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Downstream Manufacturing & R&D;
Vice President / AVP / Sr. GM

Open

Department: Biopharma Downstream

Experience: 20+ years

Qualification: Ph.D., M.Tech, M.Pharm, or Master’s degree

Published: 08 Jun 2026

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)

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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Preferred Industry Experience

- Monoclonal antibodies
- Recombinant proteins
- Biosimilars
- Plasma-derived products
- Fermentation-derived biologics
- Cell culture manufacturing
- Contract development and manufacturing (CDMO)

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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

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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

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Ideal Candidate Profile

The ideal candidate is:

- A highly respected biopharma downstream processing leader with robust 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.

📌 Downstream Manufacturing & R&D (India)
🏢 SYMBIOTEC PHARMALAB
📍 India