Senior Manufacturing Associate I (Swing Shift - 1pm - 9:30pm) *PC 567
About the role
This position is responsible for manufacture of biologics under cGMP conditions. Staff must follow established procedures, execute batch production records using good documentation practices and adhere to gowning procedures required for work in cleanroom environment. Support training new hires, trouble shooting, preparation of controlled documentation and other Manufacturing duties.
Responsibilities
- Adhere to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, modes of operation
- Support manufacturing / production schedules, ensure equipment are available / released for use, maintain manufacturing materials supply to support operations and perform process set up, operations and process monitoring
- Execute batch record instructions, Standard Operating Procedures, complete GMP documentation and assist in reviewing executed batch records for completeness and accuracy
- Assist Manufacturing team Leads in Investigations and corrective actions as required
- Contribute to the development, writing, and review of Standard Operating Procedures (SOPs), Material Specifications (MSs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation
- Responsible for cleaning, proper maintenance and use of production equipment in strict accordance with cGMPs, SOPs and safety policies
- Ensure and maintain inventory and restock supplies when needed
- Assist in troubleshooting processing issues, support investigation and establish root cause and resolution/corrective action
- Collect, trend and analyze process data using MS Excel
Schedule
Swing Shift: 1:00 pm to 9:30 pm, Monday through Friday
Requirements
- Completion of High School
- 2+ years of related experience
- Previous GMP and aseptic technique experience desired
- Regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear
- Required to stand; climb or balance and stoop, kneel, crouch
- Occasionally lift and/or move up to 50 pounds
- Specific vision abilities: close vision, color vision, peripheral vision, depth perception and ability to adjust focus
- Ability to handle more than one task at a time and work at a rapid pace while maintaining attention to detail
Skills
- Ability to articulate production equipment and/or manufacturing process problems to ensure accurate and detailed communication
- Able to provide detailed communication to multiple departments
- Excellent computer skills, verbal and written communication skills at all levels
- Must have Quality and safety mindset and be a fast learner
Work Environment
This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to cultured human cells (immortalized, not primary) and lentivirus-derived vector particles. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, glasses and gloves. The noise level in the work environment is usually moderate.
Pay
Anticipated base salary range: $66,686 ($32.06/hr) – $78,358 ($37.67/hr) per year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training.
Benefits
Comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.