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

Gilead Sciences Europe Ltd.; Uxbridge; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company is seeking an Associate Director in Uxbridge for their External Manufacturing Science & Technology team. This role entails providing technical oversight for external manufacturers producing viral vectors, ensuring compliance, and collaborating with internal teams to solve technical challenges. Candidates should have over 10 years of experience and a relevant degree, with expertise in GMP compliance and manufacturing operations. Strong communication and project management skills are essential for success.

Qualifications

• 10+ years of relevant experience with Bachelor's, 8+ years with Master's, or 5+ years with PhD.
• Strong GMP compliance and manufacturing operations knowledge.
• Experience with viral vector process development and GMP manufacturing support.

Responsibilities

• Provide technical oversight for external manufacturing partners.
• Lead manufacturing activities and ensure compliance.
• Interface with internal teams to resolve technical challenges.

Skills

Technical oversight

Strategic thinking

Excellent communication

Project management

Team collaboration

Education

Bachelor's, Master's Degree, or PhD in relevant fields

Tools

JMP for data analysis

Job description

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 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 Kite’s primary technical point of contract for UK-based CMOs producing viral vector
• Lead Kite’s hypercare of manufacturing activities at the CMO
• Provide technical expertise for manufacturing operations, including deviation resolutions, representing Kite in the CMO’s root cause investigations, authoring impact assessments, and overseeing CAPA implementation
• Review and assess 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 Kite’s 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: Bachelor's, Master's 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

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 individual’s 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.

For Current Gilead Employees and Contractors

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