DGM (Head) Process Development Biologics

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd in Telangana, Hyderabad is seeking a Head of Process Development with extensive experience in vaccines and biologics process development. The role focuses on leading a team of scientists and engineers to drive early-stage development through GMP transfer and manufacturing support for human clinical trials.

You will oversee upstream and downstream operations, formulation and analytical method development, and collaborate with cross-functional teams and senior

Qualifications

• Postgraduate or PhD degree in a relevant Science or Engineering field.
• Experience: 16+ years in mABs, gene therapy, recombinant vaccines and/or biologics process development.
• Practical experience with vaccines and biologics processes/unit operations, including adherent/suspension cell culture, harvest, downstream process (Chromatography, TFF), formulation and analytical methods.

Responsibilities

• Lead the Process Development department comprising scientists and engineers for vaccine/biologics development from early-stage development to GMP manufacturing.
• Oversee upstream (fermentation, cell culture, virus production) and downstream (harvest, purification) activities, including formulation and analytics.
• Drive Technology Transfer and scale-up to support GMP manufacturing and clinical trials.
• Engage with cross functional teams, senior management, external partners and stakeholders.

Skills

People leadership

Project planning

Cross-functional collaboration

Interpersonal skills

Presentation skills

Education

PhD or PG in science/engineering

Job description

Responsibilities

• This position requires demonstrated ability to work effectively as both scientific/technical and people leader, manage tasks, resolve problems and issues and drive implementation/action plans to meet objectives along with excellent interpersonal and presentation skills.
• The candidate should be self- sufficient in planning and execution along with applying innovative thinking to improve effectiveness and efficiency of the function. A person in this role is expected to engage and interact frequently with cross functional teams, senior management, external partners/collaborators, and stakeholders.
• The incumbent will be responsible for leading the Process Development department comprising of scientists and engineers responsible for developing the clinical/commercial process(es) for novel vaccines and biologics products from early-stage process development & optimization, and scale-up to supporting Technology Transfer and GMP manufacturing activities for human clinical trials.
• The Head Process Development will be responsible for upstream (fermentation, cell culture, virus production etc.) and downstream (harvest & purification) activities along with formulation and analytical method development.
• This position requires demonstrated ability to work effectively as both scientific/technical and people leader, manage tasks, resolve problems and issues and drive implementation/action plans to meet objectives along with excellent interpersonal and presentation skills.
• The candidate should be self- sufficient in planning and execution along with applying innovative thinking to improve effectiveness and efficiency of the function. A person in this role is expected to engage and interact frequently with cross functional teams, senior management, external partners/collaborators, and stakeholders.

Qualification & Expeirence

• Postgraduate or PhD degree in a relevant Science or Engineering field
• Experience: 16 plus years of relevant industry experience in mABs, gene therapy , recombinant vaccines and/or biologics process development
• Practical experience with vaccines and biologics processes/unit operations, including adherent and suspension cell culture, harvest, downstream process (Chromatography, TFF etc), formulation and analytical methods etc.