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.

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

No Open Roles At This Time

Executive Administrative Assistant

Job Summary

This position is responsible for providing exemplary Executive-level support. The incumbent works cross-functionally with internal departments and external resources on administrative issues. Responsibilities include managing calendars, phones and emails, and developing/ implementing process improvements. Creates and maintains effective workflow and communications to accomplish the work of the management team which includes the handling of a variety of projects and tasks simultaneously. Schedules, plans, and coordinates meetings including making presentations, planning agendas, booking rooms, special events, developing or collating presentation materials, reviewing minutes and next steps, as well as developing action items. Completes special projects as assigned. The Executive Administrative Assistant supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities

• Creates & maintains effective workflow and communications to accomplish the work of the executive management team including handling of a variety of projects and tasks simultaneously.
• Manage senior leadership calendars, review, and respond to emails, and schedule simple (e.g., 1 on 1s) to more complex meetings (i.e., monitoring client/prospect meeting requests, etc.) either as on site or virtual meetings.
• Develop & maintain strong, credible relationships across company executives, support teams and clients, anticipate, and respond quickly to changes and encourage others to do the same.
• Screen incoming emails & route correctly to proper executive for action, direction, or follow-up.
• Schedules, plans, coordinates executive staff meetings including making presentations, reviewing drafts for language, grammar, formats, planning & sharing agendas, booking rooms, special events, developing or collating presentation materials, reviewing minutes, next steps, assigning action items and follow ups.
• Maintain confidential information, records, files, and maintain the highest level of confidentiality.
• Manage domestic & international travel schedules for executives & support expense reporting.
• Completes special projects as assigned.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills, and Abilities

• Must be a high-performing & experienced professional with a high level of integrity & confidence.
• Must be highly organized, possess exceptional administrative, verbal, & written communication skills.
• Ability to prioritize, plan, and multitask, track activities of department, senior leaders, and must be excellent at setup of multiple meetings with internal members and clients independently.
• Seek challenges, anticipate needs, and be self-motivated.
• Expert knowledge of Microsoft Office, especially PowerPoint, Outlook, SharePoint, Teams, Zoom, and internet search engines and able to learn systems and procedures quickly.
• Ability to carry out all functions in accordance with pre-established procedures and team up with colleagues to meet deadlines established for the Department.
• Ability to discreetly handle sensitive and confidential material.
• Strong organizational savvy.
• Must effectively manage conflicting priorities, be adaptable, and comfortable in a fast-paced environment.
• Proven track record of assisting industry executives.
• Good understanding of domestic and international travel management.
• At least 10 years of administrative support experience is required.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint).
• 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

• Bachelor of Science, Business Administration and Management or equivalent bachelor’s degree and atleast 10 years administrative or comparable experience or an equivalent combination of both education and experience which meets the required knowledge, skills, and abilities.
• Prior Executive Assistant experience preferred.

Physical Demands

N/A

Working Conditions

On-site full-time; Office environment at our Princeton, NJ location.

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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