Manufacturing Associate II

Bachelor’s Degree in life science field or related field preferably in Chemistry/Biochemistry/Biology/Molecular Biology or equivalent experience preferred
2+ years of experience in a chemistry or biochemistry manufacturing laboratory
1+ years of experience in a cGMP/ ISO 7/ ISO 8 clean room environment preferred
Experience with drafting, editing, implementing, and executing SOPs
Proficiency in Microsoft Office Suite desired
Display strong organizational skills, detail-oriented, and demonstrated problem-solving abilities
Excellent written and verbal communication skills
Self-motivated and able to organize and prioritize multiple tasks

Reviews production schedule, assembling materials and supplies, and executing production scheduled tasks
Prepares production areas for cGMP campaign initiation or product changeover
Documents production by accurately completing forms, reports, logs, and records of equipment and batches following GDP
Keeps equipment operating by following instructions, troubleshooting breakdowns, executing regular preventative maintenance, and calling for repairs
Updates batch records and SOPs for minor corrections
Participates in training opportunities and ensures timely completion and compliance with cGMP and all other relevant company training requirements
Maintains safe and clean work environment by SOPs
Provides written and verbal updates to supervisors and/or other department managers
Supports continuous process improvements
Interfaces with manufacturing support groups to align production requirements
Collaborates cross-functionally with MS&T to refine training for the new processes transferred from process development and MS&T
May perform gram-kg chemical synthesis, organic reactions, precipitations, salt exchanges, extractions, deprotections, liquid chromatography (analytical, small, pilot, and large-scale skids), fill finish, and aliquoting of mRNA capping reagents, modified NTPs, and biotech supporting raw materials