Process Manager - Downstream Process Development

Duties And Responsibilities

• Develop scale-able and robust downstream processes for clinical and commercial GMP manufacturing.
• Design experiments related to development, optimization, scale-up of all steps of various recombinant protein formats (e.g., antibodies, bispecific and enzymes) inclusive of viral clearance studies.
• Lead lab team members in the execution of experiments.
• Apply DoE and other advanced statistical techniques to design and evaluate late-stage development activities and process characterization studies in preparation for process qualification and validation at manufacturing scale.
• Define the control strategy for commercial manufacturing.
• Interface with clients.
• Analyze, prepare, and formally present data.
• Author and collaborate on client-approved documents.
• Provide technical consulting as a Subject Matter Expert.
• Transfer programs to Manufacturing.
• Provide process descriptions and gap analyses.
• Collaborate with MSAT on change controls, deviations, and investigations.
• Support Manufacturing and MSAT as process Subject Matter Expert, including on floor support.
• Author high-quality documents such as experimental protocols, technical reports, risk/gap assessments, SOPs, and facility fit assessments.
• Process and Subject Matter Expert review on batch records.
• Lead, train, and mentor junior lab staff.
• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding.
• Contribute to the overall operations of process sciences lab and infrastructure improvements.
• Serve as Process Science representative and participate in cross functional meetings.

Qualifications

• A university degree and 5-8+ years of related experience, or a Master’s degree and 3-5+ years, or a PhD and 1-3+ years of experience.
• Expertise in chromatographic processes, filtration techniques, protein chemistry, and associated analytical methods.
• Experience in scale-up/scale-down principles as well as the use of statistical tools for data analysis and DoE.
• Experience in process characterization, qualification/validation (PPQ) and/or continued process verification (CPV).
• Experience in viral clearance validation and scale down validation.
• Advanced proficiency with required software — Unicorn, JMP/MODDE, Word, Excel, PowerPoint.
• Demonstrate critical thinking, be self-motivated, accountable, inquisitive, have excellent organization and communication skills, and demonstrate the ability to work both independently and as a member of local and global teams.
• Excellent customer service skills and ability to meet client project deadlines.
• Flexibility of hours to support process development or MFG floor activities over weekends and holidays; weekend and holiday hours are compensated per company policies.
• Flexibility to switch between projects.

Working Conditions

• Laboratory and manufacturing clean-room environments working with chemical reagents and processing equipment.
• Compliance with Personal Protective Equipment, clean room gowning, and EH&S requirements.
• Normal office working conditions: computer, phone, files, printer, etc.
• Interaction with people in the lab, other departments, and clients.
• Fast-paced environment with job completion deadlines.

Physical Requirements

• Frequent lifting up to 10 lbs.
• Sitting for extended periods for computer-based work.
• Standing/walking to work in lab environment for extended periods.