Advanced Downstream Processing Technician
jfo_jfm_biopharmaceutical-manufacturing-operations-downstream-processing · S4 — S4 — Lead Support Specialist · Support
An experienced individual contributor who independently executes complex downstream purification operations and troubleshoots process deviations in biopharmaceutical manufacturing.
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Track
Support
Family rungs priced
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Coordinates
2 / 4 spaces
pay@2 · 2026-07
What this role is
An experienced individual contributor who independently executes complex downstream purification operations and troubleshoots process deviations in biopharmaceutical manufacturing. At the Lead Support Specialist (S4) level, the role owns team process and quality, cross-case patterns and process gaps, and drives team-level quality and efficiency. Mentors and coordinates the support team.
What this level does
- Adapt established downstream methods to unfamiliar situations — new product introductions, scale changes or first-in-suite equipment — determining the setup and operating approach where no exact procedure yet exists
- Author and revise Standard Operating Procedures, Master Batch Records and study protocols for downstream unit operations, and specify, commission and qualify new purification equipment
- Lead investigation of complex or recurring downstream deviations to root cause and drive the resulting CAPAs to closure across shifts
- Serve as working lead for a downstream suite — planning run readiness, resolving conflicts between competing runs and priorities, and informally guiding and training less experienced associates
- Oversee daily downstream operations in a CGMP biologics environment, ensuring right-first-time execution and compliance across the crew
- Knowledge applied
- Extensive knowledge of downstream procedures and their administration, enough to adapt methods for unprecedented situations and to author the governing SOPs/MBRs.
- Complexity & problem solving
- Understands implications of process changes; recommends new solutions and leads complex deviation investigations to root cause.
- Collaboration & interaction
- Acts as working lead of a suite; determines methods for new assignments and informally guides/trains associates.
- Typical experience
- 4–6 yrs; advanced downstream support experience.
Skills at this level
- Purification unit operations
- — Sets up, operates and cleans chromatography systems, tangential-flow/UF-DF skids and viral filtration equipment to produce and polish bulk biologic drug substance.
- Buffer and media preparation
- — Weighs, mixes and QC-checks buffer and media solutions to specified recipes and stages them for downstream production runs.
- Good Documentation Practice (GDP)
- — Records batch parameters and completes/reviews batch records contemporaneously and accurately so downstream work meets Right-First-Time and data-integrity requirements.
- Batch record execution
- — Follows Master Batch Records and study protocols step-by-step to run downstream operations in a CGMP-compliant sequence with correct hold points and in-process checks.
- Cleanroom and 5S discipline
- — Maintains cleanroom facilities and downstream equipment in a controlled, organized state using 5S practices to preserve product and environmental integrity.
- Downstream equipment maintenance and troubleshooting
- — Performs preventive maintenance and diagnoses in-process faults on chromatography, filtration and mixing equipment (column packing, TFF flux, filter integrity) to keep runs on track.
- Raw material inventory control
- — Monitors, orders, receives and distributes downstream raw materials and consumables so scheduled runs are supplied without stockouts or expiry issues.
- Deviation and CAPA authoring
- — Investigates downstream floor deviations, documents root cause and writes corrective and preventive actions to prevent recurrence.
- SOP and MBR authoring
- — Writes and revises Standard Operating Procedures and Master Batch Records for downstream unit operations, translating process intent into executable GMP instructions.
- Equipment commissioning and qualification
- — Specifies, commissions and executes qualification/requalification protocols for new and existing downstream purification equipment.
- Process transfer
- — Transfers downstream processes between process development, the manufacturing floor, CMOs and partner sites, converting development conditions into qualified production procedures.
- Working lead coordination
- — Plans run readiness, sequences equipment turnover and assigns tasks across a downstream suite or shift, guiding and training less experienced associates without formal supervisory authority.
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As of · 2026-07-30
Edition · canon-v2@2.1.0-complete
Source · canon-v2 cell + salary-benchmark (model)
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