Head of Process Analytics Development
Takeda
June 25, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Operations
Objectives/Purpose
- Lead Process Analytics Development team to develop high-throughput methods using traditional technologies, automation, PAT, and robotics.
- Oversee QbD-based IPM method development with scientific rigor and phase-appropriate bridging to GMP release/stability methods.
- Identify/prioritize high-value opportunities and deliver automation & PAT programs to improve productivity, throughput, data integrity, and laboratory execution consistency.
- Modernize end-to-end lab operations (sample/data management, instrument connectivity, workflow standardization). Provide multi-site leadership, governance/standards, and vendor oversight; ensure delivery, resourcing, and stakeholder alignment.
Accountabilities
- Establish non-GMP high-throughput IPM methods to support DPDD/SMPD/BPD; design/optimize methods using phase-appropriate QbD.
- Transfer and implement methods into process development groups; maintain non-GMP platforms across cross-functional teams.
- Develop automated analytical methods and end-to-end robotic workflows for GMP/non-GMP; create automation roadmaps aligned to regulatory standards.
- Create PAT methods/models for small molecules/biologics (GMP/non-GMP); enable monitoring/control of manufacturing processes.
- Lead strategy/roadmaps and cross-collaboration across analytical development, automation, and PAT.
Qualifications
- Hands-on familiarity with automation platforms (e.g., Hamilton, Agilent, Tecan, Opentrons).
- 10–12+ years industrial/lab experience with strong cross-functional project management.
- PhD in relevant science (or automation/robotics/engineering with analytical method development experience).
- Proven PAT expertise (real-time/at-line/in-line; multivariate/chemometrics; control strategy enablement).
- Track record scaling automation and deploying robotics-enabled high-throughput workflows; method transfer/validation/robustness.
- Excellent communication; strategic thinking; team leadership (20 people).
- Fluent English (Japanese plus).
Preferred
- Regulated-environment experience; AI-assisted knowledge work within compliance constraints.
Benefits (explicitly stated)
- Eligible for medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires.
- Lead Process Analytics Development team to develop high-throughput methods using traditional technologies, automation, PAT, and robotics.
- Oversee QbD-based IPM method development with scientific rigor and phase-appropriate bridging to GMP release/stability methods.
- Identify/prioritize high-value opportunities and deliver automation & PAT programs to improve productivity, throughput, data integrity, and laboratory execution consistency.
- Modernize end-to-end lab operations (sample/data management, instrument connectivity, workflow standardization). Provide multi-site leadership, governance/standards, and vendor oversight; ensure delivery, resourcing, and stakeholder alignment.
Accountabilities
- Establish non-GMP high-throughput IPM methods to support DPDD/SMPD/BPD; design/optimize methods using phase-appropriate QbD.
- Transfer and implement methods into process development groups; maintain non-GMP platforms across cross-functional teams.
- Develop automated analytical methods and end-to-end robotic workflows for GMP/non-GMP; create automation roadmaps aligned to regulatory standards.
- Create PAT methods/models for small molecules/biologics (GMP/non-GMP); enable monitoring/control of manufacturing processes.
- Lead strategy/roadmaps and cross-collaboration across analytical development, automation, and PAT.
Qualifications
- Hands-on familiarity with automation platforms (e.g., Hamilton, Agilent, Tecan, Opentrons).
- 10–12+ years industrial/lab experience with strong cross-functional project management.
- PhD in relevant science (or automation/robotics/engineering with analytical method development experience).
- Proven PAT expertise (real-time/at-line/in-line; multivariate/chemometrics; control strategy enablement).
- Track record scaling automation and deploying robotics-enabled high-throughput workflows; method transfer/validation/robustness.
- Excellent communication; strategic thinking; team leadership (20 people).
- Fluent English (Japanese plus).
Preferred
- Regulated-environment experience; AI-assisted knowledge work within compliance constraints.
Benefits (explicitly stated)
- Eligible for medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires.