POSITION OBJECTIVE:

The Sr. Manager/ Process Engineer will support the manufacture of Drug Product (fill finish, device assembly and secondary packaging) of biologics product. The activities range from tech transfer, technical process studies, process validation activities, data analysis to handing 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.

YOUR TASKS AND RESPONSIBILITIES:

• Lead and oversee the operational activities at DP/FG/Device Assembly CMOs; scheduling of batches, commercial manufacturing and testing of DP

• Responsible to achieve 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 optimization 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 commercialization

• Plan and forecast budgets, analyzing 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

• Other duties as assigned

WHO YOU ARE:

• B.E./BTech, MS or Ph.D. degree in (bio) chemical engineering, biotechnology

• Doctorate degree 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 impact on product quality specifications is advantageous.

• 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

Job Location: Sun House, Mumbai

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.