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Senior Process Engineer, External Manufacturing/MSAT (Cell Therapy)

Bedford, MA

Our Opportunity…

We’re expanding our External Manufacturing/ Manufacturing Science and Technology (MSAT) team to support manufacturing with a critical CDMO partner for our clinical trials in metastatic melanoma and non-small cell lung cancer. The ideal candidate will have experience overseeing work completed at a CDMO/CMO and a strong background in cGMP requirements and their application to viral vector and mammalian cell culture manufacturing. In this role, you’ll work closely with a dedicated team to initiate and oversee technology transfer and manufacturing of our engineered autologous cell therapies. As part of our Technical Operations team, you’ll be a vital part of a highly collaborative team working to deliver OBX-115 to patients and achieve Obsidian’s vision of translating innovative science into medical breakthroughs.

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You will join a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

You Will…

• Collaborate with cross-functional teams, including the CDMO joint project team and Obsidian’s Process Development, Analytical Development, Quality Assurance, Quality Control, and Regulatory teams to assure effective tech transfers and start-up of manufacturing processes according to agreed upon timelines in support of business objectives.
• Act as a Person-in-Plant (PIP) at Obsidian’s CDMO facilities by maintaining on-site presence as needed, leading up to and during manufacturing.
• Perform detailed review, including technical oversight and ownership of batch records, validation protocols, and reports to ensure appropriate and complete content.
• Analyze the process monitoring database for the processes you are responsible for maintaining.
• Liaise with cross-functional teams (internal and external) to resolve manufacturing issues. Own process-related manufacturing investigations/deviations, change controls, complaints, and CAPAs to meet Obsidian requirements.
• Build strategic relationships within the CDMO organization and with key internal stakeholders to ensure alignment and exceptional manufacturing execution.
• Provide technical expertise and participate in FMEA and HAZOP related activities to support quality by design (QBD).
• Partner with Obsidian Process Development to support Process Characterization studies.
• Contribute to Process Validation / Process Performance Qualification (PPQ) activities in support of licensure activities.

You Bring…

Core Qualifications

• Bachelor’s degree in biological sciences, (bio)chemical engineering, or related discipline with 8+ years of experience (or MS with 6+ years) working in a Manufacturing or MSAT role in the Cell and/or Gene Therapy space. 
• Strong understanding of aseptic processing and cGMP requirements and their application to autologous cell culture manufacturing.
• Successful client-side experience overseeing work completed at a CDMO/CMO – including change, deviation, CAPA, and Tech Transfer management.
• Prior experience leading and documenting risk assessments (SIPOC, FMEA, and/or HAZOP) and root cause analysis (5-why, fishbone/Ishikawa)
• Strong competence in analyzing and interpreting manufacturing process data using statistical software such as JMP or Minitab
• Familiarity with FDA and EMA guidance documents relevant to cell and gene therapy.
• A clear sense of ownership and accountability to meet commitments and high standards, promoting the same across the CDMO manufacturing team.
• Exceptional problem diagnosis and solving skills, paired with confidence and good judgement to elevate key issues to management.
• Proven ability to manage matrixed projects and tasks to completion, anticipating risks and obstacles and adjusting to effective contingency plans.
• A highly collaborative working style – build trusting relationships, share ideas and feedback, productively challenge own and others’ assumptions to generate new ideas and facilitate 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 to fulfill our mission, including occasional after-hours or weekend oversight of ongoing manufacturing runs as needed.
• Excellent communication skills, strong technical writing and scientific skills.
• An ability to be on-site at CDMO up to 30% of the time (for day trips, the ideal location is mid-Atlantic; for other locations, travel of this amount will be required).

Bonus Qualifications

• Experience with PPQ (process validation).
• Familiarity with analytical instrumentation/methods employed for cell and gene therapy characterization (flow cytometry, ELISA, cell counting, ddPCR, etc.) is a plus.

Please no agency solicitation at this time. Thank you!

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