No Open Roles At This Time

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

Scientist, Chemistry

Job Summary

Plan and execute chemical syntheses from milligram to hundreds of grams scales; conduct purification and characterization of compounds; ability to troubleshoot reactions, carry out literature searches using chemical database tools and programs; maintain a detailed and accurate lab notebook; communicate with clients and management on progress and project status; stay abreast of current literature in scientific areas; write project reports containing procedures and experimental details for clients at publication quality; maintain time sheets, equipment, chemical and project inventory and provide lab support.

The incumbent works cross-functionally with internal departments and external resources on research and development related issues. The Scientist, Chemistry supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Plan and execute chemical syntheses from milligrams to hundreds of grams scales.
• Conduct purification and characterization of compounds.
• Carry out literature searches using chemical program databases (i.e. Reaxys, Scifinder).
• Maintain an accurate laboratory notebook according to policy and industry standards.
• Communicate with clients and management on progress and project status.
• Stay abreast of current literature in scientific areas.
• Write project reports containing procedures and experimental details of publication quality for clients.
• Maintain time sheets, equipment, chemical and project inventory and provide lab support.
• Stay up to date with the required SOP and EHS on-line training.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Ability to plan and execute complex multistep syntheses.
• Experienced in purification and characterization of compounds.
• Must have practical and hands-on experience with analytical techniques like Mass Spectrometry and Nuclear Magnetic Resonance.
• Ability to plan and execute work on multiple projects simultaneously.
• Ability to work independently and proactively.
• Ability to work collaboratively as part of a team.
• Communicates effectively with supervisors and colleagues
• Ability to communicate scientific data effectively through presentations and reports internally and externally.
• Experienced in basic computer software and internet applications including: Reaxys, ChemDraw, MS Office suite.
• Demonstrate a willingness for continued learning.
• Maintain a culture of safety within the lab and ensure safe work practices are followed.
• 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 fulfill the business need.

Job Specifications

Education and Experience Requirements

• Ph.D. in Chemistry with 0-2 years of industry/postdoc experience or M.S. in Chemistry with 5-10 years of industry experience.
• Experience working in a Kilo-lab and pilot plant is a plus

Physical Demands

Occasionally required to lift or move objects up to 40lbs

Working Conditions

On-site only, in laboratory majority of time and in office

Certificates & Licenses Required

N/A

Compensation

$85,000- $90,000 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

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

Manufacturing Associate I

Job Summary

The Manufacturing Associate I is responsible for the execution of production activities for early phase small molecule and/or biological programs within a GMP environment. The incumbent works cross-functionally with internal departments and external resources on manufacturing related issues. The Manufacturing Associate I supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Performs manufacturing operations safely and compliantly in accordance with OSHA and cGMP guidelines. Manufacturing operations include but are not limited to, dispensing and sampling of raw materials, buffer preparation, column packing, UF/DF, chromatography, filtration, product sampling, and filling of bulk product or intermediate.
• Assists in biomanufacturing 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.).
• Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.
• Performs oversight of process operations and monitors equipment and critical process parameters.
• Escalates any issues or abnormalities to management, senior associates and/or system matter experts.
• Participates in resulting troubleshooting activities as necessary.
• Completes set-up, use and cleaning (as necessary) of cGMP production equipment.
• Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate.
• Proactively works with senior associates, system matter experts, and management to achieve training competency in production operations.
• Maintains a clean and orderly production area. Positively engages and collaborates with other team members to ensure daily production tasks are completed in a timely manner.
• Participates in investigations of safety or quality issues as necessary.
• Participates and supports a culture of continuous improvement. Effectively collaborates with cross functional partners such as Engineering, Quality Assurance, Quality Control, Supply Chain, and Facilities
• Performs other tasks and assignments as needed and specified by management

Required Knowledge, Skills, and Abilities

• Ability to follow detailed instructions and to maintain accurate records and notes.
• Ability to work effectively in a team environment.
• Energetic, motivated and dynamic individual.
• 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

• BA/BS degree in a scientific discipline (synthetic /organic chemistry)
• 0-2 years of cGMP experience.

