Technical Project Leader - Biopharmaceutical Product Development

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Position Description

The Technical Project Leader (TPL) plays a central role in enabling and driving the CMC development of biopharmaceuticals and biologics for veterinary medicines by guiding & coordinating work at our CDMO partners in India and partnering, aligning and consulting with members of Elanco Technical Development functions (subject matter experts and leaders), Research or Development Project Team members, Manufacturing & Quality and Regulatory CMC.

Functions, Duties, Tasks

Leadership

• Lead the technical team comprising of representatives from Technical Development (TD) functions, Manufacturing & Quality, and Regulatory CMC
• Influence, support, and ensure implementation of decisions and strategies agreed by the project team.
• Effectively align project objectives and priorities with technical team members, project teams, TD, and external partners to achieve overall project deliverables.
• Proactively communicate progress, key issues, and any other critical topics in a timely manner to TD, appropriate management level, and stakeholders.
• Create an innovative culture / ensure co-operation and communication between technical functional experts.

Technical Expertise

• Oversee, coordinate and guide CMC development work (process, formulation, analytical – drug substance & drug product) at external CDMO partners.
• Represent all technical functions at the development project team and provide scientific and technical expertise and quality awareness.
• Ensure compliance with internal governance, stage gate review deliverables and other relevant procedures.
• Partner, collaborate, consult, and align external work program with internal subject matter experts and Technical Development / R&D leaders.
• Support preparation of regulatory CMC technical sections in partnership with Regulatory CMC/Innovation and functional technical contributors.

Project Management Skills

• Steer the definition of a scientifically and technically sound (including risk assessments as appropriate), business driven technical development strategy for the development and life cycle management of products as a core member of a project team and the leader of the technical team.
• Provide information to facilitate accurate and timely project budget forecasts and resourcing.
• Manage and support line functions to deliver objectives in a high quality, timely, cost-effective manner.
• Ensure timely delivery of research/clinical material for project studies according to required quality standard.

Minimum Qualification (education, experience and/or training, required certifications):

• MSc/PhD in a related field with at least 10 years of relevant experience in biopharmaceutical product development and an excellent understanding of the technical development process for a monoclonal antibody.
• Proven Knowledge of USDA, FDA & EMA guidelines for monoclonal antibodies and good understanding of the regulatory (CMC) requirements for veterinary products as well as GMP.
• Demonstrated effectiveness in Project Management, including technical transfers.
• Advanced leadership, drug development, quality management and communication/teamwork skills.
• At least intermediate competency in people management, strategic thinking, regulatory expertise, and manufacturing and control strategies. Computer literacy (e.g. MS Office, MS Project,).
• Languages: excellent English required (oral & written)

Elanco 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