P4P4 — Senior Professional
Manufacturing Operations Manufacturing Technical Specialist (Downstream)
Provides deep technical expertise in the purification and refinement phase of production, ensuring complex downstream bioprocesses are optimized and run reliably.
What this level means
Seasoned professional; handles complex tasks, may lead small teams or projects
- Scope
- A system or set of related features
- Autonomy
- Self-directed; reviewed at critical decision points
- Complexity
- Complex, ambiguous problems; devises new approaches
- Impact
- Multi-team / function outcomes
- Decision rights
- Owns technical decisions for a system; influences adjacent design
- Leadership
- Technical lead for focused efforts; mentors several
- Typical experience
- 5–8 yrs
What you'd do
- Monitor and support daily downstream manufacturing activities.
- Serve as the subject matter expert for downstream unit operations.
- Proactively seek ways to improve downstream efficiency, yield, and robustness.
- Ensure all downstream manufacturing procedures are accurate and up-to-date.
- Work closely with Upstream Process teams and Quality Assurance.
- Train manufacturing associates and technicians on complex downstream procedures.
- Lead the scale-up of downstream steps from pilot scale to manufacturing scale.
- Optimize downstream processes for efficiency and yield.
- Train staff on downstream procedures.
- Collaborate with upstream and quality teams.
- Ensure compliance with manufacturing standards.
- Lead scale-up projects.
Skills, knowledge & tools
- Technical expertise in purification processes
- Process optimization
- Training and mentoring
- Cross-functional collaboration
- Quality assurance practices
- Scale-up techniques
- Data analysis
- Problem-solving
- Downstream bioprocessing
- Biopharmaceutical manufacturing
- Quality control standards
- Process optimization techniques
- Scale-up methodologies
- Regulatory compliance
- Bioprocess engineering
- Technical documentation
- Analytical problem-solving
- Attention to detail
- Communication
- Leadership & Mentoring
- Adaptability
- Ethical Judgment
What good looks like
- Bachelor’s or Master’s degree in Chemical Engineering, Biochemistry, Biotechnology or related field.
- 5–8+ years of experience in biopharmaceutical manufacturing or process development.
- Certifications like ASQ Certified Quality Engineer (CQE) or Six Sigma Green Belt preferred.
Common titles
Manufacturing Operations IVManufacturing Operations 4Senior Manufacturing OperationsSr. Manufacturing OperationsUpstream Processing IVUpstream Processing 4Senior Upstream ProcessingSr. Upstream ProcessingDownstream Processing IVDownstream Processing 4Senior Downstream ProcessingSr. Downstream ProcessingManufacturing Operations Manufacturing Technical Specialist (Downstream)Senior Individual Contributor
What it pays
Market-pay benchmarks for this family × level are being recalibrated across all survey sources and will return shortly.
O*NET / SOC: 13-0000 — Business & Financial Operations Occupations (inferred)