Associate VP Technical Services/Manufacturing Science (Indianapolis Parenteral Mfg)

Lilly • Indianapolis, IN

28d • Onsite

About The Position

This position provides leadership and strategic direction for the Parenteral Manufacturing Technical Services/Manufacturing Science (TS/MS) organization. This includes management and governance of the technical agenda, support of the deviation and change control quality systems, ownership of operations batch records and applicable standard operating procedures, product/process monitoring, documenting, and maintaining product control strategies including risk assessments and documenting and maintaining the state of process/sterility assurance/cleaning validation.

Requirements

• 10+ years of prior leadership experience leading in parenteral manufacturing technical services
• Demonstrated regulatory inspection experience interacting with regulators directly
• B.S. or equivalent in a scientific field of study

Nice To Haves

• Understanding of manufacturing and cGMPs
• Ability to prioritize efforts
• Effective written and oral communication skills
• Effective interpersonal skills
• Involvement in external pharmaceutical industry associations

Responsibilities

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Provide strategic direction to TS/MS organization
• Provide leadership and governance to the technical/scientific agenda for the site via the Science Lead Team (process monitoring)
• Represent the TS/MS organization at the Site Lead Team
• Develop administrative and technical leadership with the organization
• Assure that appropriately trained and qualified staff are in place to provide day to day support and project support for new and existing products
• Process monitoring for continuous improvement of control strategy, risk reduction, maintenance of the validated state and for manufacturing productivity
• Establish reward and recognition initiatives for staff
• Communicate effectively with Parenteral TS/MS Network Director and other Parenteral TS/MS leaders to ensure alignment of technical agenda and Central TS/MS initiatives for molecule, sterility, and components.
• Serve as a key technical resource for regulatory interactions
• Manage commercialization agenda in partnership with PR&D and central TS/MS.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 5,001-10,000 employees