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Key Responsibilities and Required Skills for Biochemical Engineer

💰 $ - $

EngineeringBiotechnologyPharmaceuticals

🎯 Role Definition

A Biochemical Engineer designs, develops, and optimizes biologically based processes and systems for the production of biologics, enzymes, biofuels, and other bioproducts. This role integrates bioprocess development (cell culture, fermentation), downstream purification, analytical testing, process scale-up and technology transfer to manufacturing while ensuring quality, regulatory compliance (cGMP/GLP), safety, and cost-effectiveness. The Biochemical Engineer partners with cross-functional teams (R&D, Manufacturing, Quality, Regulatory and Supply Chain) to deliver robust, scalable processes that meet performance, yield and regulatory targets.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Bioprocess Technician / Biomanufacturing Technician
  • Process Development Associate / Research Associate (Biology/Chemical)
  • Chemical/Biological Engineering New Graduate

Advancement To:

  • Senior Biochemical Engineer / Lead Process Engineer
  • Process Development Manager / Principal Scientist – Bioprocess
  • Manufacturing/Operations Manager (Biologics)

Lateral Moves:

  • Quality (GMP) Engineer or QA Specialist
  • Regulatory Affairs Scientist
  • Analytical Development Scientist

Core Responsibilities

Primary Functions

  • Lead the design, execution and interpretation of bench-scale and pilot-scale bioprocess development experiments (cell culture, microbial fermentation, enzyme reactions) to optimize yield, titer, productivity and product quality according to project objectives.
  • Develop and optimize upstream processes including seed trains, inoculation strategies, media formulation, feeding regimes (fed-batch, perfusion), and bioreactor control strategies to maximize cell growth and product expression.
  • Design, evaluate and refine downstream purification workflows (clarification, chromatography, filtration, concentration) to achieve target purity, recovery and impurity profiles while minimizing cost and cycle time.
  • Plan and execute process scale-up from lab scale to pilot and commercial scale, including preparation of scale-up strategies, similarity criteria, mass balances, and dimensionless scaling rules for mixing, oxygen transfer and residence time.
  • Prepare and execute Design of Experiments (DOE) and statistical process optimization studies to identify critical process parameters (CPPs) and establish design space and operation limits.
  • Implement and monitor Process Analytical Technology (PAT) and online/offline analytical methods to enable real-time process monitoring, control and continuous improvement.
  • Generate robust process characterization data to support process validation, regulatory submissions, and risk assessments; create validation protocols and reports in accordance with cGMP.
  • Lead technology transfer activities to pilot or commercial manufacturing sites including preparation of tech transfer packages, batch records, process flow diagrams, equipment specifications and training of manufacturing personnel.
  • Troubleshoot process deviations, equipment issues and product quality trends in manufacturing; lead root cause investigations, corrective and preventive actions (CAPA), and implement process improvements.
  • Collaborate closely with Quality Assurance and Regulatory teams to ensure process development activities meet regulatory expectations (FDA, EMA) and internal quality systems.
  • Author and maintain technical documentation including SOPs, batch records, validation documents, experimental plans, technical reports, and regulatory submission materials with attention to cGMP documentation requirements.
  • Lead vendor selection, qualification and management for critical equipment, consumables and services; evaluate vendor performance, drive procurement specifications and support site commissioning.
  • Design and support installation and commissioning of bioprocess equipment (bioreactors, fermenters, chromatography skids, filtration systems), specifying scale, materials of construction, control requirements, and utilities.
  • Perform mass and energy balances, process modeling and simulation to predict performance, optimize utilities consumption and support capital and operating cost estimates.
  • Apply aseptic technique and sterile processing best practices to maintain product integrity in upstream and downstream operations and reduce contamination risk.
  • Coordinate cross-functional project teams, deliver project plans, timelines and status updates; manage project budgets, milestones and resource allocation in line with product development goals.
  • Apply analytical techniques (HPLC, GC, LC–MS, SDS-PAGE, ELISA, UV/Vis, qPCR) to characterize product quality attributes, impurities and raw material impacts on process performance.
  • Drive continuous improvement initiatives (yield increases, cost reduction, cycle time reduction) using Lean, Six Sigma and root cause methodologies to improve process robustness and operational efficiency.
  • Mentor and coach junior engineers and scientists, review experimental designs and data, and build team capabilities in bioprocess engineering principles.
  • Support clinical and commercial manufacturing campaigns with process support during scale-up, tech transfer, and early product launches to ensure successful ramp-up and product release.
  • Ensure laboratory and pilot facilities comply with safety, environmental and biosafety regulations; lead risk assessments and implement containment and hazard controls.
  • Evaluate and propose new technologies (single-use systems, continuous processing, automation, new chromatography resins) to modernize processes and reduce risk and cost.
  • Contribute to intellectual property generation by documenting novel process innovations and supporting patent filings or invention disclosures.
  • Communicate technical progress and results to senior leadership and external stakeholders through written reports and oral presentations.

