Manufacturing Associate/Process Development Scientist (Upstream/Bioreactor/Downstream)

$135,200 - $145,600/Yr

Systems Ally - Waltham, MA

Full-time - Mid Level

Waltham, MA

About the position

The Manufacturing Associate/Process Development Scientist role focuses on leading projects in manufacturing process areas to enhance efficiencies, improve quality, and reduce costs. The position involves technical support, data analysis, and project management within a biopharmaceutical manufacturing environment, specifically in upstream and downstream processes.

Responsibilities

• Lead projects in manufacturing process areas to achieve process efficiencies such as increase in process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
• Gather and analyze process data using statistical process control methodology.
• Develop action plan to increase process robustness, prevent product loss, and control quality impact.
• Participate in process performance monitoring such as Track & Trend.
• Provide technical support in the resolution of shop floor situations and execute assigned tasks as required by the operational area.
• Lead investigations by following a structured problem-solving approach and employing sound scientific principles when identifying root causes and developing recommendations related to product and process.
• Generate technical justification to support and/or document process deviations/investigations and determine impact on product quality, yield, and product registration.
• Be part of a cross-functional team responsible for implementation of site projects/initiatives that lead to process remediation.
• Manage smaller team projects within larger projects, including project coordination, monitoring, reporting, meeting management, and team communication.
• Lead the implementation of process validation for operational changes, new raw materials, and introduction of new processes/technology.
• Generate technical justification determining impact of change and protocols/reports/manufacturing documents that support its execution.
• Assist in the execution of experimental, demonstration, and validation lots.
• Maintain up-to-date product process documentation and assure compliance with applicable procedures and regulations.
• Write justification memos and scientific reports of quality controls and manufacturing documents.
• Provide scientific and technical support during regulatory audits and agency inspections.
• Demonstrate accountability and responsibility for EHS performance and compliance through active participation in EHS programs.

Requirements

• BS or MS in Chemistry, Biology, or Engineering (Chemical, Mechanical, Bio-chemical).
• Technical experience in Process/Manufacturing/Project Engineering or similar role.
• 5-7 years of experience in a similar role.
• Technical knowledge in fundamentals of biologics and/or antibody drug conjugation manufacturing.
• Effective verbal and written communication skills in English.

Nice-to-haves

• Experience in upstream process (5 years preferred).
• Experience in downstream process (3 years preferred).
• Experience in bioreactor (5 years preferred).
• Experience in mammalian cell culture (5 years preferred).
• Experience as a process development engineer (5 years preferred).

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance