Associate Director - Small Molecule Technical Services & Manufacturing Science, Api External Ma[...]

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 39,000 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.

#WeAreLilly

Overview

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 39,000 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.

#WeAreLilly

Responsibilities

Associate Director – Technical Services / Manufacturing Science (TSMS) API External Manufacturing is responsible for managing the activities of TSMS personnel supporting the oversight of externally manufactured Small Molecules.

The Associate 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 optimization.

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 suppliers to deliver on technical objectives, specific product business plan, and quality objectives.

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 technical staff.

Partner within TSMS and other functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.

Interact with suppliers, 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.

Ensure adequate oversight for technical projects 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.

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.

Basic Qualifications

Bachelor's Degree in scientific disciplines of Chemistry, Pharmacy, Engineering or other related field.

Prefer at least five years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines : TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement.

Additional Skills / Preferences

Responsible for maintaining a safe work environment

Ability to influence and lead diverse groups

Influences complex regulatory, 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

Demonstrated Project Management skills and ability to 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

Additional Information

10 – 20% travel may be required

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

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 at 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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