Associate Director Validation Jobs in Indiana (NOW HIRING)

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The Associate Director - Technical Services/Manufacturing Science (TS/MS) Dry Products External Manufacturing (Dry EM) is responsible for managing the activities of TS/MS and ENG personnel supporting the oversight of external manufacture of dry products. The Assoc. Director TSMS must balance coaching a technical and engineering staff, prioritization and staffing for routine production support activities, implementation of technical projects, technical transfers, commercialization, process optimizations and engineering activities oversight. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation and engineering practices. The position requires working cross-functionally within sites, network, commercialization teams, and multiple global contract manufacturers to deliver on technical /engineering 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 , ENG 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 and Engineering 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 risks 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
• Ensure JPT objectives and priorities are delivered and issues escalated.
• Support financial planning and reporting for Dry EM.

Relationships:

• TS/MS, ENG 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

• Bachelor`s Degree in scientific disciplines of Chemistry, Biology, Biotechnology, Pharmacy, Engineering or another related field.
• 8+ years' experience in Dry Products/Oral Solid Dose pharmaceutical manufacturing environment in any of the following associated disciplines:TSMS, Production, Engineering at a manufacturing site .
• Previous leadership/people management experience.

Additional Skills/ Preferences

• Ability to represent Eli Lillys 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

• ~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 (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

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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