Sr./Principle Scientist - TSMS Small Molecule External Manufacturing

About the role

The API EM TS/MS Sr. Principle Scientist plays a critical role in delivering commercialization efforts including technical transfers, process validations, and process optimizations for the Small Molecule portfolio. This position requires comprehensive knowledge of the pharmaceutical industry, GMP, regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.

Responsibilities

• Provide technical oversight and stewardship for Small Molecule manufacturing processes.
• Lead resolution of technical issues including those related to control strategy and 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.
• Optimize and execute site control strategies.
• Successfully deliver on strategic initiatives.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain processes in a state of compliance with US and global regulations.
• Understand the scientific principles required for manufacturing drug substances, including the interaction of chemistry and equipment.
• Operate with 'Team Lilly' in mind - including coaching and mentoring of peers and other scientists.

Requirements

• Master’s Degree in scientific discipline of Chemistry or related fields, and 8 + years of Small Molecule API manufacturing pharma industry experience.
• Demonstrated experience with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Qualifications

• Basic qualifications include a Bachelor's degree in a scientific discipline of Chemistry or related fields, and 12+ years of Small Molecule API manufacturing pharma industry experience.

Skills

• Excellent communication skills.
• Strong problem-solving and analytical skills.
• Experience with regulatory affairs and compliance.
• Knowledge of Good Manufacturing Practices (GMP).
• Ability to work independently and as part of a team.

Benefits

• Comprehensive benefit program including 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug benefits.
• Flexible benefits such as healthcare and dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Time off and leave of absence benefits.
• Well-being benefits such as an employee assistance program, fitness benefits, and employee clubs and activities.

Pay

$66,000 - $171,600

Schedule

Full-time equivalent employees are eligible for a company bonus (depending, in part, on company and individual performance).

Location

Onsite in Indianapolis, US