Downstream Process Development Supervisor
jfo_jfm_process-analytical-development-downstream-process-developmen · M1 — M1 — Manager (Team Lead) · Management
First-line manager overseeing a small team of downstream process development scientists and associates.
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What this role is
First-line manager overseeing a small team of downstream process development scientists and associates. At the Manager (Team Lead) (M1) level, the role owns a single team, day-to-day delivery and people issues, and drives team output and health. Direct people management of one team.
What this level does
- Supervises a unit of scientists executing lab-scale chromatography, filtration, and UFDF experiments, assigning daily bench work and reviewing experimental data for accuracy
- Ensures accurate and timely documentation in electronic laboratory notebooks and technical reports across the team
- Coordinates with upstream/downstream process development and process analytical groups on sample hand-offs and experimental schedules
- Trains junior scientists on established purification methods, HPLC/UPLC characterization, and lab safety practices
- Manages equipment operations for chromatography systems and filtration technologies within the unit
- Knowledge applied
- Functional expert in downstream unit operations (chromatography, filtration, UFDF) with some leadership exposure; applies established purification practices to a defined unit's work.
- Complexity & problem solving
- Limited scope; resolves routine experimental and documentation issues using established methods and protocols.
- Collaboration & interaction
- Daily interactions with bench staff and peer groups in upstream, downstream, and process analytical development.
- Typical experience
- Functional expertise in downstream purification with initial supervisory responsibility over individual contributors.
Skills at this level
- Chromatography
- — Directs purification strategy using multiple chromatographic modes (SEC, RP, IEX, HILIC, affinity) to separate biological products and remove product- and process-related impurities.
- Filtration
- — Oversees downstream filtration unit operations — depth filtration, viral filtration, membrane filtration, and TFF — for clarification and concentration of biologic products.
- Ultrafiltration/Diafiltration (UFDF/TFF)
- — Guides membrane-based concentration and buffer-exchange operations to reach target formulation conditions for biologic products.
- Scale-down model development
- — Leads building and qualifying robust scale-down models used for process characterization and continued process improvement of commercial products.
- Statistical process design
- — Applies and champions statistical design and analysis of experiments to establish robust, well-characterized manufacturing process parameters.
- Technology transfer
- — Manages transfer of downstream processes from lab to GMP manufacturing, coordinating scale-up, batch records, and cross-functional stakeholder alignment.
- Protein characterization
- — Oversees analysis of purified proteins to assess purity, yield, and clearance of product variants and process-related impurities across development stages.
- Analytical method development/validation
- — Directs design, execution, and validation of characterization and release/stability methods per ICH Q2 (R2) guidance to support process decisions.
- Spectroscopy (PAT)
- — Guides deployment of Raman, FTIR, and NIR spectroscopy as Process Analytical Technology to measure and control downstream operations in real time.
- Chemometrics / multivariate modeling
- — Applies multivariate modeling and data-analysis approaches to interpret combined process and analytical data and inform control strategy.
- Data science / digital modeling
- — Leverages data science and advanced modeling to build digital platforms for biophysical, process, economic, and multivariate visualization and analysis.
- CMC regulatory authoring
- — Directs authoring and review of CMC sections of regulatory submissions (IND, BLA), ensuring downstream process data supports filing strategy.
- Process troubleshooting and investigations
- — Leads root-cause investigation and resolution of downstream process deviations during scale-up, validation, and commercial manufacturing support.
- Team leadership and technical mentoring
- — Builds and develops downstream scientists and engineers, coaching on purification science and driving alignment on technical strategy across matrixed teams.
- External partnership and thought leadership
- — Represents the organization as a downstream bioprocess expert through conferences, publications, patents, and collaborations with academia, industry, and vendors.
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https://jobframe.global/profile/jfo_jfm_process-analytical-development-downstream-process-developmen%3A%3AM1
As of · 2026-07-30
Edition · canon-v2@2.1.0-complete
Source · canon-v2 cell + salary-benchmark (model)
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