MSAT Specialist - Upstream

Job Summary
We are seeking a skilled professional to serve as a specialist in upstream/downstream operations, specializing in processes like mammalian cell culture, perfusion technology, scale-up, single use technology, Bioreactor characterization, Chromatography, Ultrafiltration, and Virus Filtration. The role involves authoring validation protocols, conducting risk assessments, utilizing tools for process verification, and actively participating in technology transfers to ensure compliant, efficient, and continuously improved manufacturing processes.

Roles & Responsibilities

. You will serve as a Subject Matter Expert (SME) and actively engage in hands-on operations involving processes like cell culture, tech-transfer from lab to manufacturing scale, Chromatography, Ultrafiltration, TFF, Virus Filtration, and handling drug substance.
. Your responsibilities include authoring process validation protocols and reports, conducting risk assessments, utilizing tools like Continued Process Verification (CPV), PAT Tools, and statistical analysis tools (e.g., JMP).
. You will be responsible for generating various documents related to process monitoring, investigating incidents for Deviations, and working with Quality Management Systems (QMS).
. Your role also involves active participation in technology transfers and implementing upstream/downstream processes including facility fit modelling based on process needs.
. You will build, modify, and utilize digital data storage, visualization, and analysis systems such as Minitab and/or JMP and custom web-based interfaces to enable site process monitoring and continuous process verification programs.
. You will be responsible for ensuring compliance, control, cost-effectiveness, and continuous improvement of manufacturing processes.

Educational qualification: A B.Tech. and a Master's (M.Tech. or M.Sc.) or a Ph.D.

Minimum work experience: 5-10 years (with Ph.D.) or 7-15 years (with Master's) of experience in a Biopharmaceutical industry

Skills & attributes:
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.