No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

Assistant Project Manager

Job Summary

We are looking for a dedicated and detail-oriented Assistant Project Manager to join our team. The successful candidate will be responsible for supporting project management activities, ensuring projects are completed on time, within scope, and on budget, while maintaining high levels of customer satisfaction and collaboration. This position requires it to be onsite the vast majority of the time. The incumbent works cross-functionally with internal departments and external resources on project management related issues. The Assistant Project Manager supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Communicate with external clients and internal stakeholders, coordinate meetings, conduct meetings, record meeting minutes, and organize and store meeting files and documents in designated locations.
• Develop and manage a detailed project schedule and work plan, tracking project scope, timelines, status, and budget to ensure on-time and on-budget delivery of projects. Adjust timelines as needed.
• Keep clients and project teams updated with progress reports and up-to-date information on the project.
• Collaborate with the Business Development team and contribute to their activities as needed.
• Partner with management to support safety and quality initiatives within the organization.
• Utilize industry best practices, techniques, and standards throughout the entire project execution.
• Develop and maintain strong collaborative working relationships and interact effectively with all levels within the organization and with external clients.
• In emergency cases (During GMP operations), the employee is expected to be available virtually or in some cases onsite, during holidays, weekends, and early/late hours.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Outstanding interpersonal skills with a demonstrated ability to effectively build positive working relationships across functions.
• Well-versed in basic project management principles, including identifying critical paths, building and communicating timelines, defining milestones, and setting expectations and accountability.
• Self-motivated with a willingness to grow and learn new skills.
• Proficiency in MS Project is recommended.
• Proficiency in using Smartsheet for project management is a plus.
• May occasionally require working beyond regular business hours to accommodate international clients.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills as well as interpersonal 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 deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

Job Specifications

Education and Experience Requirements

• BS, MS, or PhD in Chemistry, Biochemistry, Biology, Health Sciences, or other related disciplines is a plus.
• Analytical R&D and QC experience is a plus.
• PMP Certificate is a plus.
• Smartsheet experience is a plus.

Physical Demands

N/A

Working Conditions

Office based position.

Certificates & Licenses Required

PMP Certificate is a plus

Compensation

$65,000- $68,000 per annum

Confirm Job Qualifier To Apply

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.

Facility Mechanic

Job Summary

The Facility Mechanic ensures smooth functioning of all facility systems, utilities, conducts regular inspections of building systems, and PMs, repairs, and assists in directing activities of subcontractors, including overseeing their activities. The individual in this role also ensures that work conforms to specifications, performs quality control, verifies compliance with safety and regulatory requirements, and provides on-site direction and ensures contractors are trained on site procedures. The incumbent works cross-functionally with internal departments and external resources on facility related issues. The Facility Mechanic supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Perform repair and maintenance to the NJ Bio facility and systems in accordance with NJ Bio’s high safety and appearance standards, and ensures optimum efficiency and reliability of electrical, mechanical, automation, utility, data and information technology systems.
• Responsible for the routine maintenance and upkeep of the entire facility with respect to the following areas: Heating and air conditioning (HVAC), Laboratory Exhaust Systems, Water and Plumbing, Lighting, Electrical (including back-up generator, UPS System, and Substation), Security and Alarms, Card Key Access Control, General upkeep and repairs, General Safety, and Information Technology (Computers, Networks, etc.).
• Check facilities systems to identify problems, add to MaintainX, and repair; ensure building is operational and maintain logs.
• Work with internal stakeholders and third party resources to develop and maintain preventative maintenance procedures and schedules for the maintenance for the facilities and related equipment.
• Monitor, track and coordinate all corrective and preventative maintenance work activity and inspects/reviews outside contractor work and provides internal approval for payment.
• Perform HVAC, electrical, plumbing, carpentry and other minor repairs as ceiling tile replacement, painting, etc.
• Coordinate with contractors, escort them, verify work order completion and maintain paper and electronic records.
• Assess the needs of the facility with respect to maintenance and upkeep of the physical facility and communicate with Management, Production and the Quality Unit with observations and recommendations on a periodic basis.
• Work with outside contractors and township for building and process related construction projects.
• Provide training materials to contractors and ensure trainings are completed before work commences.
• Communicate about issues to supervisor on facility equipment.
• Replace belts and filters on HVAC systems, small motors, lighting ballasts, and bulbs.
• Assemble, disassemble equipment, move and dispose of equipment like furniture, heavy equipment etc. and fix equipment issues.
• Light fabrication of minor parts for equipment.
• Train on and follow assigned site EHS and HR procedures.
• Escort Contractors and supervise them when on site and ensure they follow safety procedures.
• Ensure all PM reports, repair tickets and any other equipment reports for facilities are stored electronically on a regular basis in approved shared site.
• Review work performed by contractors and provide for approval to supervisor.
• Assistance in Company/ Facility Events/ Functions: setting up tables, moving chairs etc.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Ability to identify mechanical problems preventatively prior to equipment failures.
• Knowledge of GMP and OSHA requirements.
• Demonstrated skills for organizing all scopes, people, material, and equipment to successfully manage projects.
• Ability to communicate verbally and in writing at all levels inside and outside the organization.
• Basic knowledge of electrical, mechanical, and structural systems.
• Computer skills, commensurate with Essential Functions, including the ability to learn a validated system; proficient in the use of personal computers.
• Basic knowledge of uploading and managing web-based document storage.
• Willingness to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.
• Ability to consistently work a late first shift (approx. 11 am to 7 pm).
• Ability to work under specific time constraints.
• Willing to learn and admit knowledge or experience gaps.
• Ability to interact in an effective and appropriate manner with diverse population sets.
• Ability to communicate candidly, clearly and timely.
• The following would be a plus:
• Class A / pharmaceutical building knowledge
• Siemens Insight BAS knowledge
• Knowledge of LOTO procedures
• Knowledge of safe working practices
• Office casework knowledge
• Spanish speaking
• Proficiency with Microsoft Office.
• 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 deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

