Manufacturing Associate II

Your next role as a Miracle Maker

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a #MiracleMaker to join our Oligo Manufacturing team as a Manufacturing Associate II. As a Manufacturing Associate II you will function as the primary producer for the operational unit and guides new staff members with our technology. Produces research and clinical grade components and products by setting-up, cleaning, operating, and maintaining equipment. Facilitates and executes daily production tasks with team members within ISO classified space.

How you will make an impact:

• Reviews production schedule, studying and clarifying specifications, calculating requirements, assembling materials and supplies, and executing production scheduled tasks
• Prepares production areas for cGMP project initiation or 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
• Writes, reviews, and executes batch records; authors, reviews, and executes SOP revisions; and maintains quality documents
• Mentors and guides associate staff
• 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
• Performs as a leader by training manufacturing personnel and ensuring adherence to production schedule and timeline demands
• Identifies key process bottlenecks and implements continuous process improvements
• Interfaces with manufacturing support groups to align on production requirements
• Troubleshoots processes and implements new processes transferred from process development
• Training manufacturing personnel, troubleshooting production processes, and identifying key process bottlenecks for continuous improvement
• Onboards new equipment with minimal supervision
• May perform fermentation, pDNA linearization, IT reactions, tangential flow filtration and chromatography, using a variety of equipment, including 3L or 30L fermenters, spectrum TFF systems and AKTA HPLCs.
• May perform enzymatic reactions, utilizing purification systems, authoring, and implementing SOPs, and documenting action in batch records
• 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
• May perform Oligo synthesis using automated synthesizers, purification of custom Oligonucleotides (RP, AX, IP, PAGE), Post purification reactions (Amine/ Thiol conjugations), 5'Cap and 5' Triphosphate
• May perform reactions, purifying and processing synthetic oligonucleotides, and documenting actions
• Performs other functions and duties as required

The skills and experience that you will bring:

• Bachelor's Degree in life science field or related field preferably in Chemistry/Biochemistry/Biology/Molecular Biology or equivalent experience
• 2+ years of experience in a Biochemistry manufacturing laboratory
• Exposure in a cGMP/ ISO 7/ ISO 8 clean room environment desired
• 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
• Previous experience with chemical synthesis methodology and purification functionality of mRNA capping reagents, modified NTPs, and biotech supporting raw materials from a 1-500g scale following cGMP procedures desired

The anticipated salary range for this position is $30.00 - $31.50 per hour.  In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package.  The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.