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2 дня назад

Operational Excellence Lead: BioVectra (GMP Manufacturing)

146 640 - 274 950$
Формат работы
hybrid
Тип работы
fulltime
Грейд
lead
Английский
b2
Страна
US/Canada
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Operational Excellence Lead: BioVectra (GMP Manufacturing): Building and embedding a production operating system across the GMP manufacturing value stream from fermentation through release-readiness with an accent on tiered daily management, Lean deployment, and measurable performance improvement. Focus on leading kaizen and structured problem-solving, improving yield and release cycle time, and connecting shop-floor systems to sellable capacity and client commitments.

Location: US-based, with substantial on-site presence and 50–60% travel to BioVectra sites in Prince Edward Island and Nova Scotia and across the ATD footprint.

Salary: $146,640–$274,950 per year, plus eligibility for bonus, stock, and benefits.

Company

hirify.global’s Advanced Therapeutics Division includes BioVectra, a CDMO producing active pharmaceutical ingredients at clinical-to-commercial scale across microbial fermentation, small molecules, plasmid DNA, mRNA, LNP, and sterile fill.

What you will do

  • Own the production-system build across the full value stream, from incoming materials through release-readiness.
  • Deploy tiered daily management, leader standard work, visual performance management, SQDC boards, KPI ownership, and structured escalation.
  • Lead kaizen events, value-stream mapping, SMED initiatives, and improvements in yield, reproducibility, right-first-time execution, and release flow.
  • Translate business objectives into floor-level priorities, transformation roadmaps, countermeasures, and benefits tracking.
  • Use MES, electronic batch records, shop-floor data, analytics, and appropriate digital or AI tools to identify abnormalities and improve daily management.
  • Coach operators, supervisors, and emerging practitioners in A3 and PSP problem-solving, Lean fundamentals, standard work, and production-system governance.

Requirements

  • Bachelor’s or master’s degree in life science, chemical or biochemical engineering, or a related field.
  • 8+ years of experience in GMP or similarly regulated and complex production environments; 10+ years is helpful.
  • Hands-on experience deploying and sustaining a production or business operating system, including strategy deployment, tiered daily management, kaizen, standard work, visual management, and structured problem-solving.
  • Demonstrated sustained business results across safety, quality, delivery, throughput, yield, cycle time, cost, or client performance.
  • Deep expertise in root-cause analysis and structured problem-solving, with the ability to coach operators and influence senior leaders.
  • US-based availability and willingness to maintain substantial on-site presence and travel are required.

Nice to have

  • Experience in a CDMO or contract manufacturing environment.
  • Lean, Six Sigma, TPS, Danaher Business System Certified Practitioner, or Advanced Certified Practitioner certification.

Culture & Benefits

  • Full-time schedule with an option to work remotely when not deployed on site.
  • Work is based on the Gemba, with extended periods embedded at manufacturing sites during deployment.
  • Eligibility for bonus, stock, and benefits.
  • Opportunity to share operational-excellence practices across the North American ATD footprint.

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