Job Description

Job Title:
Sr. Manager - Process Engineer- Biologics External Manufacturing
Business Unit:
External Manufacturing and Supply Biologics
Manager Title:
Head - External Manufacturing and Supply Operations Biologics
Location:
Sun House, Mumbai
At Sun Pharma, we commit to helping you "Create your own sunshine"- by fostering an environment where you grow at every step, take charge of your journey, and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."
Key responsibilities:
The Sr. Manager/ Process Engineer will support the manufacture of Drug Product (fill finish, device assembly and secondary packaging) of a biologics product. The activities range from tech transfer, technical process studies, process validation activities, data analysis, to handling change controls, deviations and troubleshooting. Writing and reviewing of DP/Device Assembly/FG validation-related documents and key CMC sections of regulatory dossiers (different countries) are also required for this position.
Major Duties/Responsibilities

• Lead and oversee the operational activities at DP/FG/Device Assembly CMOs; scheduling of batches, commercial manufacturing and testing of DP
• Responsible for achieving on-time in-full manufacturing of DP/FG/Device Assembly in compliance with approved dossiers in collaboration with Quality Assurance, Regulatory Affairs, and Analytical teams
• Serve as DP Subject Matter Expert (SME) on multidisciplinary CMC teams to ensure scientifically driven development and optimisation of biological processes
• Review and approve master batch records, change controls, and deviations, CAPA to ensure GMP compliance and operational success
• Preparation and review of documents such as CPV reports, risk assessments, technical reports, validation documents, deviation reports and regulatory modules
• Responsible for Continuous Process Improvement and Process Optimization to reduce Cost of Goods
• Responsible for Tech Transfer and Process Validation into commercialisation
• Plan and forecast budgets, analysing variances for production and development testing and execute the day-to-day financial activities in accordance with procedures and contracts.
• The candidate will communicate across the organization to ensure key stakeholders are aware of project status, potential risks and their required action plans.
• Supporting post-launch market surveillance of the product

Professional Experience

• Doctorate with 1-3 years of related experience - or- Master's degree and 3-5 years of related experience - or- Bachelor's degree and 5-7 years of direct experience in Biologics Drug Product GMP manufacturing
• Experience in cGMP Biologics Drug Product is a must
• Knowledge of statistical tools like Minitab/JMP for data analysis is required
• Knowledge of analytical testing methods and their impact on product quality specifications is advantageous

Skills & Abilities:

• Excellent interpersonal and communication, presentation skills
• Excellent organizational and project management skills, work well under pressure
• Ability to diagnose complex issues; develop and implement solutions by collaborating with other teams.
• Ability to influence internal and external stakeholders through scientific justifications
• Ability to thrive in a small group setting with limited administrative support

Travel Estimate
Job Requirements
Educational Qualification
B.E./BTech, MS or Ph.D. degree in (bio) chemical engineering, biotechnology
Experience
5 years of experience in Manufacturing, Factory/CMO management
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Skills Required