Associate Director - Technical Services/Manufacturing Science

The Technical Services/Manufacturing Science (TS/MS) Associate Director is responsible for the staffing, training, and leadership of the TS/MS group specifically for parenteral operations (formulation, filling, visual inspection). The TS/MS group provides technical leadership for syringe filling, device assembly, and packaging operations for commercially manufactured products targeted for transfer to the RTP site.

The Associate Director will be responsible for supporting the day-to-day TS/MS activities as well as planning for the 3-6-month horizon. The TS/MS Associate Director is expected to lead by example and provide coaching to others in the areas of safety, quality, technical capability, and continuous improvement.

Key Objectives / Deliverables:

• Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Support Site Leadership to build a diverse and capable TS/MS organization, supporting the areas of device assembly, packaging, and parenteral operations.
• Deliver equipment, lines, and supporting systems through technology transfer, process validation, and control strategy development.
• Provide leadership and develop objectives to deliver business plan goals as it relates to safety, quality, and process effectiveness and efficiency.
• Determine staffing and resource needs to support site TS/MS requirements.
• Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Provide technical guidance to the TS/MS group.
• 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).
• Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
• Understand and influence the manufacturing control strategy for the various operational areas.
• Manage external contracts/resources and project management resources, as needed.
• Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
• Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.
• Drive control, capability, productivity, and continuous improvement for the process.
• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.
• Serve as technical interface external to the RTP site.
• Work within or lead cross-functional teams in positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.
• Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities.

• BS, MS, or Doctorate (Ph.D., PharmD) in Biochemistry, Chemistry, Pharmacy, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• Previous management or leadership experience, including leading or working effectively with a cross functional group

Additional Preferences:

• Strong technical aptitude and ability to train and mentor others
• Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
• Solid understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA.
• Experience supporting cGMP manufacturing (specifically within operations, technical services/MSAT, quality assurance, etc.)
• Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
• Previous facility or area start up experience
• Previous equipment qualification and process validation experience
• Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.
• Previous experience with deviation and change management systems including Trackwise

Education Requirements:

• BS, MS, or Doctorate (Ph.D., PharmD) in Biochemistry, Chemistry, Pharmacy, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline

Other Information:

• Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
• Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 - $180,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. Lilly is designed and built a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help run a state of the art manufacturing facility., Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit.