Senior Director, Biologics Purification & CMC Strategy

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 156,000 - 229,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision coverage

Well-being programs

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Senior Director to lead the purification CMC function for biologics. You will drive downstream process development, scale-up, viral clearance strategy, technology transfer, and regulatory submissions across monoclonal antibodies and related products.

The role focuses on strategic direction, adoption of emerging technologies, and collaboration with Discovery, Manufacturing, and Regulatory to advance programs from preclinical to registration.

Qualifications

• Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or related fields with 10+ years pharma industry experience, or M.S. with 18+ years of applicable experience.
• Deep knowledge of bioproduct development from candidate selection through regulatory submission.
• Strong track record of technology innovation in downstream bioprocessing or other biologics CMC areas.
• Excellent communication, interpersonal, and leadership skills.
• Experience leading high-performance scientific teams of 10+ employees.

Responsibilities

• Leads purification development including viral safety to enable development, scale-up, and tech transfer.
• Sets strategic direction of the department to support portfolio growth and objectives.
• Ensures adoption of emerging technologies and regulatory initiatives.
• Defines and drives innovation roadmap aligned with Discovery and manufacturing needs.
• Allocates resources to meet changing portfolio demands and accelerate programs.
• Leads adoption and integration of AI/ML tools, process modeling, and high-throughput screening.
• Develops talent and coaches staff; manages performance.
• Oversees development lab operations and scale-up facilities with safety focus.
• Collaborates with leaders across departments to improve overall business effectiveness.

Skills

Leadership

Communication

Interpersonal skills

Strategic planning

Education

Ph.D. in Chemistry/Biochemistry/Chemical Engineering or related fields

M.S. with 18+ years of applicable experience

Tools

AI/ML tools

Process modeling

High-throughput screening

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks a Senior Director to lead the purification CMC function for biologics. You will drive downstream process development, scale-up, viral clearance strategy, technology transfer, and regulatory submissions across monoclonal antibodies and related products.

The role focuses on strategic direction, adoption of emerging technologies, and collaboration with Discovery, Manufacturing, and Regulatory to advance programs from preclinical to registration.