Job Title: Sr. Manager - MSAT
Competencies
Purpose of Job
To support Manufacturing support functions (MSAT) and Life cycle management
Skill Required
Well versed with scientific back ground of different techniques of purification from microbial and cell culture products including drug conjugates
Proficient in both scale down, Scale up and Technology transfer
Openness in adapting and implementing new technologies
Capable of handling and mentoring a team with a clear vision to enhance the productivity
Have undestanding of stastical analysis for Fit model, Comparability tools, trend monitoring tools and hands on expereince on data analysis through JMPor any other application
Have clear understanding and requirements of regulatory expectations in process development and transfer
Skilled in supporting process validation lifecycle, executing pre-validation risk assessment, critical documentation to ensure compliance and manufacturing readiness and process monitoring with different statistical tools
Capabale enough for authoring the scientific justifications based on process understanding in response to regulatory queries
Roles and Responsibilites
Plan and strategize the execution for purification process for process improvement
Working closely with manufacturing team for the support required onsite during technology transfer, risk assessment, facility fit and related document preparation for process validation
Handling the process deviations and root cause analysis with proper CAPA implementation
Working in coordination with manufacturing team to complete the at scale batches, process validation campaign with suppritve documents and further monitoring
Coordinating with R&D team for technology transfer activities including discussions, review of process and control strategy
Authoring and provide guidance to team members for documentation pertaining to life cycle management along with validation activities
Evaluation of alternate strategy/ vendor to reduce the cost of process including single use items along with resins and cassettes
Responsible for risk assessment, study design for Process characterization studies along with statistical findings
Mentoring and guiding the team to comply with the quality system for ensuring the good documntation practices
Working in synergy with the cross functional teams to deliver the functionalities within the time frame
Prioritizing the activities based on the deliverables with man and time management
Act as an SME for scientific justifications and discussions during regulatory audits
Qualification Required
MSC / M.Tech/ Doctoral degree
Relevant skills / Industry experience
Have experience in MSAT/R&D process developement/ Production
Relevant professional / Educational background
MSC/ M.Tech / Doctoral degree
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213