Advisor​/Senior Advisor Downstream Purification Development

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Bioproduct Research and Development (BRD) is the large-molecule process development organization within Lilly. BRD is responsible for material and data generation to support clinical trials and commercialization of biologic therapeutics such as mAbs and bioconjugates. Our team works to accelerate the development and manufacturing of new bioconjugate medicines for our patients. We perform innovative and cutting-edge research to deliver bioconjugation processes, knowledge, and best practices to support clinical trials and commercialization for antibody-drug conjugates (ADCs), antibody-peptide conjugates (APCs), and antibody-RNA conjugates (ARCs/AOCs).

We collaborate with our Synthetic Molecule Design and Development (SMDD), discovery, and biologics development colleagues to advance this exciting class of new drugs and seek fundamental learning and platform approaches to their development.

The scientist is responsible for leading teams of scientists and engineers in the development and optimization of purification processes for the production of recombinant therapeutic proteins as well as for process control strategy development, process scale-up and technology transfer to pilot plant and manufacturing sites. The scientist is also responsible for leading/supporting organizational strategic initiatives, evaluating and/or installing new capabilities/technologies and leveraging internal and external influence to solve problems and benchmark potential solutions.

• Lead the design, execution and interpretation of appropriate purification development experiments to drive the definition and optimization of downstream processes for the generation of recombinant protein active pharmaceutical ingredients.
• Use first principles and designed experiments (DOE) to predict/understand/control the impact of physical and chemical processing conditions on recombinant protein product quality.
• Lead the development of validated scaled-down models of key bioprocess unit operations including: filtration/TFF, chromatography operations and freeze/thaw.
• Participate in and/or lead cross-functional process development teams and effectively collaborate with other groups in Bioprocess and Bioproduct Development, Discovery, Technical services for Manufacturing and Manufacturing.
• Support transfer of purification processes to Technical services for Manufacturing laboratories and pilot plant/manufacturing sites.
• Authorship of technical reports and regulatory documents.
• Work effectively with external parties on development projects, research collaborations and outsourcing efforts.
• Lead/support implementation of organizational strategic initiatives in support of the Lilly pipeline.
• Keep abreast of relevant scientific literature and new technologies/capabilities and regulatory initiatives/requirements. Lead implementation, as appropriate.
• Leverage internal and external influence to solve problems and benchmark potential solutions.
• Provide coaching, training and administration of performance management to personnel (primarily, but not limited to, direct reports).
• Ensure work and team activities are aligned with all relevant Development Quality, regulatory, HSE, GLP and GMP requirements.

• Ph.D. in Biochemistry, Chemistry, or related field.
• General knowledge and understanding of issues associated with scaling of protein purification processes and use of statistics for data analysis.

• Exceptional problem solving and decision-making skills.
• Demonstration of scientific and people leadership skills.
• Effective oral and written communication skills.
• Must be able to work productively in an interdisciplinary team environment.

The physical demands of this job are consistent with a lab environment.

This position’s work environment is in a laboratory environment.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender…