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Senior Specialist, External Manufacturing

Employer
Obsidian Therapeutics
Location
Bedford, MA
Start date
May 10, 2022

View more

Discipline
Clinical, Clinical Medicine, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown

Job Details

Senior Specialist, External Manufacturing

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 preclinical development for the treatment of patients with metastatic melanoma and other solid tumors.

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 to join us as a Senior Specialist, External Manufacturing with a strong background in GMP manufacturing to contribute to building Obsidian’s CMC team.  In this role, you’ll work collaboratively with the Associate Director of External Manufacturing, internal and external stakeholders on CMC (internal) and CDMO (external) teams to oversee technology transfer and manufacturing of our engineered cell therapies. 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.

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.

This opportunity is available at our Bedford, MA location, but we will also consider candidates located in the Philadelphia metro region to work remotely with travel to the Boston area as necessary.

You Will… 

  • Assist the External Manufacturing leader with manufacturing oversight of CDMOs for tech transfer and manufacturing activities 
  • Collaborate with cross-functional teams, including the CDMO joint process team, Obsidian Process and Analytical Development, Quality Assurance, Quality Control and External Manufacturing.
  • Perform detailed review of draft and completed batch records
  • Align with CDMO on the appropriate formats and frequency of process and analytical data packages (raw data, graphed data, and other data summaries and presentations) and ensure delivery of such packages to enable Obsidian monitoring and analysis of data.
  • Liaise with cross-functional team to resolve manufacturing issues along with daily review of manufacturing investigations, change controls, complaints, and CAPAs.
  • Act as a Person-in-Plant (PIP) at Obsidian’s CDMO facilities by maintaining on-site presence as needed for extended periods (including some off-hours days to resolve urgent issues) as required, leading up to and during batch manufacturing.
  • Ensure that manufacturing and tech transfer activities are performed according to agreed upon timelines in support of business objectives.
  • Work closely with CDMO and internal Quality, Supply Planning and Technical teams to prioritize and track documentation (including but not limited to change controls, investigations, and deviations) to meet Obsidian requirements.
  • Manage shipments of critical materials to and from external partners as required.
  • Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
  • Partner with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation process including but not limited to change controls and impact assessments.

You Bring… 

Core Qualifications 

  • Bachelor’s degree (Master’s degree preferred) in Life Sciences or related discipline
  •  5+ years of experience working in a bio-pharmaceutical manufacturing or MSAT role in the Cell Therapy space. 
  • Experience with cell culture techniques including but not limited to activation, transduction, and expansion of T cells.
  • Prior experience with Tech Transfer of a process to GMP manufacturing.
  • Quality and compliance background in a clinical GMP operational environment.
  • A focus on results while maintaining adherence to GMP compliance.
  • A 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, ability to adapt to changes and priorities in order to fulfill our mission.
  • Confidence and good judgement to elevate relevant issues to project lead and line management.
  • Strong technical writing and scientific skills.
  • Solid project management skills and experience managing complex projects.

Bonus Qualifications 

  • Prior experience working at or overseeing work completed at a CDMO/CMO.
  • Experience with PPQ (process validation).
  • Experience with T cells including TILs.
  • Experience with gene therapy, including retroviral or lentiviral vectors
  • Familiarity with FDA and EMA guidance documents relevant to cell and gene therapy

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.

Company

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients for the treatment of cancer and other diseases. Obsidian’s programs apply our CytoDRiVETM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidians’ lead program is currently in clinical development for the treatment of patients with metastatic melanoma and other solid tumors.


Our aspirations are high, and we’re built to deliver – well-funded with blue chip investors, engaged field-leading advisors, strong partnerships with industry leaders, and a highly experienced, dynamic, innovative and collaborative team, collectively focused on delivering transformative therapies in areas of greatest clinical need.


We’re proud of our diverse talented team and committed to cultivating an environment 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 new facility in Bedford, MA. We offer competitive salary and benefits, and potential for employee ownership through stock options.
 

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Company info
Website
Phone
(781) 806-6245
Location
1030 Massachusetts Avenue
Cambridge
Massachusetts
02138
United States

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