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

About the role

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.

Responsibilities

• 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.
• Utilize a holistic understanding of process operations, engineering fundamentals, and cGMP requirements to provide leadership and technical oversight for the design, implementation, and lifecycle management for the process equipment within the Bioprocess Pilot Plant.
• 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.
• Support regulatory submissions and response to questions, as requested.

Requirements

• Ph.D. in Chemical Engineering or a related field with 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 in process development or biologics manufacturing.
• Strong experience in biopharmaceutical production unit operations for downstream processing.
• Design and qualification of downstream equipment.
• Strong oral and written communication skills with a demonstrated ability to communicate across a wide variety of audiences, e.g., technical personnel, operations, and management.
• Strong problem-solving skills.
• Able to provide technical leadership across diverse teams.

Qualifications

• Ability to provide technical leadership across diverse teams.

Skills

• Ability to provide technical leadership across diverse teams.

Benefits

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

Physical Demands/Travel

The physical demands of this job are consistent with a manufacturing environment. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Work Environment This position’s work environment is in a manufacturing environment.