Obsidian Therapeutics
  • About Us
    • Overview
    • Our Vision
    • Management Team
    • Board of Directors
    • Scientific Advisory Board
    • Investors
  • Our Science
    • Overview
    • Our Lead Program
    • Our Pipeline
    • cytoDRiVE® PLATFORM
    • Our Partners
    • Publications
  • News
  • Join Our Team
    • Overview
    • Our Culture
    • Testimonials
    • Benefits
    • Job Postings
  • Contact

Join Our Team

Back to Jobs

Director, GMP Quality

Bedford, MA

About Us…

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development. We recently received our IND clearance from FDA to begin our first clinical trial for the treatment of patients with metastatic melanoma.

We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our research team is based in the heart of Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in our brand new facility in Bedford, MA to support our growth.  Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity…

We’re looking for an individual with a strong background in Cell Therapy GMP manufacturing to contribute to building Obsidian’s Quality practice and team.  In this role, you’ll work collaboratively with internal and external stakeholders on CMC (internal) and CDMO/CMO (external) teams to assure phase appropriate Quality systems and processes are implemented.  As part of our Technical Development, Manufacturing, and Quality department, you’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program cytoTIL15 engineered to make TILs more effective for more patients.

This is a unique opportunity to be a contributor in a well-funded pre-clinical company with blue chip investors, field-leading advisors, best-in-class partners (BMS and Vertex), and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. 

You Will…

  • Partner with Sr. Director of Quality, Technical Development and Manufacturing, and Clinical Operations peers to strategically develop phase appropriate approach to quality assurance and quality assurance systems. This is initially an individual contributor role, with an expectation of future management responsibilities as the organization evolves and grows.
  • Be responsible for lot review/release activities for drug substances, drug products, and finished goods by Contract Manufacturing Organizations (CMOs).
  • Assure the company and its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and standards as well as regulations of applicable authorities.
  • Conduct clinical product release activities for drug substance, drug product, and /or finished goods for all phases of development including review and approval of Master Batch Records along with executed batch records.
  • Represent Obsidian QA on external CMOs’ project teams. Manage Quality to Quality relationship with CMOs, including periodic visits to CMOs, as required.
  • Assist with establishing and tracking of Quality metrics.
  • Effectively interact with external contract manufacturers and testing laboratories and an internal multidisciplinary team to support manufacturing, testing, and stability.
  • Manage and address associated deviations, investigations, CAPAs, change controls, OOS, Material Review Boards, product complaints etc.
  • Implement necessary Quality Agreements.
  • Assist in preparing or reviewing CMC sections of regulatory submissions.
  • Conduct audits of CMOs/ Testing Laboratories by overseeing vendor management.
  • Provide QA support for regulatory inspections.
  • Provide QA expertise in the development of Obsidian quality systems, processes, and procedures.

 

You Bring…

Core Qualifications

  • Bachelor’s degree in biology, chemistry, engineering, life sciences or a related field.
  • 10-+ years of direct Quality experience in a cGMP environment,8+ years in a Quality leadership role.
  • Experience in the Cell Therapy space.  
  • Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations.
  • A track record of good judgment in elevating issues and determining solutions and actions in high consequence situations.
  • Demonstrated ability to recognize quality issues that will result in critical delays in schedule or operations and may jeopardize overall business activities.
  • Highly collaborative working style – build trusting relationships, invite and share ideas and feedback, productively challenge own and others’ assumptions to generate new ideas and facilitate the better outcomes.
  • Self-motivation and a proven ability to work with general direction to meet objectives and timelines.
  • Flexibility, you readily adapt to changes and priorities in order to fulfill our mission.
  • Strong technical writing and scientific skills
  • Solid project management skills and experience managing complex projects.
  • Ability to travel domestically and internationally as required (estimated 20%).

Bonus Qualifications

  • Experience in analytical and process validations strongly preferred.

Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.


Apply for this Job

Back to Jobs
Obsidian Therapeutics

Privacy // Terms of Use
© 2022 Obsidian Therapeutics, Inc. All Rights Reserved.

  • About Us
  • Our Science
  • News
  • Join Our Team
  • Contact

Privacy // Terms of Use // Sitemap
© 2022 Obsidian Therapeutics, Inc. All Rights Reserved.

Our Pipeline Job Postings
We use cookies on our website to optimize your experience, analyze site usage, and to assist with our marketing activities. By continuing to navigate our website, you consent to the use of cookies, our privacy policy and terms of use.
Accept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT