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Downstream Manufacturing (Classical Fermentation)
DGM / AGM
Open
+
Key Responsibilities
- Job Description:
- DGM / AGM – Downstream Manufacturing (Classical Fermentation)
- Reporting To
- Head –Biotech / Head- Down-Stream Process
- ________________________________________
- Job Summary
- The Employee will be responsible for leading downstream processing operations for classical fermentation-based biopharmaceutical products. The role involves overseeing separation, concentration, Column Chromatography, purification, and recovery activities while ensuring compliance with cGMP, quality standards, safety regulations, and production targets as per Pharmaceutical Industry norms. The position requires strong technical expertise in downstream bioprocessing and leadership capabilities to support commercial manufacturing operations efficiently and reliably.
- ________________________________________
- Key Responsibilities:
- Downstream Manufacturing Operations
- Lead and manage downstream processing activities for Fermentation and Bio-Transformation-derived biopharmaceutical products.
- Oversee operations including cell separation, filtration, centrifugation, extraction, concentration, chromatography drying, purification, and final product recovery.
- Ensure adherence to approved batch manufacturing records (BMR), SOPs, and production schedules.
- Monitor production performance to achieve yield, quality, and productivity targets.
- Coordinate manufacturing activities to ensure smooth integration with upstream fermentation and final packaging operations.
- Process Optimization & Technical Support
- Identify and implement process improvements to enhance recovery efficiency, product purity, and operational productivity.
- Troubleshoot downstream processing deviations, equipment issues, and process inefficiencies.
- Support scale-up, process transfer, and commercialization of new products.
- Participate in technology transfer activities from R&D to manufacturing.
- Compliance & Quality Assurance
- Ensure compliance with cGMP, regulatory guidelines, biosafety standards, and data integrity requirements.
- Review and approve production documentation, logbooks, and batch records.
- Lead investigations related to deviations, OOS/OOT events, CAPA, and change controls.
- Support regulatory inspections, customer audits, and internal quality audits.
- Equipment & Validation
- Oversee operation and maintenance coordination for downstream equipment such as:
- Centrifuges
- Chromatography systems
- Filtration units
- Evaporators
- Spray dryers / freeze dryers
- Support qualification and validation activities including IQ/OQ/PQ, cleaning validation, and process validation.
- Team Leadership
- Manage and mentor production supervisors, engineers, operators, and technical staff.
- Ensure proper manpower planning, training, and competency development.
- Promote a culture of operational excellence, teamwork, and compliance.
- Safety & EHS
- Ensure safe handling of biological materials, chemicals, solvents, and process intermediates.
- Maintain compliance with environmental, health, and safety (EHS) requirements.
- Drive implementation of safe work practices and risk mitigation initiatives.
- ________________________________________
- Required Qualifications:
- Bachelor’s or Master’s degree in:
- Biochemical Engineering
- Chemical Engineering
- ________________________________________
- Experience:
- 10–15+ years of experience in downstream manufacturing within biopharmaceutical, fermentation, or biotechnology focussed industries.
- Strong expertise in downstream processing and purification technologies.
- Experience in GMP-regulated manufacturing facilities.
- Proven experience in handling commercial-scale operations and technical teams.
- ________________________________________
- Technical Skills:
- Strong understanding of downstream bioprocessing principles and unit operations.
- Experience with purification technologies such as filtration, chromatography, precipitation, and drying systems.
- Familiarity with process automation systems, CIP/SIP operations, and manufacturing control systems.
- Knowledge of cGMP, FDA, EMA, WHO, and other regulatory standards.
- Proficiency in batch documentation, validation protocols, and deviation investigations.
- ________________________________________
- Behavioral Competencies:
- Strong leadership and people management skills
- Analytical and problem-solving capabilities
- Effective communication and cross-functional collaboration
- Attention to detail and quality focus
- Ability to manage multiple priorities under tight timelines
- ________________________________________
- Preferred:
- Experience in manufacturing of antibiotics, enzymes, probiotics, or biologics.
