Advisor/Sr Advisor Technical Services Manufacturing Science

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 90,000 - 160,000; Full time

Job summary

An established industry player in healthcare is seeking a dynamic Senior Director for its Peptide Team. This role involves providing technical and scientific expertise in the manufacturing of drug substances, ensuring compliance with regulatory standards, and leading process optimizations. The ideal candidate will have a strong background in pharmaceutical manufacturing and a proven track record of driving technical agendas. Join a passionate team committed to improving lives through innovative medicines and enjoy the opportunity to make a significant impact in the field.

Qualifications

• Ph.D. or BS/MS with extensive experience in pharmaceutical manufacturing.
• Proficiency in regulatory requirements and technical oversight.

Responsibilities

• Lead technical oversight for peptide manufacturing processes.
• Manage internal and external relationships effectively.
• Ensure compliance with US and global regulations.

Skills

Pharmaceutical Manufacturing

Technical Oversight

Process Optimization

Regulatory Compliance

Communication Skills

Education

Ph.D. in Biochemistry or related fields

BS or MS in Biochemistry or related fields

Job description

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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Job Description

Join the energetic and growing Active Pharmaceutical Ingredient -Technical Services Manufacturing Science Central Peptide Team that delivers a diverse portfolio of drug substances essential to Lilly! The Central API TS/MS Sr. Director will provide technical and scientific expertise within a dynamic Peptide team that is supporting delivery of commercialization efforts including technical transfers, process validations, and process optimization for the peptide portfolio, including Mounjaro. The Sr Director leads technical aspects of drug substance manufacturing including process optimization, technical transfers and development of the technical agenda. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions. The successful candidate should have a proven track record of driving technical agendas and influencing externally in the peptide space.

Key Objectives/Deliverables:

• Provide technical oversight and stewardship for peptides and manufacturing processes.
• Lead resolution of technical issues including those related to control strategy and manufacturing.
• Proven experience at leading post-launch technical agendas and delivering projects that have driven substantial step changes in manufacturing.
• Employ excellent communication skills to manage internal and external relationships.
• Build and maintain relationships with development and central technical organizations.
• Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Maintain peptide processes in a state of compliance with US and global regulations.
• Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Understand the chemistry and stability of peptides from a first principles perspective.
• Operate with ‘TeamLilly’ in mind – including coaching and mentoring of peers and other scientists.

Basic Requirements:

• Ph.D. in scientific disciplines of Biochemistry, Chemistry, Organic Chemistry, Chemical Engineering, or related fields with at least 3-5 years of relevant experience.

OR

• BS or MS in scientific disciplines of Biochemistry, Chemistry, Organic Chemistry, Chemical Engineering, or related fields with at least 10+ years of relevant experience.

AND

• Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Additional Preferences:

• Peptide manufacturing experience.

Additional Information:

• Occasional travel required 5 – 10%.

LOCATION:

• Indianapolis, IN
• This is an onsite position that will require onsite presence the majority of the time. This is not a remote position.