Director - Manufacturing Science
4 months ago
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.
The mission of Technical Services/Manufacturing Science (TS/MS) is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow. The Parenteral drug product network TSMS provides product stewardship for all parenteral products across multiple manufacturing sites.
Responsibilities:
In this individual contributor position as a Global Product Steward scientist role, you will have the ability to collaborate with multi-functional teams across Lilly and external manufacturing organizations. As an individual contributor, you will work side by side with other Lilly professionals to drive the drug product technical agenda, including the exciting journey of new pipeline products from development into manufacturing.
Provide technical stewardship of parenteral drug products.
Collaborate with multi-functional team to support global parenteral manufacturing sites for new product commercialization, process improvements and technology transfers at internal and external manufacturing sites.
Collaborate with process engineers and development scientists to craft and transfer robust manufacturing processes to commercial and third-party manufacturing operations. This includes serving as a liaison to CM&C teams to shepherd new pipeline products from development into manufacturing.
Craft and complete vital laboratory and pilot studies, as well as prepare technical reports and/or regulatory submissions to support business objectives.
Use and influence the internal and external scientific community to impact Lilly’s ability to commercialize life-changing medicines, improve productivity, and build long-term value.
Suggest and evaluate areas for molecule, product, and business process improvement. This includes driving the molecule/product technical agenda with a specific focus on process/productivity improvements in partnership with the global manufacturing sites.
Act with speed, agility, and decisiveness to identify the critical issues to resolve; influences team and/or stakeholders on the critical risks and plan for resolution.
Champion changes that increase the effectiveness of overall business objectives
Coach and mentor junior associates.
Basic Qualifications:
A degree in relevant area such as Biochemistry, Chemistry, Chemical Engineering, Biology or Pharmaceutical Science with one of the following:
PhD degree with 10 years of practical experience of parenteral product manufacturing or
Master’s degree with 15 years of practical experience of parenteral product manufacturing or
Bachelor’s degree with 20 years of practical experience of parenteral product manufacturing
Proficient in biomolecule characterization and product development with substantial experience in GMP manufacturing.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Skills/Preferences:
Demonstrated examples of leadership, influence, and problem-solving skills.
Ability to analyze and interpret sophisticated technical data and solve data issues.
Strong written and oral communication skills.
Preparation, review, and response preparation of global regulatory submissions i.e. BLAs and NDAs and other technical communications.
Ability to Leadership teams to successfully deliver projects on time and in scope.
Working knowledge of statistical design of experiments and analysis.
Working knowledge and scientific understanding of product distribution, drug delivery devices and advanced drug delivery systems.
Additional Information:
Recognition and future promotion on the Technical Ladder
10-20% domestic and international travel
Position may be based in Indianapolis, IN or at one of Lilly's parenteral manufacturing sites.
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
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
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