Physical Demands

• Typically requires standing and walking for entire shift.
• Occasionally requires lifting of up to 20 pounds
• Frequently requires the use of a step stool
• Requires manual dexterity and visual abilities

Working Conditions

Laboratory and office environment

Certificates & Licenses Required

N/A

Compensation

$20- $25 per hour

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.

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 GMP teams 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.
• 0-2 years of experience in project management in the pharmaceutical/ biotechnology field.
• GMP Planning, Facilities, Engineering, Metrology, and QC experience is a plus.
• Experience with Change control, CAPA, Deviation, Commission and Qualification 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.

R&D Equipment Manager

Job Summary

Under minimal supervision provides front line support for troubleshooting, repair and maintenance of laboratory equipment. The incumbent works cross-functionally with internal departments and external resources on R&D equipment related issues. The R&D Equipment Manager supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Provide subject matter experts (SMEs) front line support for the maintenance, qualification, and repair of multi-vendor scientific equipment (Waters, Agilent, Sciex…etc.)
• Diagnose and resolve multi-vendor scientific equipment problems prior to calling for vendors, third party assistance on non-GMP instruments.
• Maintain all the non-GMP instruments and reduce equipment downtime. Assist with the management of GMP instruments, as needed.
• Assist team leads in the selection, procurement, installation, and maintenance of reaction vessels, rotary evaporators, high vacuum systems, heater/chillers, vacuum pumps, lyophilizers, and other lab equipment.
• Conduct periodic training for scientists on instrument maintenance and usage for optimal performance.
• Work with instrument vendors on scheduling for instruments maintenance, repairs, preventive maintenance, calibrations and qualifications.
• Work with instrument vendors on troubleshooting the instruments associated software’s network issues and updates.
• Periodically backup analytical data from R&D instruments to a secure place.
• Consistently identify, research, and support the onboarding of new in-house equipment.
• Complete assigned workload within predetermined schedules, and performs other duties and responsibilities as assigned.
• Aid leadership in writing, revising and /or implementing processes and procedures.
• Serve as a backup to EHS and Facilities personnel when needed.
• Fill in as needed with other areas of site operations such as Materials Management.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Ability to troubleshoot and problem-solve when training is limited.
• Technical writing and proficiency with Microsoft Office programs.
• Strong attention to detail and critical thinking skills.
• Experience with Good Manufacturing Practices (GMP) concepts and operations.
• Thorough understanding of laboratory facilities, safety rules and best practices.
• Self-motivated and ability to work under pressure to prioritize conflicting deadlines.
• 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

Basic Qualifications:

• Bachelor’s degree (or equivalent) in Engineering, Technical, or Science with 3+ years’ experience servicing laboratory equipment.

OR

Preferred Qualifications:

• Proven experience of a technical support team, preferably in a pharmaceutical laboratory environment.
• Strong troubleshooting skills on multi-vendor equipment
• Working experience with analytical software’s such as Empower, MassLynx, ChemStation, Analyst, etc

Physical Demands

Ability to move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).

Working Conditions

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in the laboratory.
• Job pace may be fast-paced and job completion demands may be high.
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite.
• Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
• Ability to operate computers and other office machinery, such as calculators, copy machines, and computer printers.
• Employee may be required to handle hazardous waste according to local, state, or federal regulations.  Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
• Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.

Certificates & Licenses Required

N/A

Compensation

$80,000- $105,000 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.

