Associate Director, Process Engineering, External Manufacturing Science & Technology (MSAT)

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Job Description

Kite is seeking a highly motivated technical expert to join our External Manufacturing Science & Technology (MSAT) team within the network MSAT unit as Associate Director Process Engineering.

The role will provide technical oversight and leadership for external manufacturing partners producing of our viral vector(s) and will serve as a key liaison between Kite and our UK-based partners.

The position combines strategic and technical manufacturing oversight for routine operations and onsite technical support to ensure robust compliant and efficient production of vector for clinical and commercial manufacturing.

The role requires strong influencing skills to drive alignment and technical excellence across internal and external project teams.

Key responsibilities

External Manufacturing Oversight

• Serve as Kites primary technical point of contract for UK-based CMOs producing viral vector

• Lead Kites hypercare of manufacturing activities at the CMO

• Provide technical expertise for manufacturing operations including deviation resolutions representing Kite in the CMOs root cause investigations authoring impact assessments and overseeing CAPA implementation

• Review and assessing trend data shared by CMOs and proactively identify and develop plan to remediate trend

• Coordinate with the CMO to oversee routine continuous process verification (CPV) and process improvement initiatives

• Act as single point of contact to relay Kites perspectives for key manufacturing activities scenario planning and qualification work for key raw materials to ensure business continuity

• Other external manufacturing support activities as assigned by leadership

Onsite Technical Support

• Act as Expert-in-Plant during critical operations (e.g. PPQ runs process changes investigations) and collaborate effectively with Kite and CMO staff in project teams

• Participate in daily huddles with CMO teams (triaging with existing Kite staff in the UK) and facilitate communications to Kite project teams in the US

• Observe high-risk operations and provide real-time technical guidance

• Lead or support resolution of technical investigations leveraging common root cause investigation tools such as DMAIC Ishikawa diagram 5 whys and/or pareto chart

Cross-Functional Collaboration

• Interface with internal project teams (MSAT PD AD Quality Regulatory Supply Chain Alliance Management) to escalate issues and ensure timely resolution of technical challenges

Your profile

• Education: Bachelors Masters Degree or PhD in Biochemical Engineering Chemical Engineering Biomedical Engineering Biotechnology Biology Biochemistry or Chemistry

• Experience: 10 years (Bachelors) 8 years (Masters) 5 years (PhD) of relevant experience.

Your experience

• Proven track record of MSAT and Tech Transfer experience supporting contract and strategic alliance Manufacturing

• Experience with viral vector process development and GMP manufacturing support is a strong plus

• Strong knowledge of GMP compliance regulations and Manufacturing Operations

• Expertise in Process Validation lifecycle and especially PPQ Comparability and CPV

• Cell culture and aseptic processing experience

• Experience with Risk Management tools (eg. FMEA)

• Experience in Project Management and Project Management Methodology

• Experience in use of JMP for data analysis and DOE

• Excellent presentation and communication skills

• Must be able to function and contribute as part of a team have excellent communication skills and contribute to team-based decisions

• Self-motivated and willing to accept temporary responsibilities outside of initial job description

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

• Must be eligible to work in the UK

The position will be based in the UK but as part of external MSAT domestic and/or international travel may be required up to 50% of the time.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

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