Head Process Development

JOB OVERVIEW:
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.

REPORTING STRUCTURE:
Will report to CEO and COO

QUALIFICATION:
Postgraduate or PhD degree in a relevant Science or Engineering field

EXPERIENCE:
20 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

KEY ROLES AND RESPONSIBILITIES:

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

PIRAMAL SUCCESS FACTORS:

Thinks big
Contributing to strategic initiatives, generating and executing new ideas & Supporting team members to deal with change. Building & balancing long term and short term
goals and translating strategy into action.

Commits and delivers results
Leading initiatives, developing plan for self/team, persistent and taking ownership to support business growth. Planning and mobilizing resources, Monitoring business
results and tracking performance of team.

Collaborates
Facilitating collaborative work environment, prioritizing team goals, Building relationships across organization and consensus within team. Understanding group
dynamics and encouraging collaboration.

Serves Customers
Understanding and driving customer needs to deliver and manage customer expectations. Adding value and maintaining relationships beyond deliverables.
Identifying emerging customer needs and building feedback mechanism to address customer expectation.

Displays Humility
Treating team members with respect and dignity, being transparent and driving humility as core value. Acknowledging and accepting diverse opinions from team
members.

Empowers and develops
Providing regular feedback and understanding strengths and development areas of team members. Sharing expertise, encouraging others to take up responsibilities,
building processes for continuous and timely feedback.

Postgraduate or PhD degree in a relevant Science or Engineering field