MSAT Associate

Role Summary: Responsible to provide technical support for the purification processes for different commercial & developmental products such as technology transfer related activities, creating primary document package and CMC deliverables for regulatory filing.

Accountable for process validation and life cycle management for different commercial products including business continuity requirements/initiatives for downstream.

Primary Responsibilities: 1.

Scientific evaluation of process for feasibility, scale up, scale down and direct the technology transfer of downstream process aiming for right first time scale up at manufacturing scale. 2.

Involvement in conducting required studies in process performance qualification (PPQ) batches for drug substance stages and closure of associated documents across the plants. 3.

Preparation and technical review of process/product related investigations and proposal of appropriate corrective & preventive actions along with their implantation within stipulated timeline. 4.

Preparation and technical review of QMS documentation like, investigation reports, change controls and technical write ups (Protocols, reports, risk assessments etc.) for appropriateness of documents. 5.

Involve in process improvements through scientific assessment & implementation of continuous improvement projects. 6.

Responsible for compliance to quality of process. 7.

Responsible for review of process trends and Continued Process Verification for products produced in both microbial and mammalian cell culture manufacturing facilities. 8.

Responsible for audit and regulatory queries management. 9.

Review and coordination with CFTs for CMC aspects of the projects for different regulatory authorities.

Secondary Responsibilities: 1.

To assess the feasibility and implementation of advanced technologies. 2.

Responsible to review assessment of new/alternate vendors and materials.

Educational Qualification A B.Tech. and a Master’s (M.Tech. or M.Sc.) Minimum Work Experience 5-8 years (with Master’s) of experience in a Biopharmaceutical industry Technical Skills Thorough knowledge of Biosimilar, cell-culture, mAb purification processes, and current Good Manufacturing Practices (cGMP).

Proficiency in scaling up manufacturing processes from laboratory-scale to larger production scales and transferring technology between different manufacturing sites at a clinical or commercial facility.

Experience and understanding of Continued Process Verification.

Familiarity and proficiency in using statistical software, particularly JMP, for data analysis, interpretation, and decision-making in the context of process optimization and control.

Expertise in authoring documents related to cGMP and developmental processes, including process validation protocols and reports.

Ability to identify, analyse, and resolve issues or challenges that may arise during the manufacturing process, ensuring continuous improvement.

Skills in conducting risk assessments and comprehensive understanding and application of Quality Management Systems.

Expertise in designing, optimizing, and implementing upstream and downstream processes in a manufacturing environment.

Behavioural Skills Ability to convey complex upstream and downstream processes and technical information clearly to diverse audiences, including team members, management, and cross-functional teams.

Good Interpersonal skills and capacity to work collaboratively with cross-functional teams, like R&D, manufacturing, SCM, quality assurance, regulatory affairs, and others.

Strong analytical and problem-solving skills to address challenges.

Demonstrates integrity by consistently following protocols, exhibiting trustworthiness and reliability.

Takes responsibility and maintains a disciplined and agile approach to execution.