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MSAT Process Scientist – Lifecycle Support

Manchester M13 9XX   •  Competitive Salary & Benefits  •  Permanent, Full time


About Instil Bio

Instil Bio is a cell therapy company developing tumor infiltrating lymphocytes (TIL) for the treatment of solid tumor cancers. TIL are a patient’s own T cells harvested from the patient’s tumor, which are then expanded and reinfused into the patient to target and kill cancer cells. Instil is advancing its proprietary TIL manufacturing expertise, technology, and data into clinical trials, including a planned registrational study with its lead candidate and a first-in-human study of its next-generation engineered TIL. The company is led by world-class cell therapy experts and backed by premier global institutional investors.

Instil Bio UK is Instil’s rapidly-growing, Manchester UK-based subsidiary. Our Manchester subsidiary has significant R&D, process development, and clinical manufacturing capabilities, with approximately 35 staff expanding to > 100 staff. Instil Bio UK has been generating cell therapy products for patient use since 2011, including TIL products and external partner genetically engineered T cell products.

MSAT Process Scientist – Lifecycle Support

Instil Bio is hiring adrivenMSATProcess Scientist – Lifecycle Support, to the join the MSAT Team in Manchester, UK, reporting to the MSAT Lead. Your work will directly support and advance the Instil Bio pipeline of life-saving cell therapy product during clinical trials (first-in-human and pivotal).

The MSAT team will support ongoing manufacturing processes, review sampling plans, design and execute technology transfers, and participate in validation and comparability exercises for Instil Bio products. Occasional travel to the US is expected in this role (< 10%).

You will leverage scientific and engineering acumen, and positively influence the manufacturing and quality teams to implement the best scientific decision making in manufacturing and quality operations to support successful clinical manufacturing and product release to patient. As we build the team, you will enhance your experiences by supporting many roles to advance the Instil Bio product portfolio. As the team expands, your role will focus on the process and method lifecycle. Overall, the MSAT organization supports:

  • Manufacturing process execution
  • Trending in process and lot release performance
  • Risk management, investigations, and change management
  • Transfers, comparability and validation

Responsibilities (include but not limited to):

You will be the scientific expert for the product lifecycle and you will actively engage with the manufacturing and quality teams to ensure process transfer, comparability and validation are on-time and successful.

All MSAT staff will be expected to:

  • Train manufacturing staff
  • Provide Person-in-Plant support on occasion
  • Recommend manufacturing operation improvements and best practices

You will work with the MSAT lead to:

  • Lead process lifecycle exercises include transfer, validation and comparability. You will:
    • Develop, justify and document acceptance criteria for the product, process and method transfers
    • Author Master plans, protocols, reports and lifecycle planning improvements
    • Provide Person-in-Plant support for transfer, validation and comparability manufacturing and method transfers

You will work closely with the MSAT team and cross-functional organizations to:

  • Recommend manufacturing operation improvements and best practices
  • Perform process risk assessments implementing quality by design principles
  • Support non-conformances, corrective actions, and preventative actions
  • Trend the process and method performance

You will author and review technical assessments and technical reports and contribute to regulatory filings to advance the Instil Bio product portfolio. You will participate in cross-functional meetings and report findings to management, so clear communication in verbal and written forms is essential. As a growing company, other duties may also be assigned.

Requirements and Recommendations:

  • Degree in Biochemical Engineering, Biotechnology, Immunology, Chemical Engineering, or related discipline. Recommended degree and biopharmaceutical manufacturing experience:
    • Masters degree with at least 2 years experience or
    • Bachelors degree with at least 5 years experience
  • It is critical that you have:
    • Experience with biopharmaceutical product transfer, comparability and validation
    • Experience with statistical analysis of biopharmaceutical products
  • It is strongly encouraged that this role have:
    • Experience in aseptic cell culture techniques
    • Experience with risk management, regulatory filings or audits
    • Experience with troubleshooting, remediation and investigation tools
  • Personal Skills:
    • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
    • Excellent interpersonal, verbal and written communication skills
    • Ability to function efficiently and independently in a changing environment
    • Self-motivated and willing to accept temporary responsibilities outside of initial job description
    • Well-developed computer skills

Remuneration & Benefits

The salary for the MSAT Process Scientist – Lifecycle Support will be competitive within the Biotechnology and wider Scientific sector with actual salary offered reflecting relevant qualifications and experience as well as performance at interview.

Application Process

If you would like to join us as MSAT Process Scientist – Lifecycle Support at this critical time in our development and you think your skills and experience are a good fit for this role apply with a current CV and we’ll get back to you within a day or two.

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Related skills: Biology, Cell & Molecular Biology, Chemical Engineering, Chemistry, Life Science, Process Chemistry

  • Employer: Instil Bio (UK)
  • Updated: 17th September 2020
  • Expires: 30th September 2020

Instil Bio (UK)

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