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Lab Operations Director

Job in Louisville, Jefferson County, Kentucky, 40201, USA
Listing for: X4 Life Sciences
Full Time position
Listed on 2026-10-11
Job specializations:
  • Manufacturing / Production
    Pharmaceutical Manufacturing, Operations Management, Chemical Manufacturing
Salary/Wage Range or Industry Benchmark: 140000 - 230000 USD Yearly USD 140000.00 230000.00 YEAR
Job Description & How to Apply Below

We are seeking an experienced Business Unit Manager to lead a growing oligonucleotide synthesis and manufacturing operation within a global life sciences organization.

This is a highly technical leadership position with responsibility for the performance, development and growth of an established oligonucleotide business. The ideal candidate will combine deep hands-on expertise in oligonucleotide synthesis with experience leading manufacturing, process development or technical operations teams.

This is not a general laboratory management role.
Direct experience with oligonucleotide synthesis and the underlying chemistry/processes is a key requirement.

The successful candidate will have the opportunity to take ownership of a technically sophisticated operation, develop a high-performing team, improve manufacturing processes and capacity, support customer programs, and progressively take on broader business and financial responsibility.

Key Responsibilities
  • Oligonucleotide Synthesis & Technical Leadership
  • Provide technical leadership across oligonucleotide synthesis and manufacturing activities.
  • Apply deep knowledge of solid-phase oligonucleotide synthesis and phosphoramidite chemistry to manufacturing and process challenges.
  • Oversee and optimize synthesis, purification and downstream processing activities.
  • Support scale-up, process development, technology transfer and manufacturing implementation.
  • Identify opportunities to improve yield, quality, throughput, cycle time and cost.
  • Provide technical direction on equipment, automation and manufacturing technologies.
Manufacturing & Operations
  • Lead day-to-day operations across the oligonucleotide manufacturing environment.
  • Establish and monitor operational KPIs covering safety, quality, delivery, productivity, capacity and cost.
  • Drive Lean, continuous improvement and process optimization initiatives.
  • Ensure manufacturing activities operate in accordance with GMP/cGMP, FDA and applicable regulatory requirements
    .
  • Support PPQ, validation, process characterization and change-control activities.
  • Work closely with Quality, Engineering, Supply Chain, Commercial and R&D teams.
  • Lead, develop and retain a multidisciplinary technical and manufacturing organization.
  • Develop scientists, engineers, chemists and manufacturing leaders.
  • Build organizational capability as the business scales.
  • Establish clear performance expectations and create a culture of accountability and continuous improvement.
Business & Commercial Leadership
  • Take increasing ownership of the Business Unit's financial and operational performance.
  • Partner with commercial teams to support existing customers and develop new business opportunities.
  • Understand customer requirements and translate them into manufacturing and technical solutions.
  • Contribute to pricing, capacity planning, capital investment and business-growth decisions.
  • Identify opportunities for new products, services and manufacturing capabilities.
Strategic Development
  • Develop and execute plans to increase manufacturing capacity and operational efficiency.
  • Evaluate new technologies, equipment and processes.
  • Support capital expenditure and facility-development initiatives.
  • Help define the long-term technical and commercial strategy of the business unit.
Required Experience
  • Significant professional experience in oligonucleotide synthesis
    .
  • Strong understanding of phosphoramidite-based solid-phase oligonucleotide synthesis
    .
  • Experience with oligonucleotide purification and downstream processing.
  • Experience progressing oligonucleotide processes from development into manufacturing/scale-up.
  • Experience working within GMP/cGMP-regulated pharmaceutical or life sciences environments
    .
  • Demonstrable experience leading technical, scientific or manufacturing teams.
  • Strong understanding of manufacturing process optimization and continuous improvement.
  • Bachelor's degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences or a related discipline.
Highly Preferred
  • Experience with DNA/RNA, ASO, siRNA or other therapeutic oligonucleotide products.
  • Experience with automated oligonucleotide synthesizers.
  • Experience with HPLC-based purification and analytical characterization.
  • Experience with process validation, PPQ, technology transfer or process characterization.
  • Experience managing manufacturing operations at increasing scale.
  • Experience with FDA-regulated API or pharmaceutical manufacturing.
  • Experience with Lean/Six Sigma or similar continuous improvement methodologies.
  • Previous budget, P&L,…
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