Senior Director

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

Job Description

Bioproduct Research and Development is seeking a Senior Director to lead the Drug Product Development Department, responsible for biopharmaceutical design, formulation, process development, tech transfer, and registration of all parenteral drug products (e.g. antibodies, bioconjugates, bispecific antibodies, recombinant proteins, peptides and genetic medicines). In this role, you will support the formulation scientists and process engineers deliver on portfolio assets in early and late phases of clinical development and will instill best practices for phase appropriate commercialization activities (i.e. study design, report template, regulatory submissions, etc). You will also support building bridges between discovery, manufacturing and other partner functions to ensure successful development and commercialization of all parenteral products. You will also work with scientists to implement platform and foundational research activities at the Indianapolis and Cambridge MA sites.

Key Responsibilities

• Lead the formulation and process development group to enable development, tech transfer, commercialization and registration of the Lilly parenteral portfolio.
• Provide business leadership by setting the strategic direction for the department and ensuring implementation to support the portfolio and meet the organizational objectives.
• Ensure compliance of the departmental operations with laws, regulations, and practices governing the development of new drugs for use in humans. Instill quality culture and be actively involved in any audits if needed.
• Collaborate and integrate with leaders in other departments to ensure business effectiveness of BR&D, all development orgs, and large molecule network.
• Ensure cross-functional collaboration within BR&D and with discovery and other development functions as new modalities are added to the clinical portfolio.
• 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 discovery investment and manufacturing needs.
• Demonstrate leadership behaviors and accountability. Develop talents at all levels and perform succession planning. Ensure appropriate coaching/performance management.
• 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 prioritize and direct resources to meet the changes in portfolio demand. 
• Collaborate and integrate with leaders in other departments to ensure business effectiveness of BR&D, development, and large molecule network.
• Champion/support BR&D and corporate initiatives as appropriate

Requirements

• Ph.D in Pharmaceutical Sciences, Pharmaceutical Chemistry, Chemical Engineering , Biochemistry, Chemical Engineering, or related fields, with a minimum of 10 years of pharmaceutical industry experience, or BS with minimum 18 years of applicable experience

Additional Skills/preferences

• Thorough knowledge and experience in bioproduct development (e.g. from candidate selection to submission). 
• Knowledge of GMP, GLPs, and regulatory requirements is a must to ensure the efficient movement of projects through development to successful product registration (e.g. Authorship of IND/ BLA, etc).
• Excellent communication, interpersonal, and strong leadership skills are essential.
• The individual must have demonstrated capability to work effectively with business partners and/or customers with an ability to stay on top of entire bioproduct portfolio

Other Information

• Location: Indianapolis
• Travel requirement: less than 25%
• No work shifts required

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