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Associate Director, Manufacturing

astrazeneca · Singapore

New
Senior 🇬🇧 English
cGMP CAPA Change control Lean MES Process validation Technical transfer

Job description

About the role

AstraZeneca is building its first biologics manufacturing campus in Singapore, a USD 1.5 billion investment delivering end-to-end Antibody-Drug Conjugate (ADC) capabilities, small-molecule chemical API production, large-molecule monoclonal antibody manufacturing, conjugation, sterile filling and lyophilization, and final secondary packaging. The Associate Director of Manufacturing leads day-to-day GMP manufacturing execution across the Singapore ADC buildings, keeping complex operations flowing, ensuring right-first-time outcomes and building team capability to meet a fast-evolving production schedule.

Key responsibilities

  • Lead daily and weekly execution of the approved production plan across shifts, prioritizing work and protecting safe batch progression and schedule adherence.
  • Maintain visible shopfloor leadership, coach first-line leaders, reinforce standard work and close performance gaps.
  • Uphold cGMP, process safety, containment controls and local requirements, and ensure hazards and risks are controlled.
  • Ensure timely initiation of deviations, lead or sponsor root cause analysis and deliver effective CAPAs.
  • Drive operational readiness for systems, areas and campaigns, including procedures, batch records, training, staffing, line readiness, materials, cleaning, digital workflows and acceptance of qualified equipment.
  • Coordinate with QA, QC, Engineering, Validation, Safety, Supply Chain, MSAT and project teams, resolving issues within delegated authority.
  • Represent Manufacturing in technical transfer, process validation and change implementation.
  • Deploy approved Lean, digital and AI-enabled solutions to improve flow, reliability, changeover, cycle time and productivity without compromising GMP or safety.
  • Establish tier performance management tracking safety, quality, delivery, cost and people metrics.
  • Lead and develop shift and team leaders, support succession plans and foster an inclusive, accountable culture.
  • Maintain inspection-ready operations and documentation, and support inspection responses.

Required profile

  • Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Engineering, Biotechnology or a related scientific or engineering subject.
  • Minimum 10 years of relevant pharmaceutical or biopharmaceutical experience, including substantial leadership in cGMP manufacturing, technical operations or operational readiness.
  • Experience leading manufacturing operations and teams in a regulated environment; shift-based or 24/7 exposure strongly preferred.
  • Experience supporting facility start-up, major equipment introduction, technical transfer, process validation, new product introduction or capacity expansion.
  • Proven people leadership, coaching, communication, judgement and decision-making skills.

Required skills

  • Strong working knowledge of highly controlled manufacturing in drug substance, drug product or drug linker.
  • Production planning, shopfloor management, deviation and CAPA delivery, change control, inspection readiness and cross-functional issue resolution.
  • GMP documentation and operational risk management; experience fronting GMP, safety and corporate audits or inspections.
  • Lean or structured problem-solving methods.
  • Desirable: advanced degree, Lean Six Sigma, experience with MES, automation or AI-enabled solutions in GMP, greenfield/brownfield start-ups, and familiarity with Singapore regulatory expectations.

The role works on average at least three days per week from the office, with flexibility.

Questions fréquentes

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Source : ats:workday

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Published 5 hours ago

Expires 1 month from now

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astrazeneca

Singapore