No Open Roles At This Time

Scientist, Process Development

Job Summary

Under minimal supervision 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, stay abreast of current literature in scientific areas, maintain equipment, chemical inventory and lab support and Perform duties as required. The incumbent works cross-functionally with internal departments and external resources on process development related issues. The Scientist, Process Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Perform hands-on laboratory chemical development of robust, safe, and scalable processes for operation in Process and/or Kilo-labs under minimal supervision.
• Participate regularly in cross functional project teams within Research and Development and with external clients as needed (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 minimum supervision.
• Applies technical knowledge to safely optimize synthetic organic chemistry processes for scale up into large glassware, supports and works on pilot plant tech transfers projects for APIs, and HPAPIs.
• Regularly characterizes molecules using analytical techniques including NMR, MS, HPLC independently.
• Under minimal supervision, performs pilot scale purifications using normal phase and reverse phase chromatography systems.
• 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 optimize synthetic organic chemistry processes for scale up of APIs, HPAPIs at pilot scale is needed.
• Has a working knowledge of cGMP process scale-up and familiarity with compliance requirements within cGMP, SOPs, and regulatory environments.
• Demonstrates a willingness to learn and work pro-actively.
• Able to communicate scientific data effectively through presentations, notebooks, and reports internally and externally.
• 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.
• 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

• PhD/MS level in Organic Chemistry
• 0-2 years of industrial experience in pharmaceutical process development for scale up of intermediates and APIs into Kilo-lab and pilot plant facilities.
• 1-2 more years 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

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

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.

Senior Scientist, Process Development

Job Summary

Independently work on multiple steps/multiple projects to execute multiple chemical syntheses from hundreds of grams to kilos scales and conduct pilot scale synthesis (kilo scale) purification and characterization of compounds and present results and progress updates to internal and external stakeholders, stay abreast of current literature in scientific areas, maintain equipment, chemical inventory and lab support and Perform duties as required. The incumbent works cross-functionally with internal departments and external resources on process development related issues. The Senior Scientist in Process Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Performs laboratory chemical development of robust, safe, and scalable processes for operation in Kilo-lab independently.
• Design, synthesis, and purification of compounds (small and complex molecules, payload, linkers, APIs, etc.) – typically 5-7 reactions including pilot and scale up with 3-5 purifications weekly.
• Participates regularly in cross functional project teams within Research and Development and with external clients (mg to multi-gram scale projects) and in group meetings and communicates results, data, verbally and written.
• Works independently on kilo-lab equipment to prepare pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs) and performs purifications using normal phase and reverse phase chromatography systems.
• Applies technical knowledge to safely optimize synthetic organic chemistry processes for scale up into large glassware, supports and works on pilot plant tech transfers projects and for multiple batch use for APIs, and HPAPIs independently.
• Regularly characterizes molecules using analytical techniques including NMR, MS, HPLC, LCMS and providing clients with high-quality technical documents (SDS, COCs, product data sheets, reports, etc.) in an accurate manner.
• Researching synthetic routes through literature searches and search databases.
• Documenting experiments in notebooks accurately and following site GDPs.
• Ordering materials correctly for projects, chemical inventory and safe storage of chemicals.
• On-site Training, and maintaining safety, GLPs, and GMPs, as needed.
• Following safety protocols while handling cytotoxins, properly disposing solid and solvent waste.
• Supervising scientists, includes mentoring, developing and training, monitoring their progress on projects.
• Supporting lab equipment as needed and safety inspections as needed.
• 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 optimize synthetic organic chemistry processes for scale up of APIs, HPAPIs at pilot scale is needed.
• Has a working knowledge of cGMP process scale-up and familiarity with compliance requirements within cGMP, SOPs, and regulatory environments.
• Demonstrates a willingness to learn and work pro-actively.
• 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.
• Knowledge of literature search databases and ChemDraw.
• 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

• PhD/MS level in Organic Chemistry
• 2-4 plus years of industrial experience in pharmaceutical process development for scale up of intermediates and APIs into Kilo-lab and pilot plant facilities (GMP)
• 3 or more years industrial experience developing processes for scale-up of small molecule pharmaceuticals or HPAPI chemicals is preferred (GMP)
• Experience in a CRO or CMO environment is desirable

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

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

Manufacturing Associate I/II/III, Aseptic Operations

Job Summary

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.

Job Responsibilities

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.

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 deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Job Specifications

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.

Certificates & Licenses Required

• N/A

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.

Equipment and Facilities Engineer

Job Summary

The Equipment and Facilities Engineer will be responsible for supporting the operations, maintenance and repair activities of a GMP facility and R&D laboratory operations. The ideal candidate will bring expertise in facilities management, critical utilities, and project management. This role calls for a proactive leader who can work collaboratively with stakeholders, including QA, QC, Manufacturing, Materials Management, Safety, Laboratories, IT, and other departments, to ensure operational excellence and compliance. Furthermore, the Equipment and Facilities Engineer is responsible for maintaining a safe, efficient, and compliant work environment by supporting adherence to GMP standards, company Standard Operating Procedures (SOPs), and regulatory requirements.

