M1
jfo_jfm_process-analytical-development-downstream-process-developmen::M1
Downstream Process Development Supervisor

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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Track

Management

Family rungs priced

11-0000

Coordinates

3 / 4 spaces

pay@2 · 2026-07

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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As of · 2026-07-30

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