Director-Cell Culture/Molecular Biology/Fermentation

Employer
Lilly
Location
Indiana
Salary
Competitive
Posted
September 13 2018
Ref
44499BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
Lead the department for the cell line and cell culture research & development, tech transfer, and registration of bioproduct projects. These responsibilities include but not limit to embracing new technologies, enhancing current CHO platform technology, instilling best practices for phase appropriate commercialization activities (i.e. study design, report template, etc), aligning & sharing cell culture platform across development and manufacturing network, and ensuring successful registration and regulatory submissions. 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 the strategic direction for the department 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 (i.e. QbD, and integrated control strategy)
  • Proactively manage and direct resources to meet the changes in portfolio prioritization and demand. Own the functional forecast
  • Collaborate with leaders in other departments 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 to ensure best practices and development model is applied to the early phase assets

Company Overview
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.

Basic Qualifications
  • 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.

Additional Skills/Preferences
  • 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.

Additional Information
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.

Similar jobs

Similar jobs