CMC QA Associate: Gene Therapy & cGMP Expert
The Steely Group
The Steely Group is seeking a CMC QA Consultant to support cross-functional teams across PD, MSAT, CMC, Manufacturing and Regulatory Affairs to ensure quality and compliant controls for gene therapy programs. You will review batch records, deviations, tech transfers, and regulatory submissions, lead QA oversight of process validation and CMO/QMS activities, and ensure compliance with cGMP throughout development to commercialization. #J-18808-Ljbffr The Steely Group
- The CMC QA Consultant will report to the Director of... ...in place for assigned Gene Therapy programs, and working... ...and drug product meet cGMP regulatory requirements... ...studies and associated report Provide quality... ...(approximately 10%). Expert knowledge of cGMP compliance...SuggestedContract workLocal area
- ...provides quality assurance oversight across CMC development, Quality Control, Analytical... ...this role, you serve as a subject matter expert in GMP quality systems, CMC quality oversight... ..., tested, and released in accordance with cGMP requirements.• Partner with CMC, Technical...SuggestedFull timeContract workImmediate start
$100k - $115k
...Description Job Description The field of gene therapy is growing rapidly and Genezen is here to... ...manufacturing activities. Support cGMP manufacturing operations through administration... ...in batch disposition activities. QA support of drug product aseptic fill...SuggestedLive inVisa sponsorshipShift work- ...areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Job Responsibilities: The Quality Assurance Professional will work in the Internal QA team of Human Genetic Therapies Quality Assurance Department. Responsibilities...Suggested
$28.85 - $34 per hour
At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through... ...of intermediate and final product. Support projects as a QA resource. Identifies deficiencies and works with cross functional...SuggestedHourly payFor contractorsWork at officeMonday to FridayWeekend work- Vericel Corporation, a leader in advanced cell therapies, seeks a QA-focused professional for day-to-day batch record review, labeling, archiving, and final product inspection in our Burlington, MA facility. You'll gown into ISO 7 clean rooms and support release activities...RelocationWeekend work
$72k - $91.5k
...company developing and commercializing novel therapies for diseases with unmet need, with a... ...patients who need it most. Reporting to the Associate Director, Quality Control – Stability and... ..., Quality Control, Manufacturing, CMC, Validation, and Quality Systems. This...Contract workWork at office- ...QA Documentation Associate A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most... ...Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description The Quality Assurance Associate...
- A biopharmaceutical company in Cambridge, MA is seeking a Compliance Specialist to support projects and manufacturing execution. The role involves coordinating manufacturing projects, leading investigations, and ensuring compliance with Good Manufacturing Practices. Ideal...
- ...DescriptionDescriptionThe Quality Assurance Professional will work in the US External QA team responsible for Contract Manufacturing (CMO) and Contract... ...metrics, data, and deliverables. Experience with GMP programs in cGMP biotech and/or pharmaceutical environments. A minimum of 5 years...Contract workFlexible hours
$110k - $120k
...and potential of CRISPR gene editing to transform... ...ensuring compliance with FDA, cGMP, and international... ...role is part of a small QA team with opportunities... ...-in-class, one-time therapy designed to significantly... ...Editas products and the associated risk management control...Flexible hours$86.8k - $198k
Missile Defense Software Expert, SeniorThe Opportunity:As an expert in missile defense systems, your unique background inspires you to think bigger, push further, and ask questions others don’t. We need your extensive knowledge and skills to guide teams as they solve some...Full timeContract workPart timeWork at officeLocal areaRemote work- ...and RF communications.Job Overview:MIT Lincoln Laboratory is seeking an experienced Full Spectrum Cyber Capability and Operations Expert to join our Cyber Physical Systems group within the Cyber Security and Information Sciences Division. The ideal candidate will have...
- Anika in Bedford, MA is seeking a Senior Quality Assurance Specialist to provide QA oversight across CMC development, manufacturing, and supply chain. You will serve as a subject matter expert in GMP quality systems, regulatory readiness, and continuous improvement of QMS...
