Associate Director - TSMS Dry External Manufacturing

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.

Organization Overview :

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities

The Associate Director – Technical Services / Manufacturing Science (TS / MS) Dry Products External Manufacturing (Dry EM) is responsible for managing the activities of TS / MS personnel supporting the oversight of external manufacture of dry products. The Assoc. Director TSMS must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, technical transfers, commercialization and process optimizations.  The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate / industry standards for validation.  The position requires working cross-functionally within the site, network, commercialization teams, and multiple global contract manufacturers to deliver on technical objectives, specific product business plan, and quality objectives.

Key Objectives / Deliverables

Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.

Performance management and development of staff.

Partner within TS / MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, functional objectives, and GMP Quality Plan objectives

Ensure appropriate technical oversight and stewardship of oral solid dose form manufacturing and packaging including drug product intermediates (e.g. spray dried dispersions / amorphous solid dispersions).

Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits

Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and / or productivity for all products within the site portfolio.

Ensure adequate oversight and technical excellence for investigations and complaints including CAPA and monitoring improvement.

Ensure adequate oversight for technical projects / technical agenda to improve process control, capacity, yield, quality.

Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.

Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.

Build relationships external to Lilly to create benchmarks opportunities and identify best practices.

Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.

Escalate to Sr. Leaders in a timely fashion risk to supply, manufacturing issues major deviations, critical complaints or safety and cybersecurity issues.

Lead implementation and execution of activities aligned with emerging need related to process improvement, control strategy or new regulation and ensure any emerging need is incorporated into the CMs technical agenda.

General

Contribute to CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options.

Contribute to Business Plan and Strategic Plan processes

Serve as cross-functional member on DryEM Lead Team

Partner with JPT Leaders, QA and, Regulatory and Supply Chain together with broader Dry EM leaders to ensure JPT objectives and priorities are delivered and issues escalated.

Support financial planning and reporting for Dry EM.

Relationships

TS / MS functions at other Lilly locations (e.g. Lilly plant sites and central TS / MS).

All relevant functions within external manufacturers.

Internal Manufacturing Nodes (PR01, Alcobendas)

Dry EM team

API-EM group.

External Manufacturing Organizations.

Lilly GQAAC

Lilly Global Supply Chain functions.

Lilly Teach @ Lilly functions.

Lilly Geneva and IHL Kinsale (if required) .

Lilly External Manufacturing Support Teams

Basic Qualifications :

Education :

Bachelor`s Degree in scientific disciplines of Chemistry, Biology, Biotechnology, Pharmacy, Engineering or another related field.

Experience :

7+ years’ experience in Dry Products / Oral Solid Dose pharmaceutical manufacturing environment in any of the following associated disciplines :  TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development.

Previous leadership / people management experience.

Additional Skills / Preferences

Ability to represent Eli Lilly´s mission, policies and practices in a positive, professional and ethical manner to influence CMs.

Responsible for maintaining a safe work environment

Ability to influence and inclusively lead diverse groups

Influences complex regulatory / quality, business, or technical issues within the site and function

Experience in statistics

Technical leadership, administrative and organizational skills

Builds relationships with internal and external customers and partners

Proficiency in delivering highly complex tasks and / or tasks that are highly cross-functional

Ability to manage / lead coordinate complex projects

Strong analytical and quantitative problem-solving skills

Ability to communicate and influence effectively across functional groups and stakeholders

Strategic thinking and ability to balance short term needs with long term business evolution

Enthusiasm for changes, team spirit and flexibility

Demonstrated ability to learn & apply technical / scientific knowledge

Capability to work in a virtual and complex environment

Additional Information

~20-30% travel may be required

Some off-shift work (night / weekend) may be required to support 24 / 7 operations across global networks

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 (

• ) 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 - $191,400

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.

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