Process & GMP Manufacturing Chemist III

Job Summary

Works on multiple steps/multiple projects to execute chemical syntheses from mgs to grams to kilo scales and conduct pilot scale synthesis (kilo scale), purification and characterization of compounds and present results and progress updates to internal and external stakeholders, maintain and clean ab equipment, ensure GMP room maintenance, MBR writing, and perform manufacturing-related activities. The candidate works cross-functionally with internal departments and external resources on process development and GMP manufacturing related issues. The Process & GMP Manufacturing Chemist III supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Should be flexible with small scale and manufacturing execution.
• Perform hands-on laboratory chemical development of robust, safe, and scalable processes for operation in Kilo-lab, pilot plant and GMP suite.
• Participate regularly in cross functional project teams within Research and Development and with external clients as needed (on mg to multi-gram scale projects).
• Works on kilo-lab equipment to prepare pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs) under supervision until fully trained.
• Applies technical knowledge to safely execute synthetic organic chemistry processes for scale up into large glassware, supports and works on pilot plant tech transfers projects for APIs, and HPAPIs.
• Maintain GMP lab equipment and instruments, MBR writing/review and execution plan.
• Documentation of deviations & CAPAs.
• Maintain GMP room status and cleanliness
• Performs pilot scale purifications using Teledyne ISCO purification and Torrent system
• Performs GMP manufacturing of small molecules/ nucleic acids/ antibody conjugate.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Must have full working knowledge of and practical experience with analytical instruments and analytical techniques including HPLC, mass spectroscopy, NMR, and purification systems such as Teledyne ISCO purification and Torrent system.
• Technical knowledge to safely work on synthetic organic chemistry processes for scale up of APIs, HPAPIs at pilot scale is needed.
• Good interpersonal skills to be an effective member of a multi-disciplinary team of chemists, bioconjugation, analytical and quality assurance specialists.
• Has a working knowledge of cGMP process scale-up and familiarity with compliance requirements within cGMP, SOPs, deviations, CAPA and regulatory environment.
• Well versed with GMP lab equipment and instruments.
• Be able to organize work efficiently such that several operations can be carried out simultaneously.
• Ability to be a collaborative team member.
• Ability to apply critical thinking and have good problem-solving skills.
• Demonstrates a willingness to learn and work proactively.
• Able to communicate scientific data effectively through presentations, notebooks, and reports.
• Maintain a culture of safety and ensure safe work practices within the lab.
• Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission.
• Communicates effectively with supervisors and colleagues.
• 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 business need.

Job Specifications

Education and Experience Requirements

• PhD/MS/BS level in Organic Chemistry with at least 6 years of industry experience in pharmaceutical process development for scale up of intermediates and APIs into Kilo-lab, pilot plant and GMP facilities
• Industrial experience developing processes for scale-up of small molecule pharmaceuticals or HPAPI chemicals is preferred
• Experience in a CRO or CMO environment is desirable

Physical Demands

• Ability to work in a cleanroom environment, adhering to strict safety and cleanliness protocols.
• Ability to lift and carry materials up to 30 lbs and perform tasks that may require standing for extended periods.
• Must be willing to work 10-hour shifts using PPEs including PAPRs and must be gowned when inside process suite.
• Physical dexterity sufficient to use pipettes, laboratory equipment, computers and documentation.
• Sufficient vision and hearing capability to work in job environment.
• Must have the ability to work in laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet including PAPRs
• Jewellery, makeup, gum, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and personal protective equipment (PPE) and PAPRs.
• The manufacturing environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
• Reagents, chemicals, and exposure to sanitization agents are expected.
• Restricted areas prohibit food, any outside materials such as cell phones, tablets, at a minimum.

Working Conditions

This role will primarily be based in the GMP manufacturing facility, with periodic office-based work for

reporting and cross-functional collaboration.

Additional Information

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

Certificates & Licenses Required

N/A

Compensation

$100,000- $110,000 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.

Materials Management Specialist

Job Summary

This role is required to purchase materials, consumables, and supplies for R&D, GMP Manufacturing and Process Development. The incumbent works cross-functionally with internal departments and external resources on materials management related issues. The Materials Management Specialist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

General warehouse –

• Source raw materials and consumables from vendors
• Receipt of incoming deliveries and storing under recommended conditions following site procedures.
• When applicable, assigning the material into ChemInventory system to proper personnel.
• Barcoding material container when applicable or providing barcodes with material to scientist to apply.
• Maintaining clean and neat warehouse
• Track orders daily. Contact vendors for issues.
• Collecting completed documents from shipments and storing per site procedure
• Shipping materials via courier companies
• Ensuring label/customs/SDS/other documentation for shipping
• Ensure proper packing of material, proper temperature requirements are met, communication is sent to outgoing requestor / recipient, and preparation of packing list / commercial invoice. Confirm delivery and notify outgoing requestor.

