Associate Director, Quality Control
2 weeks ago
Associate Director, Quality Control Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen’s pipeline. In addition, this position will be required to actively support the preparation of regulatory filings. Technical collaboration and integrated planning with PepGen’s internal CMC team and associated contract organizations are key success factors, along with experienced leadership for the completion of planned QC activities in accordance with agreed scope, timelines and budget. This is an exciting opportunity for the right individual to join the PepGen team at a time when significant growth is occurring. Responsibilities: Work with the PepGen CMC team to support the creation of the control strategy for peptides, oligos and peptide-oligo conjugates according to project goals and development stage. Lead and manage in-process, release, stability testing, etc. at CMOs/CTLs. Contribute to set specifications and reference standard qualification for raw materials, intermediates, DS and DP; Manage the inventory of qualified reference standards. Lead the stability design and manage stability programs. Oversee laboratory investigations and review investigation reports. Enable the timely completion of Quality System records associated with release and stability testing to improve reliability of test methods, facilitate change, and evaluate and prevent exceptions (change control, lab investigations, OOS, deviations, and CAPAs). Coach and mentor junior QC scientists in the group and help develop and expand the group in terms of technical expertise and bandwidth. Collaborate with CTLs/CROs/CMOs and other external partners stateside and in Europe & Asia. Lead QC related regulatory reports, submissions, and responses ensuring compliance with all applicable regulatory guidelines. Review and approve stability reports, analytical method validation protocols and reports. Assist in negotiation of third-party contracts. Work closely within AD/QC and with cross-function teams (DS, DP, QA, reg CMC) to initiate and streamline QC related processes. Requirements: Ph.D. in Chemistry or related area and >5 years’ or Masters degree and >9 years’ experience in quality control or relevant role. Proven track record moving projects from early development to commercialization as a QC lead. Experience with phase-appropriate method qualification, validation and transfer. HPLC, LC-MS or LC-MS/MS experience, preferably with synthetic peptides and oligonucleotides. Experience using statistical software (e.g., JMP) for setting specifications, stability data trending and establishment of shelf-life for late stage or commercial programs. Working knowledge of quality systems and domestic and international regulatory requirements. Demonstrate prototypical leadership skills, planning, and organizational capabilities. Effectively implement work plans cross-functionally. Documented experience working in cGMP environment. Experience with oversight of CTLs, and management of stability program. Experience conducting and leading audits is a plus. Ability to work in a Hybrid environment by being on-site Tuesday – Thursday. Embrace our core values of Research, Innovation, Integrity, and Responsibility. About the Team: We are a team of passionate and creative scientists committed to analytical development and quality control of innovative EDO platform. We value honest communication with an open mindset. We are looking to enhance our group with another collaborative team member who shares our values, excitement about the possibilities our EDO platform offers and commitment to make a meaningful difference for patients. About PepGen: PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit www.pepgen.com or follow PepGen on Twitter and LinkedIn. #J-18808-Ljbffr
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Associate Director, Quality Control
2 months ago
boston, United States PepGen Full timeReporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen’s pipeline. In addition, this position will be required to actively support the preparation of regulatory filings. Technical collaboration and...
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Associate Director, Quality Control
1 month ago
Boston, United States PepGen Full timeReporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen’s pipeline. In addition, this position will be required to actively support the preparation of regulatory filings. Technical collaboration and...
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Associate Director, Quality Control
4 weeks ago
Boston, United States PepGen Full timeReporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen’s pipeline. In addition, this position will be required to actively support the preparation of regulatory filings. Technical collaboration and...
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Associate Director, Quality Control
3 months ago
Boston, United States PepGen Full timeReporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen’s pipeline. In addition, this position will be required to actively support the preparation of regulatory filings. Technical collaboration and...
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Senior Quality Control Director
3 weeks ago
Boston, Massachusetts, United States Praxis Precision Medicines Full timeJob SummaryWe are seeking a highly experienced Quality Control professional to join our team as Associate Director, Quality Control. This role will be responsible for managing and executing Quality Control activities in support of product testing, release, and stability, as well as toxicology studies test material inventory support.Key ResponsibilitiesManage...
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Boston, Massachusetts, United States Vertex Full timeJob Title: Associate Director, Chemistry Manufacturing ControlsJob Summary:The Associate Director, Chemistry Manufacturing Controls, plays a critical role in executing global regulatory CMC strategies for investigational and marketed products. This position leads the preparation and filing of regulatory CMC submissions and manages interactions with Health...