Job Specifications

Education and Experience Requirements

• HS/GED degree with over 5 years of relevant experience with applicable certification; or HS/GED degree with 6 or more years of relevant experience with Master Trade License.
• An equivalent combination of education and experience in facility management may be accepted as a satisfactory substitute for the specific education and experience listed above
• Facility maintenance, HVAC, inventory management and vendor management experience.
• Experience with building management, fire alarm / control, and facility water purification systems.

Physical Demands

This position requires climbing, bending, stooping, walking, sitting, and lifting up to 75 lbs.

Working Conditions

• Mechanical Spaces including close proximity to boilers and HVAC systems.
• Laboratory/Manufacturing environment including areas with high potent materials.
• Outside

Certificates & Licenses Required

• Boiler operator’s license (LP required, HP preferred)
• Valid driver’s license

Compensation

$58,000- $65,000 per annum

Confirm Job Qualifier To Apply

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.

*We kindly request that agencies and recruiters do not contact us regarding this position.

Manufacturing Associate I/II/III, Biological Operations

Job Summary

We are seeking a highly motivated and skilled Manufacturing Associate, Biological Operations in a cutting-edge biomanufacturing facility focused on bioconjugation and the production of mRNA-based therapies. The Manufacturing Associate will play a critical role in ensuring the aseptic processing, 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 manufacturing techniques, including a strong understanding of aseptic and low bioburden bioprocessing principles, and the ability to work effectively in a team-oriented, GMP-compliant environment. ensuring compliance with Good Manufacturing Practices (GMP), and contributing 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.

Job Responsibilities

• Manufacturing Operations
  • Operate, monitor, and maintain aseptic and low bioburden 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 and mRNAs.
  • 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.
  • 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 and 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 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.
• Performs other tasks and assignments as needed and specified by management

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 technique and sterile processing procedures.
• Ability to operate and troubleshoot manufacturing equipment in a regulated environment.
• Basic computer skills, including experience with electronic batch records and data entry.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal 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 deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

Job Specifications

Education and Experience Requirements

• Associate’s or Bachelor’s degree in Biological Sciences, Biotechnology, Bioengineering, or related field. High School Diploma or GED required; Associate’s Degree or higher in a related field (e.g., Life Sciences, Engineering, or Biotechnology) preferred.
• Minimum of 2 years of experience in aseptic manufacturing, bioconjugated products, 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.
• Familiarity with quality control testing methods for bioconjugated and mRNA products preferred.
• Knowledge of automation systems for aseptic and low bioburden manufacturing preferred.
• Experience with process monitoring and data analysis tools preferred.

