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X4 Life Sciences · Louisville
The Opportunity
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
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.
People Leadership
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.
Essential
Strong understanding of
phosphoramidite-based solid-phase oligonucleotide synthesis .
Experience progressing oligonucleotide processes from development into manufacturing/scale-up.
Experience working within
GMP/cGMP-regulated pharmaceutical or life sciences environments .
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.
Experience with DNA/RNA, ASO, siRNA or other therapeutic oligonucleotide products.
Experience with process validation, PPQ, technology transfer or process characterization.
Previous budget, P&L, commercial or customer-facing responsibility.
Technical Background
Phosphoramidite chemistry
Solid-phase oligonucleotide synthesis
DNA/RNA synthesis
Coupling, capping, oxidation/sulfurization and detritylation
Cleavage and deprotection
Oligonucleotide purification
RP-HPLC / IEX-HPLC
Desalting and concentration
Lyophilization
Process development and scale-up
Automated synthesis platforms
GMP manufacturing
Process characterization
PPQ / validation
Technology transfer
Manufacturing science and technology
What Success Looks Like
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
Oligonucleotide Scientist → Senior/Principal Scientist → Process Development/Manufacturing Leader → Associate Director/Director → Business Unit Leadership
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.
Details
| Company | X4 Life Sciences |
| Location | Louisville |
| Type | FULL TIME |
| Niche | Full-time |