DGM Head Process Development Biologics

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

DGM Process Development Biologics

Job Description

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.

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.

Will report to Site Head Biologics

Qualification:

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.
• Experience with technology transfer and development of processes and technologies for robust scale-up and GMP manufacturing operations
• Experience of developing bioprocesses from early stages of development for novel molecules (vaccine antigens or biologics) is highly desirable
  
  

• Experience in authoring and compiling data for regulatory submissions (IND etc)
• Experience of establishing and/or enhancing development and commercial processes and systems compliant with Indian and international requirements.
• An excellent leader with experience of managing teams of high-performing process development scientists/engineers
• Proven ability to build, lead and grow a team of technical specialists.
• Strong strategic, data-driven analytical skills with ability to integrate complex considerations in formulating a pragmatic approach towards problem solving
• Excellent cross-functional and stakeholder management skills and ability to develop strong relationships across functions, senior leaders and key stakeholders
• Strong communication and interpersonal skills including ability to prepare and deliver effective presentations and provide information to influence major decisions
  
  

• Lead, direct and manage multiple vaccine, biologics and bio-therapeutics development programs
• Lead and manage multiple vaccines, biologics and bio-therapeutic development programs involving upstream, downstream and analytical activities as per the client requirements
• Ensure the processes are developed, optimized and scaled-up as per the client/project requirements adhering to relevant quality, regulatory and GMP expectations/guidelines
• Design experiments for process development and optimization as per the requirements of the relevant project goals
• Oversee the planning and execution of the relevant experiments and activities on a day-to-day basis including integration of the same across different functions within the process development department
• Manage planning, execution, and tracking of relevant reports and documents related to process development
• Oversee/manage technology transfer of processes both in and out of the organization
• Work and drive programs in accordance with Quality policy of the company.
• Ensure that the teams maintain the equipment & facilities as per the expectations and Quality systems of the organization
• Lead preparation of specific CMC sections of regulatory filings (including INDs, responses to regulatory inquiries etc.)
• Ensure appropriate resources (people/equipment/material etc.) are available and engaged to deliver projects as per the agreed timelines and budgets
• Ensure appropriate data compilation and reports/document preparation for conducted experiments and as per the client/project requirements
• Engagement and interactions with the clients and senior management including preparation and presentation of data, reports and documents in the relevant formats regularly
• Guide and lead members of the team to deliver as per the corporate goals, projects, plans and timelines.
• Recruit, train, grow and mentor members of the team
• Support identification of new business opportunities and preparation of proposals for the new projects including developmental activities, timelines and budget
• Represent the Process Development team both internally and externally
• Prepare and manage department’s operating plans and budget
• Foster a safe and collaborative culture and work environment to ensure the team works together to reach their potential
• Communicate openly and work to the highest levels of ethics, quality and integrity