GMP Warehouse –

• Work with GMP manufacturing and PD to order materials.
• Future: Kitting, dispensing and quarantining chemicals.
• Draft specs, gather documents as CoA, BSE/TSE and SDS.
• Confirming receipt of material in appropriate system following GMP receiving procedures to distribution. Receipt includes confirmation that the material(s) have arrived correct, intact, and not tampered with. Removal of most materials from delivery packaging unless the material is packed under specific temperature requirement (dry ice, etc.)
• Organize GMP and R&D items in warehouse and solvent rooms.
• Support GMP equipment orders as needed.
• Maintain updated list of consumables/materials for assets in GMP.
• Inventory maintenance. Constant monitoring of general stock items. Reordering when needed.
• Keeping copies of Safety Data Sheets in binders and also in ChemInventory.

SAP/Ariba –

• Daily monitoring of SAP/Ariba system including approving orders $5,000 or less, ensuring general supply orders are not being placed without reason, following up on backorder items and communicating info to ordering personnel. Completing purchases for personnel via direct order.
• Weekly tracking materials not arrived yet in SAP/Ariba.
• If requested also tracking orders not listed in SAP/Ariba.
• Invoice entry for Cintas, WB Mason and for other vendors as needed.
• Backup for invoice entry as needed.

Other –

• Maintaining a neat, safe working environment.
• Import documentation. Maintaining all import documents for each shipment from NJBIO India.
• Escort garment vendor, document shredding, and dry ice vendor into the building for service. Ordering new lab coats for new employees from garment vendor.
• Dry ice ordering
• Backup for Quarterly inspections of safety showers / eyewashes only if lab specialist and facility superintendent out of office when needed.
• Ensure materials are being refilled in general areas when lab specialist is unavailable.
• Order materials that lab specialist requests for general area supplies.
• Backup for Ordering group lunches and lunches for client meetings and general office supplies.
• Checking mail and distribution daily.
• Assist Materials manager with invoice matching, getting quotes, and sending POs when needed.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Experience with the SAP/Ariba procurement system.
• 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

• Associate degree in Chemistry/ Biology with 3-5 years of experience in Materials Management.
• Bachelor’s degree in Chemistry/ Biology with 1-3 years of experience in Materials Management.

Physical Demands

Ability to lift up to 60 lbs. No restrictions on standing and walking for long periods.

Working Conditions

Office, laboratory and manufacturing environment

Certificates & Licenses Required

N/A

Compensation

$60,000- $80,000 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.

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.

No Open Roles At This Time

Accountant

Job Summary

We are looking for a dedicated and detail-oriented Accountant to join our team. The successful candidate will be responsible for supporting financial reporting, audits, tax and compliance related activities. The incumbent works cross-functionally with internal departments and external resources on accounts and finance related issues. The Accountant supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Preparation of monthly, quarterly and annual financial statements as per the Financial reporting framework
• Assisting in audits / reviews / diligence as may be mandated under various laws
• Prepare financial MIS reports for the management
• Ensuring completeness and accuracy of book keeping and financial records being maintained
• Prepare various reconciliations keep updated schedules for the data reflecting in the accounting software
• Timely submission of accounts to Tax Advisors for Estimated tax evaluation and annual tax return filing
• Assist in timely preparation of monthly customer invoices and tracking receivables
• Maintaining and updating the Fixed Asset Register
• Assist in consolidation of financial statements and keeping financial data updated from various subsidiaries
• Assist in preparation of operational cash flow and reconcile vendor and customer ledgers
• Provide data & reports requested by the management team from time to time
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Proficiency in preparing reports as per the financial framework
• 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.

Job Specifications

Education and Experience Requirements

• Degree in Finance/ Accounting with 5+ years of relevant experience.
• Prior experience of working on SAP platform would be an added advantage.

Physical Demands

N/A

Working Conditions

Office based position.

Certificates & Licenses Required

N/A

Compensation

$65,000- $75,000 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

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