Scientist BioPharma Manufacturing MS&T

Purpose:
The candidate will be involved in planning, direction, and execution of projects related with stem cell culture and differentiation. Activities will focus on maintaining and developing robust stem-cell based production and differentiation processes from small (6-well plate) to large (multi-layer Cellstacks or suspension) scales with the appropriate level of compliance and documentation suitable for cGMP manufacture. The candidate will work closely within the team and across functional groups. The candidate should be a highly motivated self-starter who is comfortable working in a hands-on environment.
Essential Job Responsibilities:

• Responsible for experimental study and development plans, preparing required protocols, executing studies, conducting data analysis and preparation of final reports.
• Conducts studies to confirm optimized processes to demonstrate process robust and reproducibility at the appropriate scale required.
• Able to effectively troubleshoots technical issues or process deviations to ensure production proceeds as scheduled.
• Support commercial readiness tasks including process scale-up, process and raw material qualification that meet compliance requirements.
• Duties, responsibilities and activities may change at any time with or without notice

• BS or MS degree in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with relevant experience of 8+ years for BS or 3+ years for MS.
• Extensive cell culture experience with solid knowledge of cell biology principles.
• Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers.
• Detail oriented with good organizational skills and documentation practices.
• Ability to work effectively, independently, as well as part of a team.
• Knowledgeable in process and analytical development, phase appropriate technology transfer, process comparability and qualification, process monitoring and GMPs, ICH, ISPE, and BPE guidelines.
• Ability to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with others.
• Able to work flexible hours including working in weekends.
• This position requires on-site work.

• Deep knowledge and experience with various human cell culture platforms, especially in human pluripotent stem cell culture and differentiation processes towards products for regenerative medicine
• Experience in cell/gene therapy GMP manufacturing, scale-up/scale-down, and tech transfer
• Proficiency in using Microsoft Office software (Excel, PowerPoint, Word), common lab &
• Direct experience on process characterization, development of process control strategy, process qualification and validation
• Understanding of industry expectations with respect to phase appropriate requirements while advancing products from clinical to commercial state