Director/Sr Director/Executive Director Central TSMS for Oligonucleotides

BioSpace; Indianapolis (IN); On-site; USD 141,000 - 247,000; Full time

Job summary

An established industry player is seeking a dynamic Director/Sr Director/Executive Director to oversee the Central API TSMS team focused on oligonucleotide therapeutics. This pivotal role involves leading technical transfers, process validations, and optimization efforts to enhance product portfolio growth. With a commitment to excellence and innovation, the organization offers a collaborative environment where your expertise in GMP compliance and regulatory standards will be instrumental in driving success. Join a team dedicated to making a meaningful impact in healthcare while fostering a culture of respect and integrity.

Qualifications

• 5+ years in pharmaceutical manufacturing with oligonucleotide technologies.
• Proven track record in leading technical projects and compliance.

Responsibilities

• Lead the Central API TSMS team for oligonucleotide therapeutics.
• Develop control strategies for technology transfers and process validation.
• Mentor team members and drive innovation through collaboration.

Skills

Oligonucleotide API Synthesis

GMP Compliance

Regulatory Expertise

Technical Project Leadership

Process Optimization

Education

MSc/Ph.D. in Biochemistry

MSc/Ph.D. in Chemistry

MSc/Ph.D. in Chemical Engineering

Job description

Director/Sr Director/Executive Director Central TSMS for Oligonucleotides

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Job Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide work to discover and bring life-changing medicines to those in need, improve disease management, and contribute to communities through philanthropy and volunteerism. We prioritize excellence, integrity, and respect, fostering a culture that values innovation and making a difference.

Position Description

We are seeking a Director/Sr Director/Executive Director to lead the Central API TSMS team, supporting the development and manufacturing of oligonucleotide therapeutics. This role involves overseeing technical transfers, process validations, and process optimization for our expanding oligonucleotide portfolio, requiring deep industry knowledge, GMP compliance, and regulatory expertise.

Key Responsibilities

• Become a subject matter expert in oligonucleotide API synthesis to support product portfolio growth.
• Establish strong relationships with Lilly’s Development Organization for synthetic approaches and commercial transfer.
• Develop and translate control strategies into operational requirements to ensure successful technology transfers.
• Review analytical control strategies and implement process analytical technologies for monitoring and control.
• Lead resolution of technical issues related to control strategies and operational challenges.
• Manage internal and external relationships, especially with external manufacturing teams.
• Drive innovation through collaboration with technical organizations and support process characterization and documentation.
• Support technology transfers and ensure process validation and yield optimization.
• Collaborate with Regulatory teams for submissions and responses.
• Maintain processes in a validated, compliant, and controlled state.
• Lead strategic initiatives and continuous improvement efforts.
• Mentor and coach team members, fostering a collaborative environment.

Qualifications

• MSc/Ph.D. in Biochemistry, Chemistry, Chemical Engineering, or related fields with minimum 5 years of industry experience, or 10+ years overall industry experience.
• Experience with pharmaceutical manufacturing, regulatory standards, and preferably oligonucleotide technologies.
• Proven track record leading technical projects and driving manufacturing improvements.
• Legal authorization to work in the U.S. (sponsorship not provided).

Additional Information

• Occasional travel (5-10%).
• Location: Indianapolis, IN.

Lilly is committed to diversity and inclusion. We provide accommodations for applicants with disabilities. Learn more at workplace accommodation request form.

Compensation range: $141,000 - $246,400, plus benefits and bonus. Actual salary depends on experience and location.