Team Lead - Cell Culture

Job summary
We are seeking a dedicated professional to lead team activities, supervise lab maintenance, and manage people within the upstream process development function of Biologics. This role involves ensuring on-time delivery of experiments for one/two biosimilar molecules, with a focus on drafting and timely closure of technical reports to meet team deliverables.

Roles & Responsibilities
. You will be responsible for leading and managing the overall scientific, technical, and operational efforts of team members, including guiding teams for the successful execution of experiments, and ensuring the quality of data meets global expectations.
. You will oversee lab operations and equipment maintenance, actively participate in lab meetings, contribute to troubleshooting potential causes for experimental failures, and coordinate upstream process development for one/two Biosimilar projects within the function.
. You will be responsible for planning resource requirements to meet project deliverables providing guidance and direction to team members to ensure project schedules are met with quality technical success. You will be responsible for collaboration with various stakeholders within and across teams is crucial for meeting project timelines.
. You will contribute to performance reviews of team members, identify their developmental needs, communicate them to the responsible authority, and maintain discipline within the team.
. You will be responsible for data collation, analysis, and interpretation, drawing logical scientific conclusions, and generating technical presentations to communicate technical information within the function.
. Your role includes drafting scientific reports for team deliverables, such as process development summaries, technical memos, and process description summaries, maintaining global quality and adhering to regulatory standards with support from team members and group leaders to fulfill functional requirements and support regulatory filings.
. You will be responsible for assuming ownership of specialized process equipment, escalating lab issues for technical support, ensuring compliance with safety standards, supervising safety and lab systems, and verifying the appropriate following of protocols.
. Additionally, you'll oversee inventory updating, troubleshoot problems related to equipment, and ensure smooth development work in the lab.

Educational qualification: A Ph.D. or Master's degree (M.Sc. or M.Tech. or M.E. or M.Pharm.) or Bachelor's degree (B.Tech. or B.E. or B.Pharm.) in Biology, Chemical Engineering, Microbiology, Biotechnology, Biochemistry, Biochemical Engineering or other related disciplines of engineering or life sciences.

Minimum work experience: 2 years of industrial experience with a Ph.D., 6 years with a Master's, or 9 years with a Bachelor's

Skills & attributes:

Technical Skills
. In-depth understanding of cell culture process development for Biotherapeutics/Biosimilars, stays informed about current trends in the Biopharma industry, and exhibits a basic understanding of the regulatory framework and IP (Intellectual Property) landscape.
. Can perform comprehensive data analysis of processes and provide logical conclusions and recommendations.
. Knowledge of bioreactor operation in batch/fed-batch/perfusion modes.
. Understanding of chemical engineering principles applicable to biotechnology.
. In-depth understanding of mammalian cell culture physiology and metabolism for Biosimilar product development.
. Demonstrates Design of Experiments (DOE) and statistical analysis skills using various tools.
. Understanding of FDA (Food and Drug Administration), EMA (European Medicines Agency), ICH (International Council for Harmonisation), and other regulatory bodies guidelines for Biosimilar development.

Behavioural skills
. Strong supervisory, team management, and motivational skills, effectively leading and guiding teams.
. Strong learning orientation, staying updated with current practices in the subject area.
. Good interpersonal skills, fostering positive relationships and effective communication.
. Adaptability to a dynamic environment, showcasing flexibility and resilience in response to changes.