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2 weeks ago
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Quality Control Manager
5 months ago
Boston, United States North Coast Seafoods Full timeThe Quality Control Manager is responsible for managing all the quality aspects of their production facility and ensuring that all seafood products are manufactured in compliance with specific company Food Safety and QA requirements. They will manage a team of Quality Control Associates and Supervisors while working with production leadership to ensure...
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Boston, Massachusetts, United States Jobot Full timeJob DescriptionWe are seeking a highly experienced Senior Manager/Associate Director of Quality Operations to provide quality oversight for our biologics commercial programs.The ideal candidate will have a strong background in GMP quality and experience managing complex business relationships with QPs/EU business partners.Ensure CMO compliance with...
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Associate Director, Internal Controls
4 days ago
Boston, United States Servier Group Full timeServier is a privately held leader in oncology dedicated to bringing the promise of tomorrow to the patients we serve.Launched by Servier Group, a unique global organization operating in more than 150 countries and governed by a non-profit foundation, Servier in the U.S. is a privately held Oncology leader and has the resources and network of an established...
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Boston, Massachusetts, United States BioSpace, Inc. Full timeJob DescriptionJob Title: Associate Director, Clinical Quality ComplianceCompany: BioSpace, Inc.Job Type: Full-timeAbout Us: At BioSpace, Inc., we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We foster an inclusive, collaborative workplace, in which our teams are united...
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Director of Quality
2 weeks ago
Boston, United States Jobot Full timeJob DescriptionJob DescriptionRare Disease Biotech Company Looking for Director of QualityThis Jobot Job is hosted by: Victoria CasalAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $165,000 - $210,000 per yearA bit about us:Rare Disease Biotech based in BostonWhy join us?Competitive Base Full Benefits PTO...
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Boston, Massachusetts, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking a highly experienced Associate Director, Clinical Quality Compliance to join our team. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and...
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Associate Director, Quality Operations
3 weeks ago
Boston, United States Jobot Full timeJob DescriptionJob DescriptionBonus + Equity + 401(k) + REMOTEThis Jobot Job is hosted by: Katie GriffithAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $160,000 - $185,000 per yearA bit about us:We are a rapidly growing biotherapeutics company with an approved drug on the market, leveraging scientific...
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Sr Manager/Associate Director, Quality Operations
2 months ago
Boston, United States Jobot Full timeJob DescriptionJob DescriptionBonus + Equity + 401(k) + REMOTEThis Jobot Job is hosted by: Katie GriffithAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $145,000 - $185,000 per yearA bit about us:We are a rapidly growing biotherapeutics company with an approved drug on the market, leveraging scientific...
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Boston, Massachusetts, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking an experienced Associate Director, Clinical Quality Compliance to join our team. In this role, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management.Key ResponsibilitiesProvide...
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Associate Executive Director
2 weeks ago
Boston, United States Roxbury YMCA Full timeAssociate Executive Director Under the direction of the Senior Executive Director, the Associate Executive Director is responsible on a daily basis for creating a transformative Y Experience for our members, program participants and employees at their branch as well as supporting branches within their operations group. Associate Executive Director must be...
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Director of Quality Assurance
2 months ago
Boston, United States AVEO Oncology Full timeJOB TITLE: Senior Director/ Director, Quality Assurance DEPARTMENT: Quality Assurance DATE PREPARED: September 10, 2024 JOB SUMMARY: The Senior Director/ 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...
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Associate Director, Quality Operations Lead
4 weeks ago
Boston, Massachusetts, United States Jobot Full timeJob SummaryWe are seeking an experienced Associate Director of Quality Operations to join our team at Jobot. In this role, you will be responsible for providing laboratory QA support for our biologics commercial and clinical development programs.Key ResponsibilitiesVendor management of contract laboratories, including routine external meetings, coordination...
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Director of Quality and Safety
1 month ago
Boston, United States Boston Medical Center Full timeThe Director for Quality and Safety for the Department of Obstetrics and Gynecology directs quality and safety efforts in both inpatient and ambulatory settings. The Director will report directly to the Department Chair and will collaborate with the Vice Chairs of Clinical Operations, DEI, and Research to optimize and oversee the quality and safety...
