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 Technical Service/Manufacturing Science (TSMS) Representative of Drug Products External Manufacturing (DPEM) Commercialization is responsible for providing technical support to commercialization activities within DPEM. DPEM is responsible for the commercialization of drug products (DPs) at selected contract manufacturers (CMs) located globally.
The scope of the role includes technical support for all commercialization assets. A key part of this role is supporting each commercialization project to ensure consistency in approach and processes, up through and including submission.
The DPEM TSMS Commercialization Representative is also responsible for providing process oversight, according to the product control strategy and governing documentation, to ensure the appropriate handover to the commercial manufacturing unit
Key Objectives/Deliverables:
The DPEM TSMS Commercialization Representative, under the technical guidance provided by DPEM Technical Lead, provides support to commercialize new products into CMs as follows:
Understanding of the scientific principles required for manufacturing DPs, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
Understanding of secondary packaging and device assembly processes.
Preparation and contribution or review of commercialization deliverables (e.g. change controls, Tech Transfer Plans, PFMEA, risk assessments, etc., as required.
Support in writing and implementing new SOPs according the DPEM requirements and cGMPs.
Guarantee the technical transfer process parameter such as critical and operational process parameters, in-process controls and specifications are followed.
Serves as technical support interface between CM and DPEM.
Provide support for the execution of activities and key commercialization deliverables (such as PV protocol, technical and engineering studies, demo batch protocols) to enable batch manufacture and tech transfer activities of drug products.
If required, provide technical support for technical investigations and CAPAs, as needed.
Support collecting the data to support regulatory submission requirements.
Assist the process monitoring implementation to monitor process variability and capability.
Be able to identify/document/assess potential issues.
Ensure that all transfer docs are aligned and consistent agreeing with the PFD describing the manufacturing process, including product and operational control strategies.
Transition with DPEM primary and secondary loop organizations according to the handover plan.
Relationships:
Contract Manufacturing leadership and functions.
All relevant functions at the Lilly Networks (such as M&Q central functions, Product Development and Regulatory Affairs).
DPEM and Lilly External Manufacturing teams (API, IDM).
Educational Requirements:
Bachelor's degree or higher in a science-related field such as Pharmacy, Chemistry, Engineering, Biological Sciences, or related Life Sciences.
Professional Experience:
Over 5 years of experience in parenteral manufacturing.
Proficiency in Drug Product (DP) manufacturing technologies and processes.
Proven track record in DP technical transfers and the commercialization of new drug products.
Expertise in the qualification of DP manufacturing equipment, utilities, and facilities
Additional Skills/ Preferences
Self-management and organizational skills to produce quality deliverables within established time frames.
Demonstrated ability of collaboration to operate cross functionally and hold technical/process discussions with third parties.
A thorough understanding of cGMPs.
Additional Information
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
$64,500 - $167,200
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.