Principal Engineer, MSAT

Position Summary

We are looking for an experienced Principal Engineer of MSAT to join our dynamic team. You will help facilitate the transfer of novel autologous cell therapy technologies from into manufacturing and bring commercialization strategy. You will lead teams and collaborate closely with all partners to ensure seamless technology transfer processes.

This position is based in Santa Monica, CA and reports to the Director MSAT.

We offer the opportunity to join a dynamic biotech startup. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value proactive team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Responsibilities

• Develop and implement comprehensive technology transfer strategies to facilitate the successful transition of processes into GMP manufacturing.
• Author Technical Risk Assessment, Campaign Summary Report to support technology transfer and routine manufacturing activities. Technical writing will be an essential component of this role
• Represent MSAT function at Quality Operations meeting and other meetings
• Create complex dataset using JMP or similar statistical software (control chart and process controls)
• Establish operating ranges and fine tuning of processes to support manufacturing activities
• Develop documentation, including standard operating procedures, batch records, and technology transfer protocols.
• Provide technical expertise and guidance to support manufacturing process troubleshooting and optimization efforts.
• Build and sustain relationships with all partners to meet our requirements.

Education and Experience

• 7+ years with BS/BA; 5+ years with MS/MA; 2+ years with PhD
• Excellent verbal and written communication skills and superior organizational and project management skillset
• Outstanding technical writing skills. Experience with CMC lifecycle and regulatory requirement
• Must have worked in manufacturing, quality or MSAT environment and has the capability of driving risk assessment
• 8+ years working experience in GMP field
• Experience of technical writing skill and understanding of regulatory guidelines

The anticipated salary range for candidates who will work in Santa Monica, CA is$160,000 to $201,000. The final salary offered to a successful candidate will be dependent on several factors that may include the type and length of experience in the job type and length of experience within the industry, education.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.