Manufacturing Associate I/II/III, Aseptic Operations

Responsibilities:

The Manufacturing Associate will play a critical role in aseptic processing, formulation, and production of biologics, as well as assisting with bioconjugation processes used in the manufacture of biologic drug substances such as mRNA therapeutics and Bioconjugates (ADCs, Oligoconjugates, etc.).

This role requires experience in aseptic manufacturing techniques, a strong understanding of aseptic bioprocessing principles, and the ability to work effectively in a team-oriented, GMP-compliant environment.  The candidate ensures compliance with Good Manufacturing Practices (GMPs), and contributes to a high-quality, efficient production process. Associates in this role will collaborate with other team members to ensure timely and accurate production while adhering to strict safety and regulatory guidelines. The incumbent works cross-functionally with internal departments and external resources on manufacturing related issues. The Manufacturing Associate supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Aseptic Manufacturing Operations

• Operate, monitor, and maintain aseptic manufacturing equipment (e.g., filling lines, bioreactors, filtration systems (TFFs, aseptic filtration, etc.), purification systems (AKTA) etc. to ensure consistent and compliant production of bioconjugated products.
• Prepare and execute standard operating procedures (SOPs) for aseptic processing, including formulation, filling, and capping.
• Maintain the sterile environment, including monitoring of environmental conditions and performing critical interventions to ensure sterility.
• Obtain environmental monitoring samples as needed
• Assist in the preparation, sterilization, and maintenance of components such as bioreactor bags, filters, and other disposables.

Bioconjugation Support

• Assist in the production and conjugation of biologic molecules, such as ADCs or other biomolecules such as oligoconjugates, mRNAs or other biotherapeutic molecules (drug substance).
• Involved in preparation of reagents, buffers, pack columns as needed.
• Help monitor critical process parameters (CPPs) during the conjugation steps to ensure product quality.

mRNA Manufacturing Support

• Perform operations related to the synthesis, purification, and formulation of mRNA, including the preparation of reagents, buffers, and solutions.
• Assist in the execution of mRNA transcription and purification processes in a cGMP-compliant environment.
• Perform routine IPC testing of mRNA products to ensure quality and consistency.

Documentation and Compliance

• Complete batch records and documentation in accordance with GMP standards and regulatory requirements.
• Assist in investigating and documenting any deviations and participate in CAPA (Corrective and Preventive Action) investigations.
• Maintain accurate records of production activities, ensuring all documentation is completed in a timely and compliant manner.
• Ensure that all manufacturing operations are performed in accordance with company SOPs, GMP, and safety standards. Report any deviations or quality issues to management and assist in investigations.

Equipment Maintenance and Troubleshooting

• Support troubleshooting of equipment malfunctions and coordinate with maintenance personnel to ensure minimal downtime.
• Perform routine maintenance and calibration of aseptic equipment.
• Participate in equipment qualifications as needed.

​​​​​​​Collaboration and Communication

• ​​​​​​​Collaborate with cross-functional teams, including Quality Control (QC), Quality Assurance (QA), Tech Operations, and Engineering, to ensure smooth operation, meeting project timelines, and compliance.
• Actively participate in team meetings, contributing to process improvements and safety discussions.

Environmental Monitoring:

• ​​​​​​​Participate in environmental monitoring activities, including sampling and monitoring air quality, clean room conditions, particulate counts, and maintaining compliance with environmental controls.
• Cleaning of the rooms used in production and documentation of cleaning to maintain compliance with regulatory standards.
• Supervising vendors for cleaning or sampling for microbial testing.

Training:

• Participate in ongoing training programs to stay current with best practices in aseptic operations, equipment handling, and regulatory requirements.

• Perform other tasks and assignments as needed and specified by management.

Requirements:

Required Knowledge, Skills and Abilities:

• Strong technical and troubleshooting skills.
• Ability to work in a fast-paced environment and manage multiple priorities.
• Strong attention to detail and commitment to maintaining high-quality standards.
• Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements (FDA, OSHA, etc.).
• Experience with aseptic techniques and sterile processing procedures.
• Ability to operate and troubleshoot manufacturing equipment in a regulated environment.
• Strong attention to detail, problem-solving, and organizational skills.
• Basic computer skills, including experience with electronic batch records and data entry.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadline
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Education and Experience Requirements:

• High School Diploma or GED required
• Associate’s Degree or higher in a related field (e.g., Life Sciences, Engineering, or Biotechnology) preferred.
• Equivalent work experience may be considered.
• Minimum of 2 years of experience in aseptic manufacturing, biologics, or mRNA production.
• Experience with bioconjugation processes and/or mRNA technologies is a significant plus.
• Knowledge of cGMP (current Good Manufacturing Practices) and regulatory requirements.
• Familiarity with bioreactor operations, aseptic techniques, purification techniques, and sterile filling operations.

Preferred Requirements:

• Experience working with mRNA technologies, including synthesis, purification, or characterization of mRNA products.
• Familiarity with quality control testing methods for bioconjugated products.
• Knowledge of automation systems for aseptic manufacturing.
• Experience with process monitoring and data analysis tools.

Physical Demands:

• Ability to work in cleanroom environments for extended periods.
• Ability to lift upto 30 lbs.
• Ability to lift, bend and stand for extended periods and perform repetitive tasks.
• Must be willing to work 10-hour shifts using PPEs including PAPRs and must gown when inside process suite.

Working Conditions:

This position is based in a manufacturing environment with a focus on aseptic processing in a cGMP-regulated facility. The Manufacturing Associate will work in cleanroom conditions, adhering to all safety, cleanliness, and protocol standards to ensure the highest product quality.

Additional Information:

• This position may require shift work, weekend hours, or on-call responsibilities depending on the production schedule.
• Training in aseptic processing and GMP will be provided as needed.
• The company offers competitive benefits, including health insurance, retirement plans, and paid time off.

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.