Associate Director – TS/MS Validation

Job description

At Lilly, we unite caring with discovery to make life better for people around the world.

We are a global healthcare leader headquartered in Indianapolis, Indiana.

Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

**Responsibilities:**

The Associate Director, Validation is responsible for staffing, training, and leadership of the Technical Services/Manufacturing Science TS/MS validation group.

The specific area of responsibility includes cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and the qualification of equipment, facilities, and utilities.

The Associate Director may also provide input/guidance/oversight to the performance of other validation types at the site as needed.

The Associate Director will be responsible for supporting the day-to-day TS/MS validation activities as well as planning for the 3-6-month horizon.

**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, with a focus on supporting the areas of cleaning validation, sterilization validation, filter validation, controlled temperature storage qualification, and the qualification of equipment, facilities, and utilities.
+ 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.
+ Manage external contracts/resources and project management resources, as needed.
+ Manage the development and maintenance of relevant validation program documents including SOPs and Master Plans.
+ Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation master plans, protocols and summary reports, etc.
+ Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.
+ Work within or lead cross-functional teams in positive fashion to implement TS/MS validation 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.

**Basic Qualifications:**

+ BS, MS, or Doctorate in Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
+ Minimum 1 year of management or leadership experience, including leading or working effectively with a cross functional group
+ Minimum 5 years of regulated industry experience
+ Previous experience with aseptic manufacturing

**Additional Skills/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, EMEA, and OSHA.
+ Experience supporting cGMP manufacturing (specifically within operations, technical services/MSAT, quality assurance, etc.)
+ Previous facility or area start up experience
+ Previous equipment qualification and process validation experience
+ Previous experience with highly automated equipment
+ Previous experience with deviation and change management systems including MasterControl

**Additional Information:**

+ Role is Monday through Friday based.

Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.).

Occasional extended hours and/or off-hour work may be required

This job description is intended to provide a general overview of the job requirements at the time it was prepared.

The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

For GMP purposes, the job description should be updated for significant changes.

As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance.

Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.

Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).

Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is

$118,500 - $173,800

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

Required Skill Profession

Other General