- Exposure to SAP, MES, SCADA, or automation platforms.
- Lean Manufacturing / Six Sigma certification preferred.
- ________________________________________
→
Downstream Manufacturing & R&D
Vice President / AVP / Sr. GM
Open
+
Key Responsibilities
- Job Description
- Vice President / AVP / Sr. GM – Downstream Manufacturing & R&D
- Reporting To
- Chief Executive Officer (CEO) / Managing Director / Chief Operating Officer (COO)
- ______________________________________
- Position Summary
- The Vice President – Biopharma Downstream Manufacturing & R&D is a senior executive leadership role responsible for leading enterprise-wide downstream bioprocessing operations, commercial manufacturing, process development, and innovation strategy for the organization.
- The role demands a highly accomplished biopharma professional with extensive expertise in
- - Classical Fermentation downstream and purification technologies,
- - Enzymatic / Bio-transformation downstream and purification technologies,
- - Down-Stream process development, scale-up, and manufacturing at plant scale under cGMP operations.
- - Biologics Drug Substance downstream and purification technologies (preferred but not mandatory)
- - technology transfer, and scientific leadership. The incumbent will lead integrated Manufacturing and R&D functions with full accountability for operational excellence, process innovation, regulatory compliance, commercialization readiness, and organizational growth.
- The successful candidate should possess deep experience in particular in Down-Stream science applicable in related to Biotechnology including Classical Fermentation, Bio-Transformation, enzymatic processes, and preferred with understanding of Biologics, recombinant proteins, monoclonal antibodies MABs, biosimilars related Down-stream processes.
- ________________________________________
- Key Executive Responsibilities
- Strategic Leadership
- • Provide strategic direction for biopharma downstream manufacturing and process development operations.
- • Lead long-term organizational growth initiatives related to biologics manufacturing, purification technologies, and innovation platforms.
- • Develop and implement enterprise-wide manufacturing and R&D strategies aligned with business objectives.
- • Drive operational transformation through process optimization, automation, digitalization, and continuous improvement initiatives.
- • Serve as a key member of the executive leadership team contributing to corporate strategy, investment planning, and business expansion.
- ________________________________________
- Manufacturing Leadership
- Commercial Biopharma Manufacturing Oversight
- • Lead all downstream development, scale up and manufacturing operations for commercial biopharmaceutical products.
- • Ensure robust manufacturing execution for downstream & purification processes.
- • Oversee manufacturing scheduling, production planning, process engineering, validation, and operational readiness.
- • Drive improvements in:
- o Manufacturing productivity
- o Batch success rates
- o Capacity utilization
- o Cost efficiency
- o Yield enhancement
- o Product consistency
- • Ensure uninterrupted commercial supply through strong operational governance and risk management.
- • Lead facility expansion and process capacity enhancement initiatives.
- ________________________________________
- Technical Expertise & Process Ownership
- Provide enterprise-wide technical leadership in downstream bioprocessing operations including:
- Core Technologies
- • Clarification systems
- • Centrifugation
- • Depth filtration
- • Tangential flow filtration (TFF)
- • Ultrafiltration and diafiltration (UF/DF)
- • Chromatography systems
- • Affinity purification
- • Ion exchange chromatography
- • Hydrophobic interaction chromatography
- • Viral clearance systems
- • Endotoxin clearance systems
- • Protein concentration and polishing
- • Lyophilization, Spray Drying and other drying related technologies
- Functional Responsibilities
- • Lead process optimization and downstream yield improvement initiatives.
- • Develop scalable and commercially viable purification platforms.
- • Improve product recovery, impurity clearance, and process robustness.
- • Troubleshoot complex purification and process consistency issues.
- • Drive implementation of advanced downstream technologies and automation systems.
- • Ensure process reproducibility and lifecycle management.
- ________________________________________
- Research & Development Leadership
- Process Development & Innovation
- • Lead R&D programs focused on:
- o Process intensification
- o Novel purification technologies
- o Process analytical technologies (PAT)
- o Single-use technologies
- o Continuous bioprocessing
- o Manufacturing digitization
- • Drive scale-up activities from laboratory to pilot and commercial manufacturing.
