Senior MSAT Downstream Process Engineer

Senior MSAT Downstream Process Engineer

About ScaleUp Bio

ScaleUp Bio is a Singapore-based fermentation CDMO supporting companies in scaling innovative food, nutrition and biotechnology products from pilot to commercial production. We operate pilot- and industrial-scale fermentation facilities and work closely with customers from process transfer through scale-up, validation and manufacturing.

Position Overview

We are seeking an experienced Senior MSAT Downstream Process Engineer to lead the transfer, scale-up, optimisation and technical execution of downstream processing operations.

The successful candidate will bring deep, hands-on experience in fermentation-based biotechnology, with strong expertise across clarification, separation, purification, concentration and drying operations. This role will serve as a senior technical authority for downstream processing and will work closely with Process Engineering, Production, Quality, Supply Chain and customer technical teams.

The position is suited to an experienced engineer who can combine strong scientific fundamentals with practical manufacturing judgement and disciplined execution in GMP or similarly controlled production environments.

Key Responsibilities

Process Transfer and Scale-Up

• Lead the technical transfer of customer downstream processes into ScaleUp Bio’s pilot and commercial manufacturing facilities.

• Assess customer process packages, identify technical gaps and translate laboratory-scale protocols into executable manufacturing processes.

• Develop and refine process flow diagrams, mass balances, operating parameters, equipment requirements and scale-up strategies.

• Evaluate process scalability, facility fit, equipment capability and operational risks before manufacturing.

• Design and execute engineering, verification, demonstration and manufacturing runs.

• Support downstream process scale-up across pilot and industrial production volumes.

Downstream Processing

Provide technical leadership and hands-on support for downstream unit operations, including:

• Disc-stack, tubular-bowl and other industrial centrifugation systems.

• Microfiltration and cell-removal operations.

• Ultrafiltration and diafiltration for concentration, buffer exchange and impurity reduction.

• Depth filtration and other clarification technologies.

• Hydrophobic interaction chromatography.

• Ion-exchange chromatography.

• Affinity chromatography.

• Chromatography resin selection, column packing, cleaning, sanitisation and lifecycle management.

• Protein, enzyme, peptide, microbial biomass and fermentation-derived product recovery.

• Spray drying and freeze drying.

• Process intermediate handling, hold-time management and bulk product storage.

• Cleaning, sterilisation and contamination-control procedures.

Process Optimisation and Troubleshooting

• Diagnose process failures, yield losses, filtration limitations, chromatography performance issues and drying-related product degradation.

• Lead structured root-cause investigations and implement effective corrective and preventive actions.

• Improve product recovery, purity, concentration, activity, consistency and overall process economics.

• Establish mass-balance expectations and ensure that material losses are properly investigated and documented.

• Identify opportunities to reduce processing time, consumable usage, waste generation and cost of goods.

• Apply sound process engineering principles and data analysis to establish robust operating ranges and critical process parameters.

• Provide technical guidance during deviations, out-of-specification results and non-conforming manufacturing runs.

Manufacturing and GMP Operations

• Provide floor-level technical support during process execution, including critical or high-risk downstream operations.

• Ensure processes are designed and executed in accordance with applicable GMP, food-safety, biosafety and quality requirements.

• Apply strong sterile and aseptic handling practices where required.

• Support cleaning validation, sterilisation strategies, equipment qualification and process validation activities.

• Review and approve batch manufacturing records, standard operating procedures, work instructions, protocols and technical reports.

• Ensure process documentation is complete, accurate, traceable and suitable for customer and regulatory review.

• Participate in internal, customer and regulatory audits as a downstream-processing subject-matter expert.

Customer and Cross-Functional Leadership

• Engage directly with customer technical teams to understand process requirements, communicate risks and agree on practical manufacturing strategies.

• Translate complex technical findings into clear recommendations for customers and senior management.

• Work closely with upstream fermentation engineers to optimise the interface between fermentation, harvest and downstream recovery.

• Collaborate with Production, Quality, Supply Chain, Facilities and Commercial teams to ensure projects are technically feasible and operationally deliverable.

• Support equipment selection, vendor evaluation, capital expenditure assessments and facility capability development.

• Mentor junior and mid-level engineers and strengthen downstream technical capabilities across the organisation.

• Contribute to project scoping, technical proposals, resource estimates and manufacturing timelines.

Candidate Requirements

Essential

• Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Bioprocess Engineering, Pharmaceutical Engineering or a related discipline.

• Typically 10–20 years of relevant industrial experience in downstream process development, MSAT, process engineering, technology transfer or biomanufacturing.

• Substantial experience within the pharmaceutical, enzyme, industrial fermentation, biopharmaceutical or related biotechnology industries.

• Strong hands-on knowledge of fermentation-derived product recovery and purification.

• Demonstrated experience with several of the following operations:

  • Centrifugation.

  • Microfiltration.

  • Ultrafiltration and diafiltration.

  • Depth filtration.

  • Hydrophobic interaction chromatography.

  • Ion-exchange chromatography.

  • Affinity chromatography.

  • Spray drying.

  • Freeze drying.

• Experience scaling downstream processes from laboratory or pilot scale into commercial manufacturing.

• Strong understanding of GMP environments, sterile handling, contamination control, cleaning and controlled manufacturing practices.

• Proven ability to troubleshoot technically complex process failures and improve product yield and consistency.

• Experience preparing or reviewing batch records, SOPs, risk assessments, deviation investigations and technical reports.

• Ability to work effectively with customers, equipment vendors and multidisciplinary internal teams.

• Strong written and verbal communication skills.

Advantageous

• Experience in upstream microbial fermentation using bacteria, yeast or fungi.

• Experience with recombinant proteins, enzymes, peptides, probiotics, specialty lipids or other fermentation-derived products.

• Familiarity with process validation, equipment qualification, cleaning validation and continued process verification.

• Knowledge of HACCP, FSSC 22000, FDA, FSMA or comparable regulated manufacturing frameworks.

• Experience selecting and commissioning downstream-processing equipment.

• Familiarity with design of experiments, statistical process analysis and process-modelling tools.

• Experience working in a CDMO or other multiproduct manufacturing environment.

Personal Attributes

• Technically rigorous, practical and comfortable working directly on the manufacturing floor.

• Takes ownership of process outcomes and follows issues through to resolution.

• Able to challenge assumptions constructively and communicate technical risks clearly.

• Comfortable operating in a fast-moving environment with multiple customer projects.

• Strong commitment to data integrity, product quality and operational discipline.

• Collaborative leader who develops others while remaining willing to work hands-on.

• Commercially aware and able to balance process robustness, customer requirements, timelines and manufacturing cost.