Manufacturing Manager

Associate Manager - MSAT

Bangalore, India

Position Description :

Biosimilar Mammalian MSAT

Responsible for and single point of contact for downstream process from manufacturing plant

Able to guide, train, mentor and manage team. Guiding teams to evaluate and execute new manufacturing technologies and effective transfer of processes and technologies. Ensuring support for dossier preparation, regulatory filing.

Ensure audit readiness, identify risk associated with audit, mitigation of identified risks.

Planning and facilitating scale-up, technology transfer, process validation, cleaning validation, etc. activities.

Continuous monitoring and review of the downstream process of the DS manufacturing process. Analyze, anticipate, respond to, and resolve process issues that arise during manufacturing.

Performing continued process verification to ensure that the process is under validated state of controls and it delivers consistent product quality and yield consistently.

Evaluate downstream manufacturing process and institute process improvement / optimization, overcome bottlenecks and productivity / throughput increase, COGS reduction initiatives and evaluation and implementation of new technologies wherever applicable.

Effectively work and communicate with team, CFTs and partners for planning and execution of downstream process improvement activities and formulation / review / revision of procedural controls and procedures in the processes and its implementation in the manufacturing process.

Authoring / reviewing of process / QMS / process part of regulatory filing documents. Participate and lead in cross-functional root cause analysis and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, and CAPA).

Process data collection and advanced data analysis skill, data interpretation and support for decision making.

Follow and adhere to rules, regulations and procedures, data integrity and compliance in performing the assigned activities.

Education & Requirements :

B Tech or M Tech in Biotech / Biochemical / Chemical or MSc Biotech / M Pharma

A min of 8 years of relevant experience with Biopharma MSAT or R&D experience.

Downstream manufacturing experience is mandatory for this role.

Extensive experience with GMP, cGMP, Regulatory Affairs, compliance, QC etc.

Experience in managing a team is essential for this role.