Downstream Process Head For Biopharmaceutical Product Development

Job Title: Downstream Process Head Biopharmaceutical Product Development

Location: Hyderabad

Reports To: Head of the biologics

Department: Downstream Process Development

Job Description:

We are looking for an experienced Downstream Process Head to lead protein-based therapy process development, including design, optimization, troubleshooting, scale-up, and tech transfer, while ensuring regulatory compliance. This role also includes leadership in lab setup, team management, and client interactions for process discussions.

Key Responsibilities:

Team Leadership & Resource Management:

Lead and develop a high-performing team, setting goals and enhancing skills.

Ensure the team has necessary resources, training, and support for success.

Provide feedback, conduct training, and foster continuous improvement.

Lab Setup & Equipment Management:

Oversee lab equipment selection, installation, and maintenance for downstream processes.

Ensure necessary infrastructure and compliance with GMP, GLP, and client standards.

Downstream Process Development & Optimization:

Develop and optimize scalable purification processes for biopharmaceuticals, ensuring regulatory compliance.

Design and execute purification protocols for large-scale manufacturing.

Troubleshoot and optimize downstream processing operations.

Implement Quality by Design (QbD) principles to ensure product quality, safety, and efficacy.

Scale-Up & Technology Transfer:

Collaborate on scaling up purification processes from lab to commercial scale.

Support technology transfer to manufacturing, ensuring smooth scale-up and reliability.

Identify and mitigate scale-up risks based on lab findings.

Analytical Data Review:

Support analytical testing to assess product quality (purity, yield, stability).

Analyze data and provide recommendations for process improvements and scale-up.

CDMO & Business Support:

Collaborate with business development to identify opportunities and support proposals.

Provide technical expertise for feasibility assessments and cost estimates.

Manage budgeting and resource allocation for downstream process development projects.

Documentation & Compliance:

Prepare and review technical documentation (batch records, SOPs, etc.).

Ensure compliance with GMP, GLP, and regulatory guidelines.

Support regulatory submissions with process development documentation.

Preclinical Data & Regulatory Support

Generate preclinical data for regulatory submissions. Assist with regulatory documentation and compliance.

Problem Solving & Innovation:

Foster innovation and problem-solving for process optimization and continuous improvement.

Implement new technologies to enhance scalability and product quality.

Solve complex technical challenges and make strategic decisions in downstream processing.

Cross-Functional Coordination:

Coordinate with cross functional departments for smooth project execution.

Bridge communication between technical teams and non-technical stakeholders.

Collaboration & Communication:

Work with internal and external teams to align purification processes with project goals.

Provide technical expertise in client meetings and updates.

Qualifications:

Education:

Masters or Ph.D. degree in Biochemistry, Biotechnology, or related field.

Experience:

15+ years in biopharmaceutical downstream process development, including 4+ years in a leadership role within a CRO or CDMO.

Preferred Qualifications:

Experience in managing outsourced projects or working in a contract development and manufacturing environment.

Familiarity with regulatory agencies expectations (FDA, EMA) for purification processes.