Job Responsibilities

• Supervise and escort vendors responsible for the maintenance and repair of GMP and non-GMP facility-related equipment and critical utilities, including boilers, chillers, air compressors, vacuum systems, DI water systems, electrical systems, fire alarms, security systems, and other building-related systems.
• Ensure all maintenance/repair works are completed to standards and that the work area is cleaned thoroughly upon completion
• Manage preventive maintenance (PM) services, equipment repair, work orders, deviations, and change control processes related to the facility.
• Support SOP revisions to capture essential PM service procedures and reflect the current operation of various facility equipment, and critical utilities.
• Coordinate with area users to plan and schedule facility cleanings (including classified cleanrooms) and PM services that impact operations such as the shutdown of an HVAC.
• Supervise vendors performing the facility cleaning and maintenance tasks.
• Review and forward PM service reports for facility equipment, and critical utilities to management for final approval. Add reports to Facility SharePoint.
• Generate, execute, and close work orders in a timely manner for various facility equipment, and critical utilities.
• Perform daily and monthly inspections of facility equipment, as well as critical utilities, using equipment PM checklists.
• Work with site QA and Manufacturing to evaluate facility related GMP issues, assist in risk assessments, support deviations, assist in root cause analysis, and implement corrective actions.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Excellent leadership and communication skills for managing stakeholders, contractors, and resolving conflicts.
• Proficient in Building Automation Systems (BAS) and Environmental Monitoring Systems (EMS).
• Expertise in troubleshooting and investigating HVAC and critical utilities equipment.
• Experience with boilers, chillers, air compressors, electrical systems, vacuum systems, air handlers, refrigeration systems, fire alarms, sprinkler systems, emergency generators, security systems, and other related systems.
• Knowledge of OSHA and company safety requirements (e.g., equipment lockout/tagout, confined space), safe work practices, and other safety regulations.
• Experience supervising contractors.
• Ability to read and interpret facilities and critical utilities drawings.
• Quick learner with strong equipment troubleshooting and problem-solving skills.
• Outstanding interpersonal skills for effective collaboration with cross-functional teams and stakeholders.
• Capable of working efficiently in a fast-paced and dynamic environment.
• Prefer someone with a strong understanding of change control, CAPA, deviation management, and GMP cleaning protocols.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Critical 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

• Bachelor’s degree in engineering or a related field in Facilities Management, with experience preferred in pharmaceutical, biotechnology, or chemistry lab facilities. Appropriate experience can be used to replace education requirement.
• At least 3 years of experience in GMP facilities, laboratories, equipment maintenance, and facilities project management.
• A New Jersey Boiler Operator’s License is preferred for this role.

Physical Demands

• Ability to lift heavy objects (≤50 lb.) and perform other labor-intensive tasks as required.
• 50% Sitting and 50% Standing and Walking

Working Conditions

• Mechanical spaces, including areas near boilers, chillers, HVAC, and other critical and non-critical building-related systems
• Laboratory/Manufacturing environment including areas with high potent materials
• Outside

Certificates & Licenses Required

• New Jersey Boiler Operator’s License preferred

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.

