Director - Engineering - Purification & Conjugation Technologies - BR&D

The Bioprocess Biologics Operations team within Bioproduct Research and Development (BRD) is responsible for the GMP manufacture of drug substance (DS) to support clinical trials within the BRD portfolio. This includes the internal manufacture of monoclonal antibodies, bioconjugates, and adeno‑associated viruses, as well as oversight of DS manufacturing at qualified collaboration partners. The technical director of engineering will consult with process development and manufacturing network partners to ensure facility fit for process technical transfers, advise on new manufacturing facility designs, and implement new technology.

The main focus area of this role is purification and conjugation technologies in support of GMP manufacturing.

• Provide technical expertise and oversight to assist in the design and operation of manufacturing processes for drug substance, with a focus on chromatography, filtration and bulk unit operations (large scale).
• Develop control systems for unit operations and process improvements.
• Perform impact and risk assessments for new processes, unit operations and technology.
• Collaborate with development scientists and commercial manufacturing to ensure that technology adoption and integration is aligned to strategies of the broader organization.
• Maintain awareness of new and developing technologies to evaluate and implement, as required, that enhance current capabilities and align with commercial manufacturing needs.
• Provide engineering support for tech transfers to internal and external manufacturing (commercial and clinical) sites, as required.
• Teach, mentor and ensure knowledge transfer to other engineers and scientists within the organization.
• Ensure processing equipment and technology remain compliant with PR&D Quality System requirements, applicable engineering standards, and cGMP requirements.
• Provide technical input and impact assessment for global and local Quality Standards and SOPs, as requested.
• Participate in audits (internal and external), as requested.
• Support regulatory submissions and response to questions, as requested.

• Ph.D. in Chemical Engineering or a related field with more than 8 years of experience in process development or biologics manufacturing, OR a BS/MS in Chemical Engineering or a related field with 10–12+ years of experience.
• Strong experience in biopharmaceutical production unit operations for downstream processing.
• Experience in design and qualification of downstream equipment.
• Strong oral and written communication skills with the ability to communicate across a wide variety of audiences, e.g., technical personnel, operations, and management.
• Strong problem‑solving skills.
• Ability to provide technical leadership across diverse teams.
• Experience with process control systems like Unicorn or Delta
  
  V.

• Position is 8 hour days with flexibility to support activities during shutdowns, weekends, etc.
• Travel is possible but expected to be minimal.

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

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

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form found at  for further assistance.

Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The…