Physical Demands

• Ability to work in cleanroom environments for extended periods.
• Ability to lift up to 30 lbs.
• Ability to 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 and low bioburden 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.

Certificates & Licenses Required

N/A

Compensation

$20- $40 per hour (based on level)

Confirm Job Qualifier To Apply

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.

*We kindly request that agencies and recruiters do not contact us regarding this position.

Manager/ Sr. Manager, Facilities & Engineering

Job Summary

The Manager/ Sr. Manager, Facilities & Engineering will provide technical and engineering support for critical utilities and facilities used in GMP manufacturing. This role will lead the design, implementation, and maintenance of new and existing utility systems, ensuring reliable and compliant operations that support pharmaceutical manufacturing and product quality. He/ she will collaborate cross-functionally with Facilities, Engineering, Manufacturing, Quality, and external vendors to optimize systems performance, resolve technical issues, and drive continuous improvement in facility and utility operations. The incumbent works cross-functionally with internal departments and external resources on facilities and engineering related issues. The Manager/ Sr. Manager, Facilities & Engineering supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Lead the design and layout of plant systems, utilities, and manufacturing areas (e.g., cleanrooms, process suites, utilities and solvent storage and handling).
• Plan, coordinate, and execute engineering analysis related to pharmaceutical plant operations and process/equipment optimizations. Develop strategy and processes to support 24X7 operations, including troubleshooting and optimization of equipment operational issues, preventive maintenance and system upgrades.
• Interface with stakeholders, vendors, and contractors to align designs and current operations with technical requirements and operational schedules.
• Provide technical expertise in clean and plant utilities, including HVAC, WFI, autoclaves, purified water, clean steam, and clean gas systems.
• Develop, update and review engineering documentation such as design specifications, P&IDs, User Requirements, Functional Specifications, protocols (FAT/SAT/IQ/OQ/PQ), SOPs, and reports.
• Plan and execute preventive and corrective maintenance programs for utility and facility systems.
• Serve as subject matter expert (SME) in the areas of plant utilities, facilities, engineering and manufacturing equipment.
• Lead identification, root cause and resolution issues, including all aspects of deviation investigations, change control, and CAPAs.
• Monitor utility performance through data analysis, statistical methods, and reliability assessments.
• Collaborate with internal and external stakeholders to ensure systems meet technical, operational, and GMP compliance standards.
• Act as a liaison between the Facilities & Engineering team, manufacturing operations, and quality departments.
• Ensure all activities adhere to FDA, GMP, OSHA, and other applicable regulatory requirements.
• Support continuous improvement projects to enhance system performance, energy efficiency, and reliability.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• In-depth understanding and knowledge of clean utility systems (WFI, purified water, clean steam, clean gases) and plant utilities (HVAC, boilers, chilled water, cooling towers, process chillers).
• Knowledge of GMP, FDA, and OSHA standards applicable to pharmaceutical manufacturing.
• Ability to interpret and develop engineering drawings (P&IDs, equipment layouts, GA drawings).
• Requires relevant work experience in Utilities Systems, Facilities equipment, Building Management/Control Systems (BMS), design, build and operational support.
• Must have strong attention to technical details including engineering life cycle principles, with strong mechanical, instrumentation, electrical and process hands on capabilities.
• Strong troubleshooting and problem-solving skills with a focus on root cause analysis.
• Excellent technical writing and documentation skills.
• Strong collaboration, project management, and communication abilities.
• Mechanical, electrical, and process systems hands-on capabilities.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal 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 deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as required to fulfill business needs.

Job Specifications

Education and Experience Requirements

• Bachelor’s degree in Mechanical, Chemical, Biochemical, or Engineering Technology, or related field.
• 10+ years of relevant engineering or facilities experience.
• Minimum of 5 years of GMP experience preferred.

Physical Demands

• Ability to stand, walk, sit, reach, climb, balance, stoop, kneel, crouch, or crawl as required.
• Ability to lift and/or move up to 40 pounds.
• Requires hearing, vision, and speaking within normal ranges for communication and inspection activities.

Working Conditions

• Mechanical Spaces including close proximity to boilers and HVAC systems.
• Laboratory/Manufacturing environment including areas with high potent materials.
• Outside

Certificates & Licenses Required

N/A

Compensation

$125,000- $135,000 per annum

Confirm Job Qualifier To Apply

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.

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

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