- • Oversee technology transfer programs between R&D and manufacturing sites.
- • Lead scientific innovation initiatives to improve productivity, quality, and cost competitiveness.
- • Build strong intellectual property and process innovation portfolios.
- • Collaborate with global scientific, academic, and technology partners.
- ________________________________________
- GMP, Quality & Regulatory Compliance
- Compliance Leadership
- • Ensure compliance with:
- o cGMP
- o US FDA
- o EMA
- o MHRA
- o WHO
- o ICH guidelines
- o Data integrity requirements
- • Lead inspection readiness and regulatory audit management.
- • Partner with Quality Assurance and Regulatory Affairs to ensure manufacturing and development compliance.
- • Oversee process validation, cleaning validation, and qualification activities.
- • Ensure implementation of robust quality systems and risk management practices.
- ________________________________________
- Technology Transfer & Commercialization
- Scale-Up & Commercial Launch Leadership
- • Lead end-to-end technology transfer for new products and manufacturing platforms.
- • Support commercialization of biologics and biosimilars products.
- • Ensure successful process characterization and validation for commercial launch.
- • Coordinate cross-functional readiness for product approvals and global market supply.
- • Support regulatory submissions through technical documentation and process data.
- ________________________________________
- Required Qualifications
- Educational Qualifications
- • Ph.D., M.Tech, M.Pharm, or Master’s degree in:
- o Biochemical Engineering
- o Chemical Engineering
- o Pharmaceutical Sciences
- o Bioprocess Engineering
- o Life Sciences
- ________________________________________
- Experience Requirements
- • 20+ years of progressive experience in biopharmaceutical manufacturing and downstream process development.
- • Significant leadership experience in biologics or biosimilars manufacturing environments.
- • Deep expertise in downstream purification and commercial bioprocess operations.
- • Proven track record of leading integrated Manufacturing and R&D organizations.
- • Extensive experience in technology transfer, process validation, and commercialization.
- • Strong exposure to global regulatory inspections and cGMP systems.
- ________________________________________
- Preferred Industry Experience
- • Monoclonal antibodies
- • Recombinant proteins
- • Biosimilars
- • Plasma-derived products
- • Fermentation-derived biologics
- • Cell culture manufacturing
- • Contract development and manufacturing (CDMO)
- ________________________________________
- Core Technical Competencies
- • Downstream Bioprocessing
- • Purification Technologies
- • Process Scale-Up
- • Technology Transfer
- • Process Validation
- • GMP Operations
- • Continuous Manufacturing
- • Single-Use Systems
- • Process Automation
- • Lean Manufacturing
- • PAT & Digital Manufacturing
- • Risk Management
- • Regulatory Compliance
- ________________________________________
- Leadership Competencies
- • Executive Leadership
- • Strategic Planning
- • Innovation Management
- • Change Leadership
- • Cross-Functional Collaboration
- • Stakeholder Management
- • Organizational Development
- • Financial Acumen
- • Problem Solving & Decision Making
- • Global Team Leadership
- Compliance Metrics
- • Audit readiness
- • Regulatory inspection outcomes
- • CAPA effectiveness
- • Deviation reduction
- • Data integrity compliance
- Business Metrics
- • EBITDA contribution
- • Operational efficiency gains
- • Budget adherence
- • Customer supply reliability
- • Business growth support
- ________________________________________
- Ideal Candidate Profile
- The ideal candidate is:
- • A highly respected biopharma downstream processing leader with strong scientific and operational expertise.
- • Experienced in managing large-scale manufacturing and R&D organizations within regulated pharmaceutical environments.
- • Capable of driving innovation while maintaining commercial manufacturing discipline.
- • Skilled in building world-class Fermentation based manufacturing capabilities.
- • Adept at leading complex cross-functional teams and strategic business initiatives.
- • Passionate about operational excellence, scientific advancement, and organizational growth.