Associate Director, Vector Ms&t

2 weeks ago

Stevenage, United Kingdom Adaptimmune Full time

**Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.**

**Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.**

The UK MS&T team are responsible for all Lentiviral Vector and plasmid DNA manufacturing process related activities at cGMP/GMP-like facilities both for internal manufacturing and through external partners. The team also plan and manage new product introductions, change controls, risk assessments, technical protocols.

MS&T team provide technical oversight for GMP Vector manufacturing operations in addition to leading regulatory document preparation (IND/IMPD/BLA), manufacturing process changes/improvements, data analytics and trending.

**Primary Responsibilities**

The purpose of the role is:

- Provide strategic leadership in the validation and BLA-readiness for lentiviral vector and plasmid DNA manufactured at external organisations.
- Provide direction and leadership to the MS&T team focussed on external supply.

**Key **Responsibilities**
- Manage/facilitate characterisation and validation studies (as appropriate) at external contract organisations, acting as technical lead and decision-making on strategy
- Lead and develop/mentor team to ensure a fit for purpose MS&T group supporting external manufacturing
- Review vector process characterisation and process performance qualification activities. Perform gap assessments as necessary.
- Lead technical writing for vector and plasmid manufacturing processes including regulatory documents
- Authoring and reviewing GMP documentation such as SOPs, deviations, change controls, CAPAs
- Coordinate process improvements and support introduction of new technologies for commercial readiness
- Extracts and summarises scientific information from development reports to support regulatory submissions
- Represents MS&T on multi-disciplinary teams for CMC-regulatory support
- Support department objectives for maintaining lifecycle projects including Continued Process Verification

**Qualifications & Experience**

**Required**
- Significant experience in cGMP aseptic manufacturing of biologics (or similar) for clinical and/or commercial use;
- Highly effective people manager with experience in managing a manufacturing team and facility in a biotech/pharma company (management of whole department(s) strongly preferred)
- Collaborative, team-based approach to working with colleagues cross functionally to drive innovation, compliance, and continuous improvement
- Ability to manage effectively in a dynamic environment while maintaining the ability to troubleshoot and ‘think outside the box”
- Excellent oral, written and influencing skills which can target audiences across all levels of seniority and all departments is essential
- Ability to be flexible with working hours e.g. able to work evenings/weekends and/or shifts if necessary for interaction with third parties
- B.S./M.S. in Chemical Engineering, Biotechnology or Life Sciences strongly recommended; (Ph.D. a plus).

**Desirable**
- Managed and/or supervised third party manufacturing or testing facilities
- Experience in technical transfer, launching new pharmaceutical/biologic products (e.g. new supply, BLA management/drafting, etc.)
- Experience with cell and gene therapy manufacturing, preferably lentiviral vector
- Experience with early stage and late stage/commercial pharmaceutical/biotech companies

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