Secondary Functions

  • Participate in cross-functional troubleshooting calls and support manufacturing investigations during deviations and product complaints.
  • Support internal audits, supplier audits and regulatory inspections by preparing documentation, responding to findings and implementing corrective actions.
  • Assist in procurement planning by estimating consumable needs for process development experiments and pilot campaigns.
  • Contribute to departmental hiring, onboarding and training programs for technical staff and contractors.
  • Stay current with scientific literature, industry trends and competitor technologies to inform process improvements and strategic decisions.
  • Help maintain laboratory inventory, calibration schedules and equipment preventative maintenance logs.
  • Support sustainability initiatives by evaluating waste streams, water/energy usage and recommending greener process options.
  • Provide subject-matter expertise for cross-disciplinary initiatives (automation, data analytics, digital twin development) to enhance process understanding.

Required Skills & Competencies

Hard Skills (Technical)

  • Bioprocess development expertise: upstream cell culture (mammalian, yeast, bacterial) and microbial fermentation process development.
  • Downstream purification skills: design and optimization of chromatography, filtration (TFF), centrifugation and viral clearance processes.
  • Hands-on experience with bioreactors, fermenters and single-use systems, including scale-up criteria and control strategies.
  • Proficiency with analytical techniques: HPLC, GC, LC–MS, SDS-PAGE, ELISA, UV/Vis spectroscopy, qPCR and endotoxin testing.
  • Strong experimental design skills including Design of Experiments (DOE), multivariate analysis and statistical software (e.g., JMP, Design-Expert).
  • Knowledge of regulatory requirements and quality systems: cGMP, GLP, FDA/EMA expectations, process validation and documentation.
  • Process modeling and mass balance calculations; familiarity with simulation tools and MATLAB or Python for data analysis.
  • Experience with Process Analytical Technology (PAT), process control strategies and automation platforms (PLC, SCADA, distributed control systems).
  • Tech transfer and scale-up experience with creation of robust tech transfer packages, batch records and operator training materials.
  • Experience with process characterization, robustness studies and establishing control strategy and critical quality attributes (CQAs).
  • Familiarity with upstream media formulation, fermentation kinetics, oxygen transfer (kLa), mixing and heat transfer considerations.
  • Knowledge of sterilization methods, aseptic processing and contamination control practices.
  • Track record of applying Lean/Six Sigma and continuous improvement methodologies to increase yield and reduce costs.
  • Capacity to manage vendors, equipment specification and qualification (IQ/OQ/PQ).

Soft Skills

  • Strong written and verbal communication skills to draft reports, SOPs, regulatory documents and present technical results to stakeholders.
  • Cross-functional collaboration and interpersonal skills to work with R&D, QA, Regulatory, Manufacturing and Supply Chain teams.
  • Analytical problem-solving with a data-driven mindset and attention to detail for troubleshooting complex process issues.
  • Project management skills: planning, prioritization, timeline management, and budget awareness.
  • Leadership and mentoring to develop junior staff and lead small project teams.
  • Adaptability and resilience to manage fast-paced development timelines and ambiguity.
  • Time management and organization to coordinate multiple experimental campaigns and deliverables.
  • Critical thinking and scientific judgement to evaluate data, make decisions and escalate appropriately.
  • Strong ethical standards and commitment to safety, compliance and product quality.
  • Customer- and outcome-focused approach to meet milestones for clinical and commercial supply.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Bioengineering, Biotechnology, Molecular Biology or related field.

Preferred Education:

  • Master’s or PhD in Biochemical Engineering, Bioprocess Engineering, Chemical Engineering, Biotechnology or related discipline preferred for senior roles.

Relevant Fields of Study:

  • Biochemical Engineering / Bioprocess Engineering
  • Chemical Engineering
  • Bioengineering / Biotechnology
  • Molecular Biology / Microbiology / Biochemistry

Experience Requirements

Typical Experience Range:

  • 2–8+ years in bioprocess development, process engineering or related roles depending on seniority (entry-level: 0–3 years; mid-level: 3–6 years; senior: 6+ years).

Preferred:

  • Demonstrated hands-on experience in upstream and downstream process development, scale-up and tech transfer in biotech, biopharma, industrial biotech or academic translational projects.
  • Prior experience working under cGMP or in a regulated manufacturing environment, and involvement in process validation or regulatory submissions is highly desirable.
  • Certifications such as Six Sigma, GMP/GLP training, or project management (PMP) are advantageous.
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