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.
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.
Minimum Requirements:- 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
