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 a deep understanding of the pharmaceutical industry, GMP, regulatory requirements, and the essential role scientists play in making medicine.

Responsibilities

• Provide technical oversight and stewardship for Small Molecule manufacturing processes.
• Lead the 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 Master's degree in a scientific discipline such as Chemistry or a related field.
• Experience in the pharmaceutical industry, specifically in Small Molecule API manufacturing, is highly valued.
• Knowledge of regulatory expectations and good manufacturing practices (GMP) is essential.

Skills

• Comprehensive knowledge of the pharmaceutical industry.
• Strong understanding of GMP and regulatory requirements.
• Excellent communication and interpersonal skills.
• Ability to lead and mentor others.
• Proficiency in process optimization and validation.

Benefits

• Comprehensive benefits package including medical, dental, vision, and prescription drug coverage.
• Flexible benefits options such as healthcare and dependent care flexible spending accounts.
• Life insurance and death benefits.
• Time off and leave of absence benefits.
• Well-being benefits like an employee assistance program and fitness benefits.

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