Lilly Director-Mol Biol/Ferm/Cell Cult in Indianapolis, Indiana
The Bioproduct Research and Development organization strives to deliver creative medicines to patients through the development and commercialization of insulins, monoclonal antibodies, novel therapeutic proteins, peptides etc. This organization is a multidisciplinary group that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, scientists have full access to our scientific excellence and engineering capabilities.
We are seeking a Director of Cell Culture/Molecular Biology/Fermentation to lead a talent group to develop cell line, cell culture and fermentation processes, to tech transfer, and to register bioproducts. This role will allow you to embrace new technologies, enhancing current CHO platform technology, instilling best practices for phase appropriate commercialization activities and ensuring successful regulatory submissions. You will also lead the department to enable new modalities development from internal and external research.
Ensure compliance of the departmental operations with laws, regulations, and practices governing the development of new drugs for use in humans. Monitor project progress; ensure compliance with agreed timetables.
Ensure maintenance of the development laboratories, with specific attention to safety in the workplace.
Perform technology assessment and incorporation of new technology so that platform remains competitive and aligned with manufacturing needs.
Provide business leadership for Molecular Biology, Fermentation, and Cell Culture by setting strategic direction and ensuring implementation to support the pipeline and meet the organizational objectives
Ensure that the department keeps current with scientific literature/new technology/capabilities and regulatory initiatives/requirements and their implementation, as appropriate.
Manage and direct resources to meet the changes in portfolio prioritization and demand. Own the functional forecast
Collaborate with leaders in other groups to ensure business effectiveness and champion/support corporate initiatives as appropriate
Demonstrate and insist on leadership behaviors. Develop talents at all levels. Ensure appropriate performance management and perform succession planning for the department
Forge strong relationship with Discovery and Manufacturing to ensure best practices and development model are applied
Develop strategies to enable novel modalities from both internal and external research
Excellent communication, interpersonal, and leadership skills.
Thorough knowledge and experience in bioproduct development.
Demonstrated capability to work effectively with business partners and/or customers and has the ability to navigate through complex business and technical issues.
Knowledge of GMP, GLPs, and regulatory requirements is necessary to ensure the efficient movement of projects through development to successful product registration.
Knowledge of the latest biotechnology to drive department innovation direction.
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.
Director-Cell Culture/Molecular Biology/Fermentation
PhD in Biochemistry, Engineering, or Life Sciences, with a minimum of 8 years of pharmaceutical experience in bioprocess development; or BS/MS degrees with 15 years of applicable experience.
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.
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 39,000 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.
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