Lab Operations Director

X4 Life Sciences; Louisville (KY); On-site; USD 140,000 - 230,000; Full time

Job summary

X4 Life Sciences in Kentucky is seeking an experienced Business Unit Manager to lead a growing oligonucleotide synthesis and manufacturing operation within a global life sciences organization. The role combines deep hands-on expertise in oligonucleotide chemistry with leadership of manufacturing, process development or technical operations teams.

This is not a general lab management role. Direct experience with oligonucleotide synthesis and phosphoramidite chemistry is a key requirement.

Qualifications

• Significant experience in oligonucleotide synthesis and manufacturing.
• Experience leading technical/manufacturing teams in GMP environments.
• Strong understanding of phosphoramidite-based solid-phase oligonucleotide synthesis.

Responsibilities

• Provide technical leadership across oligonucleotide synthesis and manufacturing activities.
• Oversee synthesis, purification and downstream processing.
• Drive scale-up, process development and technology transfer.
• Improve yield, quality, throughput, cycle time and cost.
• Lead cross-functional collaboration with Quality, Engineering, Supply Chain and R&D.

Skills

Oligonucleotide synthesis

Manufacturing leadership

GMP knowledge

Process development

Technical operations

Education

Bachelor's degree in Chemistry

Tools

Automated synthesizers

HPLC purification

Job description

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, commercial or customer-facing responsibility.

Technical Background

Strong candidates may have experience with areas including:

• Solid-phase oligonucleotide synthesis
• DNA/RNA synthesis
• Coupling, capping, oxidation/sulfurization and detritylation
• Cleavage and deprotection
• RP-HPLC / IEX-HPLC
• Desalting and concentration
• Process development and scale-up
• Automated synthesis platforms
• GMP manufacturing
• Process characterization
• PPQ / validation
• Technology transfer
• Manufacturing science and technology

What Success Looks Like

Within the first 12–18 months, the successful candidate will:

• Establish strong technical and operational leadership across the business unit.
• Improve manufacturing productivity, quality and capacity.
• Develop and strengthen the scientific and manufacturing organization.
• Identify and implement meaningful process improvements.
• Build strong relationships with internal stakeholders and customers.
• Contribute to the growth and commercial development of the business.
• Take increasing ownership of the Business Unit's financial and strategic performance.

The Ideal Profile

The strongest candidate is likely to be someone who has followed a progression such as:

They should be technically credible enough to challenge and guide experienced oligonucleotide scientists and manufacturing teams, while also having the leadership potential to take broader operational and commercial ownership.

This role could suit an experienced oligonucleotide synthesis scientist/process development leader who is ready to make the transition into broader business-unit leadership, as well as an established oligonucleotide manufacturing leader with existing operational management experience.