Eli Lilly and Company · 19 hours ago
Sr. Director - Process Operations Drug Product MSAT
Durham, NC
Full-time
Onsite
Director/Executive
$164K/yr - $240K/yr
10+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. The Sr. Director - Process Operations Drug Product MSAT will provide leadership to the Technical Services / Manufacturing Science function at the Lilly RTP site, overseeing control strategy aspects of parenteral, device assembly, and packaging operations while ensuring compliance with safety and quality standards.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Active member of the RTP Site Lead Team ensuring safety, quality, and operational excellence
Provide Health, Safety and Environmental (HSE) and Quality leadership for areas of responsibility. Ensure function meets cGMP requirements. This role has direct interaction with Regulatory Agencies during site inspections
Support Site Leadership to build a diverse and capable site organization. Talent management, development, and retention within the RTP organization (and beyond)
Provide site functional leadership and develop objectives to deliver Business and Strategic Plan Goals as it relates to safety, quality, and technical effectiveness and efficiency
Oversee the manufacturing of RTP products process control and validation strategy. The scope of the role includes those commercially manufactured and targeted for RTP in the device assembly, packaging, and syringe filling operations
Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Lead risk management activities as it pertains to products
Support the delivery of equipment and supporting systems through user requirements, design, build, commissioning, qualification, validation, and subsequent operation
Support and/or lead TSMS technical projects to improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the tech agenda
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
Develop local processes and procedures for the TS/MS function
Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps
Ownership of the Site Validation Plan and lead site validation efforts
Ownership of the Site Sterility Assurance Plan
Drive stability strategy for RTP products
Ensure the function is aligned and driven to meet production throughput goals including daily operation, deviation and change management, variability reduction, and equipment/system reliability
Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance
Active leadership in the implementation of Lean principles and the site Value Stream Map
Partner with Engineering, Quality and Operations leadership meet deliver operational results
Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA)
Represent RTP capabilities to an increasing global customer base, other Lilly sites and corporate groups
Continuous improvement champion
Qualification
Required
At least 10 years cGMP parenteral manufacturing experience
At least 5 years technical management or leadership experience including leading or working effectively with a cross functional group
Excellent interpersonal, written and oral communication skills
Strong technical aptitude and ability to train and mentor others
Ability to handle multiple competing priorities
Bachelors Degree in chemistry, engineering, or biology
Preferred
Demonstrated regulatory inspection experience
Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
Previous equipment qualification and process validation experience
Previous experience with deviation and change management systems
Benefits
Company bonus
Company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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2026-01-25
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