Manufacturing Associate II- Morning Shift

About the role

The Manufacturing Associate II is a core team member of the manufacturing team, responsible for daily production including environmental monitoring, formulating, and filling of aseptic GMP manufactured products according to batch records and SOPs. This position is for an experienced manufacturing professional with knowledge of GMP, aseptic technique, and problem-solving skills, providing an opportunity to solve challenges in a fast-growing industry.

Responsibilities

Core production duties (70–80% of role):

• Disinfecting and transferring materials and equipment into the cleanroom for production
• Working inside cleanroom suites on your feet for several hours at a time
• Performing environmental monitoring
• Weighing, measuring, and checking raw materials to ensure batches manufactured contain proper ingredients and quantities
• Aseptically filling solutions into finished product containers under sterile conditions
• Performing washing of labware used in GMP manufacture
• Performing cleaning of equipment and classified cleanrooms facility (ceiling, walls, critical surfaces, and floors)
• Performing repetitive tasks while gowned (hood, mask, coveralls, boots, gloves, etc.)
• Operating equipment such as balances, volumetric glassware, peristaltic pumps, filters, pH meter, and pipettes
• Following all SOPs, batch records, and safety policies
• Accurately completing batch record documentation, all appropriate logbook entries, and GMP documentation

Indirect manufacturing support (20–30% of role):

• Performing preventive maintenance on manufacturing equipment
• Performing root cause investigations for Quality issues
• Performing validation activities as needed
• Performing batch record and SOP revisions
• Proposing, championing, and implementing process improvements
• Supporting training program sharing knowledge of process
• Training new manufacturing team members and being a source of knowledge and information
• Real-time review of production records (GDP) ensuring operators are documenting procedures in real time
• May be required to work either day or evening shift as needed
• May occasionally be required to work weekends and overtime as needed
• Required to be on-call for equipment monitoring on a rotation

Requirements

• Bachelor’s degree and 1 year of manufacturing experience; or Associate degree / Biotech certification and 2 years of relevant experience; or High school diploma / GED and 3 years of relevant experience
• Self-motivated and willing to accept temporary responsibilities outside of normal job duties
• Comfortable working in a fast-changing small company environment and able to adjust workload based on changing priorities
• No unusual sensitivity to typical laboratory chemicals (e.g., sanitization agents)
• Ability to perform fast-paced operations and repeatedly perform multi-step simultaneous operations with a high degree of accuracy
• Effective communication while wearing cleanroom gowning (mask, hood, coveralls, gloves, etc.)
• Ability to work effectively in a group and independently
• Ability to meet aseptic gowning qualification requirements
• Ability to work regularly with cleaners
• Ability to lift up to 50 lbs. and push/pull up to 1200 lbs. with assistance

Desirable qualifications

• Familiarity with Microsoft Office programs (Word, Excel, Outlook)
• Familiarity with aseptic processes in a cGMP/FDA regulated environment
• Prior cleanroom gowning experience
• Familiarity with Lean/Six Sigma/5S

Benefits

• Medical, dental, and vision insurance
• 401(k) with generous match
• Life and disability insurance
• Paid time off programs (Vacation and Sick time)
• Potential cash bonus or stock equity grants based on company performance

Pay

US base salary range: $53,766–$75,272 per year (full-time). New hires are typically brought in at or near the midpoint of the range to allow for future growth and advancement. Individual pay is determined by work location, job-related skills, experience, education, and training.

Schedule

Day shift: 5:00 AM – 1:30 PM. May occasionally require evening shift, weekends, overtime, and on-call rotation for equipment monitoring.