Principal Engineer, MSAT

Job Description

• 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.

Qualifications

• 8+ Years with BS/BA; 6+ Years with MS/MA or MBA • 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

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.