VP, Manufacturing/ Technical Operations

Job Summary

The Vice President, Manufacturing/ Technical Operations (MTO) will be responsible for developing NJ Bio’s strategic manufacturing/technical start-up operations roadmap, which also includes activities that support Good Manufacturing Practices (GMP). These activities include production operations, facility, capital engineering (commissioning, equipment, facility buildout/expansion), process engineering (manufacturing sciences and technology (MSAT), qualification/validation, technical operations, EHS, and warehouse management and maintenance. This individual will engage and develop the MTO team and explore technical partnerships with academic and other organizations/institutions to stay at the forefront of manufacturing technologies. The candidate is expected to roll up their sleeves to perform or implement policies, procedures and strategies as required by operations. The incumbent works cross-functionally with internal departments and external resources on manufacturing/ technical operations related issues. The VP, Manufacturing/ Technical Operations accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Lead, develop, implement, and execute a global manufacturing strategy that is aligned with NJ Bio’s expectations to provide high-quality clinical supplies to clients.
• Build, develop, and lead a department that has the capability to manufacture multiple active pharmaceutical products (API) including high-potent APIs (HPAPI), mRNAs, drug substances (DS), and Antibody Drug Conjugates (ADCs) following GMP standards.
• Oversee, and as required, perform and implement all the activities that support the manufacturing of GMP materials such as facility, capital engineering (commissioning, equipment, facility buildout/expansion), process engineering (manufacturing sciences and technology (MSAT), qualification/validation, master validation plan, warehouse management and maintenance.
• Oversee/implement the department’s finalization of manufacturing campaigns and engineering projects.
• Develop short- and long-term technical objectives for the organization that cover manufacturing and engineering.
• Lead and manage NJ Bio’s manufacturing efforts, collaborating closely with appropriate stakeholders to ensure alignment with the company’s timelines.
• Establish project/program milestones and timelines to drive programs through solid leadership, empowerment, and accountability, ensuring that goals are met on time and within budget.
• Contribute to evaluating customer/partnership at an early stage.
• Work with senior leadership to evaluate customers/clients and recommend decision on manufacturing capability and assist in pricing for services.
• Serve as the technical (manufacturing and engineering) lead for manufacturing partnerships/collaboration.
• Serve as the technical operations (manufacturing and engineering) due diligence lead for business development activities.
• Provide guidance on manufacturing matters to customers/clients/partners/collaborators.
• Represent the company, addressing aspects of the company’s manufacturing capabilities.
• Partner with Quality colleagues and implements appropriate QA/QC process and controls; has a QA/QC first mindset.
• Partner with Process R&D colleagues to ensure technical transfer of manufacturing process from lab/pilot scale to GMP.
• Ensure regulatory inspection preparedness planning for customer/client, investor and regulatory agency visits and inspections while understanding and implementing processes, controls, and methods that align with global health authority regulatory expectations.
• Maintain the operational facility at a high level of cGMP compliance per FDA, EMEA and customer expectations.
• Ensure that all operations are always compliant with EHS Standards and OSHA and EPA requirements.
• Promote and ensure a safety culture with areas of responsibility.
• Manage, coach, and mentor direct reports.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Strong background in manufacturing multiple active pharmaceutical and biologic products (API) including high-potent APIs (HPAPI), mRNAs, drug substances (DS), and Antibody Drug Conjugates (ADCs)
• Hands-on experience working in GMP environment and clinical manufacturing
• Leadership experience of teams is required.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Ability to influence without direct authority
• 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 degree in chemistry, biology, biochemistry, engineering or related discipline.
• 10 years of experience in a GMP manufacturing or CRO setting and leadership experience required.

Physical Demands

• Requires standing and walking.
• Occasionally requires lifting of up to 20 pounds.
• Requires manual dexterity and visual abilities.

Working Conditions

Office based position with ability to occasionally work in laboratory.

Certificates & Licenses Required

N/A

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 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.
• 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.
• 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

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.

Validation Support Specialist

Job Summary

The Validation Support Specialist is responsible for performing qualification and/or validation activities to support the cGMP biopharmaceutical/ pharmaceutical manufacturing at NJ Bio. This role is responsible for writing and executing protocols for process equipment and facility systems, as well as process and cleaning validations. The Validation Support Specialist conducts qualification/validation activities for projects within timelines and complies with the requirements of NJ Bio’s EHS requirements, OSHA requirements, applicable cGMPs and other regulations. The Validation Support Specialist will assist in review of all documents which support the qualifications. The incumbent works cross-functionally with internal departments and external resources on validation/ qualification related issues. The Validation Support Specialist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Assists with the development of Validation Master Plans
• Prepares installation, operational and performance qualification protocols for new or modified processes, systems, or equipment in support of the GMP manufacturing process.
• Works independently to execute, or cordinate execution of, validation protocol activities with affected departments, personnel and/or third-party vendors.
• Develop and execute protocols for Process and Cleaning validations.
• Assists with computer validation to meet FDA 21CFR part 11 compliance.
• Performs risk assessments, root cause investigations; write deviations, change controls, and CAPAs, and/or assist with the writing based on sound engineering principles.
• Performs reviews of URS, SOP and documents supporting the qualification activities
• Assist with authoring SOPs and Work Instructions as applicable.
• Maintain communication with cross-functional teams including Manufacturing, Facilities, Quality Assurance, and Project Management to achieve all project deliverables.
• Maintain databases for tracking validation activities.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Able to do participate in cleanroom gowning and PPE, as required by site procedures.
• Is passionate about continuous improvement.
• Able to understand and verify piping & instrument diagram, engineering layout, drawing and other engineering documents.
• Knowledge of Good Documentation Practices, Pharma GxPs, cGMPs, Engineering Qualification Procedures, tools for Risk Assessment, FMEA, others are a must.
• Proficiency with Microsoft Office
• Excellent verbal communication, technical writing and presentation 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

• Bachelor’s degree in engineering, pharmaceutical manufacturing, chemistry, biotechnology, or related scientific discipline required.
• A combination of equipment qualification, process validation, cleaning or computer validation may be acceptable.
• Stays abreast of Industry guidelines, US and international regulations for validation of GMP facilities.

Physical Demands

N/A

Working Conditions

Office based position.

Certificates & Licenses Required

N/A

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

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.

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No Open Roles At This Time

No Open Roles At This Time

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