and key personnel including Quality Assurance, Regulatory, and Project Management, and with external CDMO and Contract Testing Laboratories to execute QC activities according to program needs and participate in external lab due diligence visits and audits as needed
Qualifications
- Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry or related field) and 6-8+ years of analytical development & quality control experience with complex biologics, particularly Fc-fusion proteins and monoclonal antibodies from early to late-stage development (or equivalent combination of education and experience)
- Expertise/competence in analytical techniques for biologics such as HPLC, CE-SDS, icIEF spectroscopy, ELISA, cell-based bioassays etc. Strong bioassay experience is a plus.
- Experience managing/partnering with CDMOs and third-party testing sites to establish and generate GMP QC data
- Experience managing large analytical data sets including method transfer, qualification, validation, lot release, and stability.
- Experience authoring and reviewing analytical methods, technical reports, and regulatory filings.
- Knowledge and understanding of cGMP/ ICH/ FDA/ EU guidance and regulations
- Experience qualifying and managing reference standard and critical reagents to support QC testing
- Experience with statistical analysis and statistical software is a plus.
- Excellent interpersonal and communication skills and demonstrated ability to effectively collaborate across functional lines in a team-oriented environment.
- Ability to work independently and multi-task in a fast-paced organization
-
Senior Manager/Associate Director, Quality Control
3 months ago
Cambridge, United States Third Rock Ventures Full timeSenior Manager/Associate Director, Quality Control (QC)A Third Rock Ventures Stealth NewCo is seeking a Senior Manager/Associate Director, Quality Control (QC) to join their growing, experienced, and collaborative CMC team. In this role you will lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein...
-
Senior Manager/Associate Director, Quality Control
3 months ago
cambridge, United States Third Rock Ventures Full timeSenior Manager/Associate Director, Quality Control (QC)A Third Rock Ventures Stealth NewCo is seeking a Senior Manager/Associate Director, Quality Control (QC) to join their growing, experienced, and collaborative CMC team. In this role you will lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein...
-
Senior Manager/Associate Director, Quality Control
4 months ago
Cambridge, United States Third Rock Ventures Full timeSenior Manager/Associate Director, Quality Control (QC)A Third Rock Ventures Stealth NewCo is seeking a Senior Manager/Associate Director, Quality Control (QC) to join their growing, experienced, and collaborative CMC team. In this role you will lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein...
-
Senior Quality Control Manager
1 week ago
Cambridge, Massachusetts, United States Vericel Corporation Full timeAbout the RoleThe Senior Quality Control Analyst is responsible for performing routine and non-routine assays of in-process samples, finished drug product, and stability samples within the QC laboratory in accordance with SOPs for product release and validation.This role also participates in special projects, method development/transfers, and cleaning study...
-
Director of Quality Oversight
2 weeks ago
Cambridge, Massachusetts, United States Jobot Full timeWe are a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases. Our team is seeking an experienced Senior Director of Quality Assurance (GMP) to provide quality oversight of our clinical development programs and manufacturing.Responsibilities:Provide quality support and guidance for our CMC...
-
Quality Control Associate
1 week ago
Cambridge, Maryland, United States Food Lion Full timeCompany OverviewFood Lion is a supermarket chain committed to providing excellent customer service and offering a wide range of products at competitive prices.Job DescriptionAs a Quality Control Associate, you will be responsible for ensuring that all products sold in our stores meet our quality standards. This includes conducting regular audits and...
-
Senior Director, Quality Assurance
3 months ago
Cambridge, United States Jobot Full timeJob DescriptionJob DescriptionPublicly Traded + Equity + Annual Bonus + HybridThis Jobot Job is hosted by: Katie GriffithAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $220,000 - $260,000 per yearA bit about us:We are a publicly traded biotechnology company developing biologics to treat chronic...
-
Quality Control Analyst, Senior
1 day ago
Cambridge, United States Vericel Corporation Full timeJob DescriptionJob DescriptionThis role will be based in our Cambridge, MA location until our new state of the art facility located in Burlington, MA is ready.Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Control professional looking to join...
-
Senior Quality Control Specialist
1 week ago
Cambridge, Maryland, United States Interstate Corrpack LLC Full timeJob Description: Director of Quality ManagementOverviewWe are looking for a seasoned Director of Quality Management to lead our quality management program at Interstate Corrpack LLC in Cambridge, MD. As a key member of our leadership team, you will be responsible for developing and implementing strategies to improve quality performance, ensure regulatory...
-
Associate Director, Quality Assurance
1 month ago
Cambridge, United States Alnylam Full timeThis role is considered Hybrid. Responsibilities: This role is a member of the GVP QA team providing Quality oversight of Alnylam's global post-marketing pharmacovigilance system, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations, and application of Good Pharmacoepidemiology Practice...
-
Director, Quality Control
6 days ago
Cambridge, MA, United States Alnylam Pharmaceuticals Full time< This role is considered Hybrid.Job SummaryThe Director of Quality Control Technical Services (QCTS) is responsible for providing enterprise level leadership and support for all late phase clinical and commercial QC programs. This includes providing direct ownership over specifications, reference materials and stability whose respective programs will need...
-
IT Controls Senior Manager
1 week ago
Cambridge, Massachusetts, United States Experis Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Manager to lead our IT Controls program. The ideal candidate will have a strong background in internal auditing, IT governance, and leadership.The successful candidate will be responsible for designing, implementing, and managing a comprehensive IT controls program that aligns with our...
-
Cambridge, Massachusetts, United States Jobot Full timeAbout This RoleJob Summary:We are seeking a highly experienced Senior Director of Quality Assurance and Compliance to provide quality oversight of our clinical development programs and manufacturing. The ideal candidate will have expertise in biologics, specifically operational QA experience with monoclonal antibodies, and a strong background partnering with...
-
Head, Analytical Controls
4 weeks ago
Cambridge, United States Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Lead and...
-
Senior Manager, IT Controls Lead
1 week ago
Cambridge, Massachusetts, United States EverQuote Full timeAbout the RoleThe Senior Manager, IT Controls is a hybrid role based in Cambridge, MA that will report to the CIO and operate and manage a Sarbanes-Oxley (SOX) IT Controls program. This role will ensure complete and accurate review populations and validate the propriety of control execution.Key Responsibilities:Direct IT controls monitoring team and provide...
-
Associate Director, Data Management
1 day ago
Cambridge, United States Prometrika LLC Full timeJob DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...
-
Associate Director, Analytical Sciences
1 day ago
Cambridge, United States Lifelancer Full timeJob DescriptionJob DescriptionJob Title: Associate Director, Analytical SciencesJob Location: Cambridge, MA, USAJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelThe CompanyWith deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with...
-
Cambridge, United States Marengo Therapeutics, Inc. Full timeJob Type Full-time Description Title: Associate Director/Director Quality Assurance Operations Marengo Therapeutics is pioneering first-in-class therapeutics that activate the right immune response to promote lifelong protection against cancer. Marengo has uncovered a novel approach to T cell activation by targeting the Vß TCR chain to unleash rapid,...
-
Head, Analytical Controls
1 month ago
Cambridge, United States Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Quality Control Analyst
2 months ago
Cambridge, United States Proclinical Staffing Full timeQuality Control Analyst - Contract - Cambridge, MAProclinical is seeking a Quality Control Analyst for a contract role in Cambridge, MA. Primary Responsibilities:The successful candidate will be responsible for ensuring the completeness, consistency, and accuracy of regulatory filings, laboratory data, and reports. This role offers flexibility for remote...