Site General Manager - Oligonucleotide Manufacturing

X4 Engineering; Louisville (KY); On-site; USD 180,000 - 240,000; Full time

Job summary

X4 Engineering is seeking a seasoned General Manager to lead a growing oligonucleotide manufacturing business within a global life sciences organization. You will own operational performance, drive manufacturing excellence and lead a multidisciplinary team to deliver profitable growth.

The role demands deep experience in oligonucleotide production, GMP/cGMP environments and proven ability to scale processes from development to commercial manufacturing while managing budgets and strategic

Qualifications

• Experience in oligonucleotide, nucleic-acid or related synthetic chemistry manufacturing.
• Experience in GMP/cGMP environments.
• Proven leadership of manufacturing, technical operations or a business unit with people and financial responsibility.
• Experience scaling processes from development into commercial manufacturing.
• A degree in chemistry, biochemistry, chemical engineering, pharmaceutical sciences or a related discipline.

Responsibilities

• Own the overall operational and financial performance of the business unit, including revenue, profitability, costs and resource planning.
• Lead day-to-day oligonucleotide manufacturing operations, ensuring production targets and quality standards.
• Lead and develop a multidisciplinary team across manufacturing, technical operations, quality and support functions.
• Drive continuous improvement, productivity and cost-reduction initiatives across the operation.
• Oversee manufacturing capacity, production planning, equipment utilization and capital requirements.
• Partner with technical and scientific teams on process development, scale-up and manufacturing readiness.
• Ensure GMP/cGMP, quality and regulatory compliance across the operation.
• Develop budgets, forecasts, headcount plans and capital expenditure requirements.

Skills

Leadership

Operational management

Financial ownership

People leadership

GMP/cGMP experience

Process development

Scale-up

Commercial operations

P&L management

Budgeting

Education

Chemistry/Biochemistry/Chemical Engineering/Pharmaceutical Sciences

Job description

We are seeking an experienced General Manager to lead a growing oligonucleotide manufacturing business within a global life sciences organization.

This is a broad leadership position combining operational management, manufacturing, commercial performance, financial ownership and people leadership. The successful candidate will have responsibility for the overall performance of the business unit, ensuring high-quality, reliable production while driving efficiency, customer satisfaction and profitable growth.

The role would suit a leader with a strong background in oligonucleotide or nucleic-acid manufacturing, ideally combined with experience in GMP/cGMP environments, process development, scale-up and commercial operations.

Key Responsibilities

• Own the overall operational and financial performance of the business unit, including revenue, profitability, costs and resource planning.
• Lead day-to-day oligonucleotide manufacturing operations, ensuring production targets, quality standards and customer requirements are consistently achieved.
• Lead and develop a multidisciplinary team across manufacturing, technical operations, quality and support functions.
• Drive continuous improvement, productivity and cost-reduction initiatives across the operation.
• Oversee manufacturing capacity, production planning, equipment utilization, capital requirements and facility development.
• Partner closely with technical and scientific teams on process development, scale-up, technology transfer and manufacturing readiness.
• Ensure appropriate compliance with GMP/cGMP, quality and regulatory requirements.
• Work closely with Quality to maintain robust systems for deviations, CAPA, change control, investigations and audit readiness.
• Build strong relationships with customers and internal stakeholders, ensuring the business consistently delivers against commercial and technical expectations.
• Identify opportunities for business growth, new products, additional capabilities and improved customer service.
• Develop and manage budgets, forecasts, headcount plans and capital expenditure requirements.
• Establish and monitor KPIs covering safety, quality, delivery, productivity, customer satisfaction and financial performance.
• Work with senior leadership to develop and execute the strategic direction of the business unit.

Ideal Background

The successful candidate will ideally bring:

• Significant experience within oligonucleotide, nucleic-acid or related synthetic chemistry manufacturing.
• Experience with oligonucleotide synthesis, purification and/or downstream processing, with a strong understanding of the manufacturing process.
• Experience working within a GMP/cGMP-regulated manufacturing environment.
• Proven experience leading manufacturing, technical operations or a business unit with meaningful people and financial responsibility.
• Experience scaling processes from development into commercial manufacturing.
• Strong understanding of process improvement, capacity optimization and operational excellence.
• Experience managing cross-functional teams across manufacturing, quality, R&D and commercial functions.
• Strong commercial and financial acumen, with the ability to understand and manage P&L, budgets, costs and investment decisions.
• Excellent communication and stakeholder-management skills.
• A degree in chemistry, biochemistry, chemical engineering, pharmaceutical sciences or a related discipline is preferred.

What Will Make Someone Successful

This is not a purely scientific or laboratory leadership position. The successful candidate will be someone who can combine technical credibility with the ability to run and grow a business.

The strongest candidates will be able to demonstrate a progression from technical/manufacturing expertise into broader people, operational, commercial and financial leadership.

Experience with oligonucleotides is highly desirable, particularly where the candidate has been involved directly in manufacturing, process development, scale-up or technology transfer.

The Opportunity

This is an opportunity to take ownership of a specialist genomics business within a large, international life sciences organization, with significant scope to influence operations, growth strategy, manufacturing capability and organizational development.

The role offers the opportunity to operate with considerable autonomy while benefiting from the resources, infrastructure and global reach of a larger organization.