Our Opportunity…

We’re expanding our External Manufacturing/ Manufacturing Science and Technology (MSAT) team for a Process Engineer to support manufacturing 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 the MSAT organization, and stakeholders in the CMC (internal) and CDMO (external) teams to oversee technology transfer and manufacturing of our engineered autologous cell therapies. As part of our Technical Development and Manufacturing department you will be a vital part of a highly collaborative team working to achieve the 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 clinical company with blue chip investors, field-leading advisors, best-in-class partners, 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…

• 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.

You Bring…

Core Qualifications

• 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.

Bonus Qualifications

• 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.