Senior Director API EM TS/MS – Large Molecule
Lilly
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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
Organization Overview:
The Senior Director API EM TS/MS – Large Molecule serves as the local advocate for the TS/MS function to manage the technical aspects of the LM API External Manufacturing and develop a technical agenda based on sound scientific principles driving towards predictable and robust process metrics. This position expands and challenges technical staff to develop and deliver programs for continuous process optimization and improvement.
Technology that is consider large molecule include: mAbs, ecoli, conjugated mAbs, gene therapy, cell therapy.
The Senior Director API EM TS/MS – Large Molecule will help develop and evolve the strategic direction, organizational capability, and management of the organization to achieve long-term business objectives as well as continuously develop the business, in the context of corporate objectives and the continuously changing external environment.
This position will manage issues that span multiple functions in the organization and extends to broader corporate/external influence. Additionally, the EM TS/MS leader is accountable for helping achieve the organizational Business Plan, including all functional objectives.
Responsibilities:
Key Objectives/Deliverables:
+ Provide technical oversight and stewardship for API operations, assisting in resolution of technical issues associated with products outsourced.
+ Ensure staff is qualified and that all required training of technical services personnel is completed. Training should be adapted to the individual needs of each employee to ensure appropriate support to operations, across technology platforms and molecules.
+ Build and maintain relationship with the development organization
+ Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications) in a process flow document (PFD).
+ Ensure strong scientific leadership is in place at the plant in accordance with the TS/MS guideline Site and Network TS/MS Capabilities.
+ Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
+ Develop and steward site operational control strategies and ensure their implementation is consistent with MSOE 302 — Operational Control Strategy in Manufacturing.
+ Influence and implement the network technical agenda and drive continuous improvement within a multi-discipline technical environment.
+ Lead the Science Lead Team and ensure it complies with the expectations established in MSOE 601 — Manufacturing Site and Plant Governance.
+ Work with Operations counterpart to help Lead required Flow teams / plant lead team, complying with the expectations established in MSOE 601- Manufacturing Site and Plant Governance.
+ Serve as an active member of the Commercialization Lead Team. Ensure effective integration of the TS/MS organization with site functions, global function/network, and with appropriate external stakeholders.
Basic Requirements:
High-quality skills to include: scientific knowledge, data analysis, ability to prioritize, attention to detail, written and oral communication, critical decision-making, interpersonal/people, computer applications, complex problem solving, mentoring/leadership; self-motivation, clear understanding of all cGMPs, policies, procedures, and guidelines, and ensuring a fair, equitable, and safe work environment.
Bachelor's higher or equivalent experience in the scientific disciplines of Biochemistry, Organic Chemistry, Physical Chemistry, Analytical Chemistry, or Chemical Engineering, Engineering.
Additional Information:
Some travel will be required up to 15% of time
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 an EEO/Affirmative Action Employer and 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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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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