Quality Systems Specialist Salary at New England Organ Bank BETA

The Director is responsible for leading a team in the successful manufacture of stem cells, driving performance, and establishing a culture that achieves operational excellence. Collaborate with business partners to ensure reliable, expandable, and consistent cells are produced in our GMP clean rooms. The Director of Manufacturing must ensure quality and compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices. Role and Responsibilities: Lead a GMP cell culture manufacturing team, focusing on operations enabling a high success rate and minimizing deviations Supervise activities and monitor performance of manufacturing team members, providing clear guidance and coaching and necessary Ensure clean room and manufacturing areas, team, and equipment are compliant to all GMP and regulatory requirements Ensure GMP training status for team members for readiness and compliance Investigate and resolve dev

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity. Position Summary: The Senior Director of Quality Control (QC) will be responsible for leading the Quality Control Unit at Ocular Therapeutix (OTX) as the Organization continues growing and expanding its clinical and commerci

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: Manufacturing Engineer (Solventum) 3M Health Care is now Solventum At Solventum, we enable b

JOB TITLE: Director, Quality Assurance DEPARTMENT: Quality Assurance DATE PREPARED: September 10, 2024 JOB SUMMARY: The Director of Quality Assurance at AVEO Oncology reports to the Vice President Quality Assurance and is responsible for Quality Operations at AVEO including quality strategic leadership and compliance activities related to the cGMP manufacture and release of AVEO products. This position requires a high level of expertise in the industry, ensuring that all processes align with US, EU, and other applicable regional regulations including ICH Guidelines. The Director will champion a culture of quality, ethics, and continuous improvement across the organization, driving key initiatives that enhance product life cycle management, quality, efficacy, and safety. The incumbent will take a lead role in evaluating deviations and major investigations and will be responsible for disposition of clinical and commercial drug product to multiple jurisdictions. The incumbent will work cl

Bachelor's degree in Engineering or Life Sciences. Minimum of 5+ years of Pharma manufacturing industry experience. Strong knowledge of biologics drug substance production, including Cell banking, plasmid production, and gene therapy BDS, Cell culture, chromatography, TFF (tangential flow filtration), and aseptic techniques. Proven experience with quality systems documentation, including Deviations, change controls, batch records, and technical reports. Demonstrated ability to work independently and deliver results with minimal supervision. Skilled in managing multiple competing priorities in a dynamic, fast-paced environment. Exceptional communication skills, both written and verbal. Project management or collaboration with CDMOs (Contract Development and Manufacturing Organizations).

COMPANY OVERVIEW AIRNA is a biotechnology company with a mission to transform lives, one RNA edit at a time. AIRNA is pioneering the discovery and development of RNA editing therapeutics to realize the therapeutic potential of base editing for patients with rare and common diseases. RNA editing modality is poised to lead the next generation of RNA therapeutics by bringing the precision of gene editing technology with a potent and safe medicine that can be conveniently re-dosed and manufactured. Our RESTORE+™ platform is based on groundbreaking research by academic co-founders Thorsten Stafforst (University of Tübingen) and Jin Billy Li (Stanford University), who were the first to elucidate a therapeutic approach for precise editing of RNA. AIRNA has received $90 million in Series A financing from world class venture capital firms, including Forbion and Arch Venture Partners, and is headquartered in Cambridge, MA with research operations in Tübingen, Germany. JOB DESCRIPTION The Directo

Job Description Job Description This 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 and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Quality Control Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve. POSITION SUMMARY The Senior Quality Control (QC) Analyst is responsible for performing routine and non-routine assays of in-process samples, finished drug product (DP), and stability samples within the QC laboratory in accordance with SOPs for

Job Description: Quality Control (QC) Technician – Biomedical Devices Location: Natick, Massachusetts Employment Type: Full-Time Experience Level: Mid-Level (2+ years of relevant experience) About the Role: We are seeking a skilled and detail-oriented Quality Control (QC) Technician to join our team in Natick, Massachusetts. The ideal candidate will have experience in quality control processes for FDA-regulated medical devices, particularly in the production of acellular tissue matrix products. This is an exciting opportunity to play a critical role in ensuring the quality and compliance of a product with over 20 years of successful commercial success, impacting lives worldwide. Key Responsibilities: Quality Control Operations: Conduct inspections and quality control tests on raw materials, in-process products, and finished goods to ensure compliance with FDA QMS regulations and ISO 13485 standards. Develop, document, and maintain QC procedures and protocols. Regulatory Compliance: Ens