Senior/Principal Scientist, Bioprocess Purification Development

About the role

The scientist is responsible for downstream purification development activities related to the production of bioproduct active pharmaceutical ingredients including purification process definition and optimization, process robustness studies, process transfers to pilot plant and manufacturing sites and authorship of downstream process development sections of regulatory submissions. The incumbent will interact closely with other scientists in Bioprocess/Bioproduct Development as well as Discovery, Technical services for Manufacturing, and Manufacturing scientists. They are expected to be an integral participant on multidisciplinary CMC project teams that provide support for bioproduct process and product development activities.

Responsibilities

• Design, execute and interpret appropriate purification development experiments for generation of bioproduct active pharmaceutical ingredient.
• Participate in 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 pilot plant and manufacturing sites.
• Author technical reports and regulatory documents.
• Work effectively with external parties on development projects, research collaborations and outsourcing efforts.
• Support organizational initiatives, as appropriate
• Keep abreast of relevant scientific literature, new technologies/capabilities and regulatory initiatives/requirements and support their implementation, as appropriate.
• Supervision of personnel and coaching, training and administration of performance management to personnel, where assigned.
• Ensure work is aligned with all relevant Development Quality, Regulatory, HSE, GLP and GMP requirements.

Basic Requirements

• BS or MS degree in Chemical Engineering, Biochemistry, Chemistry or related field with 5+ years (BS) or 2+ years (MS) of direct related industry experience.
• PhD will not be considered at this job level.
• Biochemistry experience with some knowledge of protein chemistry and protein purification
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• Capable of independently designing experiments (experience with use of statistical design of experiments (DOE) is desirable), generating data, interpreting results and documenting work in laboratory notebooks and technical reports.
• Effective oral and written communication skills, self-management, task planning and organization.
• Must be able to work productively in a multidisciplinary team environment.

Pay

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $79,500 - $116,600. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).