- ...pharmacologist, study director). • Demonstrated expertise across multiple modalities (e.g., small molecules, biotherapeutics, radioligand therapies) and their safety considerations. • Proven track record of direct interaction with global Health Authorities, including IND...Relocation package
$92.5k - $175.1k
Work Your Magic with us! Start your next chapter and join MilliporeSigma.Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with...Worldwide$107.9k - $161.9k
Work Location: Burlington, MassachusettsShift: NoDepartment: LS-CL-CD Financial SystemsRecruiter: Shelby Elizabeth BriggsThis information is for internals only. Please do not share outside of the organization.Your Role:An exceptional opportunity has arisen within our Life...Local areaImmediate start- ...care and performing pulmonary function tests while ensuring quality patient care. Candidates should have an accredited Respiratory Therapy education and preferably two years of acute care experience. Essential certifications include BLS, ACLS, PALS, and NRP. This position...
- ...respiratory care to critically ill patients, initiating and adjusting therapies, and collaborating with physicians and nurses to optimize patient outcomes. The ideal candidate will have an Associate's degree in Respiratory Therapy (Bachelor's preferred), current BLS, NBRC...
- ...Job Description Job Description We are looking for an experienced Looker / Look ML Expert to join a contract engagement. In this role, you will convert established reporting assets into scalable Looker solutions, helping the organization modernize how business insights...Contract workTemporary work
- ...radiopharmaceuticals. You will own process knowledge from clinical to commercial production and serve as SME, interfacing with operations, Quality, and CMC/Radiochemistry. You will drive process characterization, equipment qualification, tech transfer, CAPA, investigations, and continuous...
- ...QA Specialist Perform the QA review/approval of analytical... ...Analytical method procedures and associated change controls Method... ...activities Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as... ...with technical subject matter experts to resolve validation protocol...
- Bruker in Billerica, MA is seeking a General Ledger Accountant to support US entities and ensure timely close cycles. You will prepare journal entries, reconcile balance sheet accounts, analyze US GAAP reports, and assist with audits. The role requires collaboration with...
- Lantheus Medical Imaging, Inc. in Bedford, MA seeks a seasoned Document Control Senior Specialist to oversee the corporate document control program within Quality Systems and Compliance. You will manage lifecycle controls in eDMS TrackWise Digital, ensuring documents are...3 days per week
- The Broad Institute seeks a Clinical Genomics Specialist for the ClinGen team to lead expert panels, curate variant and gene-disease relationships, and mentor junior biocurators. You will train staff, contribute to ClinGen publications, and help develop tools for curation...
- ...Cambridge, MA. This hybrid role leads ClinGen curation efforts, mentors biocurators, and collaborates across ClinGen EPs to assess gene-disease validity. Start ASAP or by Oct 2026, with a 2-year commitment. Responsibilities include evaluating variants, supporting ClinVar...Immediate start
- ...Burlington, MA. This role involves managing investigations of workplace hazards, reviewing industrial hygiene data, and providing expert testimony in legal proceedings. Applicants should have a Bachelor's degree, 5+ years of experience, and required certifications. The...
$115k - $125k
Astrion is seeking a Senior Logistics Manager at Hanscom AFB, MA to lead logistics operations for the AFLCMC/HNA program. The role requires an active Secret clearance, US citizenship, and extensive DoD experience. Salary range $115,000 - $125,000 annually, full-time. You...Full time- ...of test results to assist in debugging and modification of software. • Plan, design, deploy, maintain and troubleshoot related to QA tools like Tricentis TOSCA and Impact Analysis/Live Compare tool for SAP. • Analysis of test results to ensure existing functionality...Contract workApprenticeshipLocal area
- ...conduct GMP compliance audits as directed. The QA Specialist will have oversight of and... ...preparation of Chemistry and Manufacturing Control (CMC) sections inclusive of data verification... ...Compliance Strategy. Maintain all associated tracking logs and files, as applicable...Contract work
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