Senior Engineer, MS&T

Technology-transfer focused role supporting downstream microbial biologics, document authoring/review, and 24/7 manufacturing-facility operations.

Responsibilities

• Provides process-engineering ownership for a product, including all process-transfer and implementation decisions.
• Serves as Subject-Matter Expert for all downstream drug-substance operations (chromatography, tangential-flow filtration, clarification, normal filtration, etc.).
• Reviews and approves significant technical documents: process descriptions, process-qualification protocols and reports, and CPV reports.
• Generates technical solutions to difficult problems through individual effort and external expertise.
• Delegates and manages the work product of others.
• Supports 24/7 plant operations via rotating on-call or on-floor activities.
• Works with minimal direction toward long-range goals; conceives and conducts engineering studies of considerable scope and complexity.
• Leads efforts within functional boundaries and influences adjacent organizations; may directly supervise project resources.
• Acts as primary technical contact with clients on projects.

Requirements

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related field.
• 11+ years of experience in bioprocess development or manufacturing within biotech/biopharma.
• Expertise in biologics, cell/gene therapy, and drug-substance production processes.
• Strong understanding of cGMP regulations, FDA/EMA guidelines, and validation principles.
• Demonstrated leadership in cross-functional teams and project management.
• Excellent communication, analytical, and problem-solving skills.
• Experience with regulatory submissions (IND, BLA, MAA) is a plus.

Pay

$118,000 – $178,000 per year, based on qualifications and experience.

Benefits

• Annual bonus structure for all employees.
• Medical, dental, and vision coverage.
• Paid PTO and holidays.
• Sabbatical program.
• 401K matching with 100 % vesting in 60 days.
• Employee recognition programs.