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.
This role is responsible to lead the technical service primary loop team responsible to provide technical oversight of the technical activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards.
This role is responsible of both technical excellence and compliance while meeting deliverables for day to day operation on making and supply medicines and new product commercialization.
Has responsibility for ensuring all products are manufactured according to a validated process, following the approved control strategy and maintaining in a validated state during the product cycle.
Responsibilities:
Make & Supply Medicine ?
Provide oversight to ensure reliable supply of medicines through effective and efficient manufacturing process.??
Ensure capable and in control processes at CMs. Establish and maintain robust control strategy for all manufacturing/packaging/distribution operation and those meet the Lilly standards/expectations.
Ensure process definition of critical parameters are in alignment with regulatory submission.
Ensure that each of the department and external partner operate in compliance with cGMPs, regulatory commitments and Lilly Functional Standards though appropriate oversight. Ensure inspection readiness at all times.?
Ensure Quality of the externally manufactured products through appropriate oversight, CAPAs, metrics and monitoring systems.?
Build relationships with CMs to ensure alignment of intents and objectives. ?
Validation: ensure proper definition of strategies, revisions, protocol approvals, validation plans, final reports and master plan. Approve strategy documents and applicable protocols.
Change Control: Properly evaluate and assess impact of proposed changes to validated processes, regulations, relationship and regulatory commitments.?
Deviations: Properly evaluate impact on product and processes. Properly evaluate impact on validated process and the control strategy. Ensure proper root cause identification and establishment of effective corrective action plans to prevent reoccurrence.
Ensure investigations are completed in an appropriated and timely fashion.
APR, ARs and OPVs: Ensure that all process reviews are conducted and all identified or changes are completed in a timely manner and in compliance with applicable standards.
Ensure External Manufacturing documentation (e.g., Quality Agreements, Manufacturing Requirements Document, validation documents) is in place and in compliance.?
Build relationships externally to Lilly to create benchmark opportunities and identify best practices.??
Oversees the execution of the technical agenda and each external partner, in line with business plan (BP), cGMPs and internal standards.
Escalate to Sr. Management in a timely fashion risks to supply, manufacturing issues, major deviations 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 incorporate in the CMs technical agenda. ?
New CMs ?
Contribute to CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options (if applicable).?
Governance ?
Be a member of the Flow Team and Science Lead Team (LT), Site Quality LT.?
Support the functional Business plan and participate in the DPEM BP consolidation. Ensure the BP implementation within the established targets.?
Establish effective networking with internal stakeholders and ensure alignment with central TS/MS and development.
Partner with Joint Process Team (JPT) Leader, Quality Managers and Secondary Loop to ensure TS/MS members of the JPT complete actions/objectives.
People
Provide adequate staffing to meet the technical agenda, as well as the functional agenda?
Lead the performance management (PM) process by overseeing development of employee PM plans; conduct interim and final reviews.
Coach, develop and provide feedback to members of the team.?
Support diversity in recruiting and development of team members. Lead recognition, merit pay, and promotion decisions. ?
Support Technical talent assessment and succession planning activities. ?
Actively recruit and onboard new resources for the team.
Effectively encourage knowledge sharing and education within team and with key internal partners: Operations, Quality Assurance, Supply Chain and the corresponding Networks at the TS/MS Central Team.?
Effectively encourage knowledge sharing and education with the external partners?
Develop and grow the technical ability to be consistent with Drug Product External Manufacturing (DPEM) business needs for the supportedPlatform?
Relationships
All functions at the contract manufacturers from senior management to shop floor personnel.
Lilly Affiliate personnel and senior Country and Area management.
Lilly TS/MS, QA, Auditing groups, Laboratories at Lilly sites, US and European Manufacturing sites.
Senior TS/MS management, Product and Technical leaders, development scientists, CMC PMs and molecule stewards.
Basic Requirements
Bachelors Degree in Pharmacy, Chemistry, Engineering, or similarly related fields.
5+ years' experience in pharmaceutical manufacturing in technical services and/or quality.
Previous leadership experience.
Additional Preferences
Knowledge and ability to apply basic statistical tools.
Regulatory related experience.
Established technical, quality, and internal networks.
Prior experience supporting drug product parenteral manufacturing.
A thorough understanding of cGMPs and drug product manufacturing.
Good communication skills, especially attention to detail in written procedures and protocol development.
High degree of technical curiosity and critical thinking.
High learning agility.
Strong leadership, interpersonal and teamwork skills, able to work effectively in a team environment.
Use of data and science to support decisions.
Willingness to learn new technologies.
Capability to work in a virtual and complex environment.
Willingness to travel.
Appreciation for cultural diversity.
Other information
Shift is days, but off hours may be necessary to support operations.
Travel is possible, up to 30%.
This is not a remote position and would require relocation to a Lilly site.
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
$123,000 - $180,400
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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