Senior Process Engineer, MSAT (Cell Therapy/Viral Vectors)

Obsidian Therapeutics - Bedford, MA

Full-time - Mid Level

Bedford, MA

Administrative and Support Services

About the position

Obsidian Therapeutics is expanding the reach of TIL therapy, pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. The company is currently investigating its lead program OBX-115 and enrolling patients in an ongoing clinical trial in advanced or metastatic melanoma. The Technical Development, Manufacturing & Quality team is based in Bedford, MA, where the Senior Process Engineer will play a crucial role in supporting manufacturing for clinical trials in metastatic melanoma and non-small cell lung cancer. This position requires a strong background in cGMP requirements and their application to viral vector and mammalian cell culture manufacturing, as well as experience overseeing work completed at a CDMO/CMO. In this role, the Senior Process Engineer will collaborate with cross-functional teams, including the CDMO joint project team, Obsidian Process and Analytical Development, Quality Assurance, Quality Control, and Regulatory to ensure effective tech transfers and the start-up of new manufacturing processes. The engineer will act as a Person-in-Plant (PIP) at Obsidian's CDMO facilities, maintaining an on-site presence as needed, leading up to and during manufacturing. Responsibilities include performing detailed reviews of batch records, validation protocols, and reports, analyzing process monitoring databases, and resolving manufacturing issues in collaboration with internal and external teams. The ideal candidate will contribute to Process Validation/Process Performance Qualification (PPQ) activities and support Process Characterization studies, ensuring that the manufacturing processes align with Obsidian's vision of translating innovative science into medical breakthroughs for patients. This position offers a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors and a highly collaborative culture, focused on delivering transformative therapies in areas of greatest clinical need.

Responsibilities

• Collaborate with cross-functional teams, including the CDMO joint project team, Obsidian Process and Analytical Development, Quality Assurance, Quality Control, and Regulatory to assure effective tech transfers and start-up of new 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 along with ownership of process-related manufacturing investigations/deviations, change controls, complaints, and CAPAs to meet Obsidian requirements.
• Build and maintain strategic relationships within the CDMO organization and with key internal stakeholders.
• 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.

Requirements

• Bachelor's degree in biological sciences, (bio)chemical engineering, or related discipline with 5+ years of experience (or MS with 3+ years) working in a Manufacturing or MSAT role in the Cell Therapy and/or Viral Vector space.
• Strong understanding of aseptic processing and cGMP requirements and their application to viral vector and mammalian cell culture manufacturing.
• Successful experience working at or 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.
• Confidence and good judgement to elevate relevant issues to management.
• Proven initiative, problem-solving, and ability to manage matrixed projects and tasks to completion.
• A highly collaborative working style - build trusting relationships, and 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.
• Ability to travel up to 30% of the time.

Nice-to-haves

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

Benefits

• Competitive salary and benefits
• Potential for employee ownership through stock options