Associate Director, GMP Technical Operations & Digitalization

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 123,000 - 180,400; Full time

Benefits offered by this job

Comprehensive benefits program

Eligibility for a company bonus

401(k) and pension plans

Job summary

Initial Therapeutics, Inc. is seeking a qualified individual to lead a team of scientists focusing on technical excellence and compliance in cGMP commercial API manufacturing. The role involves overseeing document reviews, managing staff, and implementing data analytics tools to enhance process performance.

Ideal candidates will have advanced degrees in relevant fields and extensive experience in manufacturing environments. Strong leadership and project management skills are crucial for this position, coupled with a proactive approach to influence regulatory and business objectives.

Qualifications

• 6+ years (B.S./M.S.) or 5+ years (Ph.D.) of relevant cGMP commercial API manufacturing experience.
• Hands-on experience with digitalization initiatives.
• Strategic thinking and ability to balance short‑term needs with long‑term business evolution.

Responsibilities

• Ensure technical review and approval for documents.
• Hire, manage, mentor, and develop a team of scientists.
• Champion the adoption and integration of data analytics platforms.

Skills

Team leadership

Digitalization initiatives

Project Management

Analytical skills

Education

B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences

Tools

Manufacturing execution systems (MES)

Data historian platforms (e.g., OSIsoft PI)

Job description

Initial Therapeutics, Inc. is seeking a qualified individual to lead a team of scientists focusing on technical excellence and compliance in cGMP commercial API manufacturing. The role involves overseeing document reviews, managing staff, and implementing data analytics tools to enhance process performance.

Ideal candidates will have advanced degrees in relevant fields and extensive experience in manufacturing environments. Strong leadership and project management skills are crucial for this position, coupled with a proactive approach to influence regulatory and business objectives.