Staff Engineer, Process Development

Responsibilities

• Develop, characterize, and optimize purification processes for biotherapeutics across microscale, bench, and pilot scales.
• Support both early-stage and late-stage development programs.
• Lead or support technology transfer activities into internal and external GMP manufacturing environments.
• Act as a Subject Matter Expert (SME) and primary point of contact for downstream operations.
• Support regulatory filings through technical documentation, data generation, and section authoring.
• Drive innovation by defining new process platforms and implementing process improvements.
• Collaborate with external partners and contract development/manufacturing organizations (CDMOs).
• Coach and mentor junior team members and lead small project teams.

Requirements

• Bachelor’s degree with 8+ years of experience, Master’s degree with 6+ years of experience, or PhD with relevant experience in chemistry, biology, pharmacy, or engineering.
• Proven experience in CMC development of biotherapeutics under cGMP standards.
• Deep technical expertise in chromatography, harvest operations, UF/DF, and viral clearance.
• Experience contributing to regulatory filings and working with external manufacturing partners.
• Strong analytical and problem-solving skills to troubleshoot complex process challenges.
• Excellent communication skills for technical documentation and cross-functional collaboration.

Benefits

• Competitive base salary range.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off and well-being benefits.
• Paid vacation and sick time.

About the Company

Takeda is an industry-leading, global pharmaceutical company dedicated to putting patients at the center of everything they do. Driven by the values of Integrity, Fairness, Honesty, and Perseverance, Takeda strives to deliver Better Health and a Brighter Future through leading innovation in medicine.