Job Description
BioVectra, now part of Agilent’s Advanced Therapeutics Division (ATD), is a CDMO producing active pharmaceutical ingredients at clinical-to-commercial scale across microbial fermentation, small molecules, plasmid DNA, mRNA, LNP, and sterile fill, operating from Charlottetown, PEI and Windsor, Nova Scotia. This posting is for the BioVectra assignment within Agilent's Operational Excellence (OEx) function.
Agilent’s Operational Excellence function builds and embeds the production system on the manufacturing floor. The function exists to convert operational performance into capacity the divisions can sell. The Operational Excellence Lead owns this build across the full value stream, from fermentation through downstream recovery and purification to release-readiness and leads through depth of expertise with no direct reports. Success depends on influence through the ATD OEX governance model: site leadership owns operating results, while this role owns method, cadence, capability build, and countermeasure discipline. This role works alongside site leadership, not above it.
What You Will Do:
- Own the production system build across the full value stream at your assigned site or campaigns, from incoming materials through to release-readiness. Begin each deployment with a structured rapid diagnostic that reads the current state of the production system, daily management, and culture through direct observation, operator interviews, and quantitative evidence, and translate the findings into a sequenced deployment roadmap agreed with site operations and quality leadership.
- Build and sustain tiered daily management from Tier 1 through Tier 4, leader standard work, visual performance management, Safety, Quality, Delivery, and Cost (SQDC) boards, and clear KPI ownership at the line, with structured escalation that surfaces and counters abnormality the shift it occurs in.
- Own and run the kaizen funnel for your value stream: prioritize, charter, and lead kaizen events and workshops that close KPI gaps in titer and yield stability, fermentation reproducibility, downstream recovery and purification yield, right-first-time execution, changeover through SMED, and the manufacturing-to-quality handoff.
- Translate site and business objectives into floor-level priorities through strategy deployment with defined ownership, milestones, countermeasures, and benefits realization.
- Connect operational performance to the outcomes the divisions care about: throughput and sellable capacity, on-time-in-full against client commitments, release cycle time, right-first-time, and the inventory, working capital, and cost that follow. Build and maintain a transformation scorecard as the single source of truth for KPI performance, value capture, and countermeasure tracking.
- Use MES, electronic batch records, shop-floor data systems, and analytics where they exist to feed the daily management system and surface process abnormality in real time. Identify where digital and AI tools earn a place in daily work, treating them as enablers of the production system rather than a parallel initiative.
- Lead and mentor structured problem-solving (A3 and PSP) at the Gemba on the real constraints across the value stream, driving teams through root-cause analysis rather than solving problems for them.
- Lead value stream mapping across the batch lifecycle, including the transactional and quality flows where sellable capacity is most often lost, batch-record review, deviation handling, and client response, then install the daily management and standard work that level the work and shorten time to release.
- Partner with Quality to support the operating-system elements of the release maturity roadmap, from conventional finished-product testing toward parametric release and real-time release testing where the process knowledge, client alignment, and regulatory pathway support it; the analytical science, filings, and release strategy belong to Quality, while the process understanding, standard work, and flow architecture belong to OEX.
- Coach and develop supervisors, operators, and emerging practitioners in standard work, daily management, structured problem-solving, and Lean fundamentals, and build the next generation of certified practitioners at all levels.
- Be the method owner for the production-system at your site. Embed standardized ways of working, governance routines, and accountability mechanisms that deliver durable results beyond individual kaizen events. Where leadership owns results and this role owns the method, cadence and countermeasure discipline that produce them.
- Anchor to the Biovectra deployment through build and stabilization, embedding deep enough that daily management and standard work hold. As that system matures, contribute to benchmarking and best practice sharing across the North American ATD footprint so hard-won lessons travel.
Qualifications
- Bachelor’s or master’s degree in a life science, chemical or biochemical engineering, or related field.
- 8+ years in a GMP or comparably regulated/complex production environment with direct, hands-on accountability for process performance across the Make value stream, 10+ years will be helpful.
- Real depth in microbial fermentation and downstream recovery and purification is the core requirement for this assignment.
- Demonstrated, hands-on experience deploying and sustaining a production or business operating system in a line role, whether the Toyota Production System, Lean, or the Danaher Business System (DBS), including strategy deployment, tiered daily management, kaizen, standard work, visual management, and structured problem-solving.
- A track record of delivering measurable, sustained business results through transformation, across safety, quality, delivery, throughput, yield, cycle time, cost, or client performance.
- Deep command of structured problem-solving and root-cause methodology applied to real process problems, with the credibility to coach operators and influence senior leaders alike.
_Location, Travel, and On-site Requirements_
- This role is US-based, with significant travel to BioVectra’s sites in Prince Edward Island and Nova Scotia, and across the broader ATD footprint as deployment phases require.
- This is a Gemba-based role. Expect substantial on-site presence, in the range of fifty to sixty percent depending on deployment phase, including extended periods embedded at a site.
_It Would Be a Plus If You Also Possess Experience In_
- A CDMO or contract manufacturing environment.
- Certification in Lean, Six Sigma, or TPS, or status as a Danaher Business System Certified Practitioner or Advanced Certified Practitioner (CP / ACP). Certification is welcome but does not substitute for a demonstrated record of building a durable system.
