R&D DS: Upstream Manager

Job Title: R&D DS: Upstream Manager

Qualification: M.Sc. in Biotechnology
Experience: 12+ years
Department: R&D-DS

Key Responsibilities

Management & Planning

• Prepare detailed monthly plans for experimentation and resource allocation (manpower, materials, equipment).
• Manage scheduling, training, and optimal utilization of resources and personnel.
• Ensure uninterrupted experimentation and batches through proper coordination and staffing.
• Regularly review activities and report to Head-Upstream for process improvements.
• Assist in preparing and adhering to financial budgets.
• Oversee new product development and resource planning for the same.
• Implement corrective actions for meeting departmental goals and organizational objectives.

Technical & Process Oversight

• Lead the development and optimization of upstream processes for biosimilars and novel biotherapeutics.
• Conduct DOE-based experiments, analyze data, and optimize processes (Seed/Fermentation/Recovery).
• Scale-up processes and manage technology transfer to higher scales.
• Assess and implement recent technologies for cost-effective biotherapeutic development.
• Ensure compliance with cGMP, GLP, and regulatory standards.
• Identify process gaps and areas for improvement in PDL and Pilot Plant.

Employee Development & Leadership

• Supervise, mentor, and coach shift supervisors and team members.
• Ensure comprehensive on-the-job training (OJT) for all employees.
• Foster teamwork, discipline, and a positive work environment.
• Resolve conflicts and maintain harmony within the department.

Documentation & Compliance

• Ensure high-quality documentation and timely completion of process development, scale-up, and technical reports.
• Manage document initiation/revision (LNB, batch protocols, SOPs) in line with GDP.
• Prepare for audits and ensure compliance with industry standards.

Interdepartmental Coordination

• Coordinate with Engineering, QC, QA, SCM, Production, and external vendors for process optimization.
• Collaborate with external experts to evaluate new technologies, raw materials, and equipment.

Safety & Compliance

• Enforce safety protocols and ensure the team adheres to PPE usage and safe work practices.
• Proactively address any unsafe conditions or operations.

Key Requirements

• Experience: 12+ years in Upstream R&D (focused on fermentation, recovery, and process development in biopharma).
• Leadership: Strong managerial skills, with experience leading teams and driving results.
• Technical Expertise: In-depth knowledge of biosimilars, process development, scale-up, and technology transfer.
• Process Optimization: Proven ability to conduct DOE-based experiments and optimize upstream processes for therapeutic proteins.
• Compliance: Expertise in cGMP, GLP, and ICH guidelines (Q7, Q8, Q9, Q10).
• Problem-Solving: Strong analytical skills and ability to identify and address process inefficiencies.
• Team Development: Experience in coaching, mentoring, and training teams for improved performance.
• Communication: Excellent written, oral, and interpersonal communication skills.
• Safety: Commitment to promoting safety culture and ensuring workplace safety compliance.Role & responsibilities