Under minimal supervision, this position is responsible for operation of pharmaceutical manufacturing equipment in a GMP environment for the purpose of making clinical supplies and performing development experiments. Incumbent is also responsible for leading manufacturing activities in assigned production rooms.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Train on, comply with, and understand all policy and procedures at Experic including Regulatory, Safety, SOPs, Work Instructions, etc.
• Assist in the development of new processes in procedures under the management direction including:
  • Becoming subject matter expert for pharmaceutical manufacturing equipment.
• Adapting understanding of equipment into (write) new SOPs and work instructions and assisting in the training of additional staff on equipment specialty.
• Front line troubleshooting of processes and equipment.
• Perform Pharmaceutical Manufacturing activities including:
  • Batch Documentation/Record Generation
  • Materials sampling, staging, dispensing, and return
  • Pharmaceutical Equipment and Room set-up, operation, and cleaning
  • Use of appropriate personal safety equipment and engineering controls
  • In-process inspection and sampling
  • Use Experic IT Platform
• Perform developmental manufacturing experiments under the direction of management.
• Support investigational and quality systems activities.
• Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment.
• Participate in continuous improvement activities at Experic.
• Carries out duties in compliance with all federal and state regulations and guidelines.
• Complies with all company and site policies and procedures.
• Mechanical Aptitude, curiosity to explore complex machinery, and a desire to learn new processes.
• An ability to learn and remain self-directed on tasks that are both well-defined and more exploratory.
• Learn, become and remains current in profession and industry trends.
• Makes a positive contribution as demonstrated by:
  • making suggestions for improvement
  • learning new skills, procedures, and processes.
  • Is available for other duties as required.

QUALIFICATIONS AND EXPERIENCE:

• High School, Trade School, or Vocational Diploma, GED, or equivalent required
• Minimum 3 years of production/manufacturing/packaging experience, including hands‑on experience in primary manufacturing processes OR Minimum 3 years of recent experience as a Production Operator in pharmaceutical manufacturing (solid dosage preferred).

COMPETENCIES/SKILLS:

LANGUAGE SKILLS

• Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
• Legible Handwriting
• Communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.

MATHEMATICAL SKILLS

• Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios, and proportions to practical solutions.
• Graph data using spreadsheets and perform simple statistical analyses (means, standard deviations, linear regression).

REASONING ABILITY

• Identify simple and moderate problems related to job function.
• Scientific Reasoning the ability to gather data based on observations and measurement, formulate hypotheses, propose experimental tests, and draw conclusions, systematically.
• Deductive Reasoning: Demonstrated experience applying general and complex rules to specific problems to produce answers that make sense.
• Inductive Reasoning: Demonstrated experience applying a logical process in which multiple premises, all believed true or found true most of the time, are combined to obtain a specific conclusion (includes finding a relationship among seemingly unrelated events).
• Knowledge of cGMP.
• Familiar with Pharmaceutical Manufacturing.
• Successfully completes regulatory and job training requirements.

Computer skills:

• Enter data into computer using software applications for data entry and word processing. Work and be proficient with e-mail systems.
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• Ability to work individually in a self-directed manner with less than daily oversight.
• Ability to work with others in a team environment.

SUPERVISORY RESPONSIBILITIES:

• No

SCHEDULE:

• Fully Onsite: 5 days in office in Cranbury, NJ.

SALARY:

• $26/hr - $30/hr

WORK ENVIRONMENT:

• Office Environment (standing and sitting) requires minimal physical exertion.

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• The employee must be able to lift and/or move up to 50 pounds is preferred.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral
• vision, depth perception and ability to adjust focus.

TRAVEL:

• Less than 5% of the time.

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected

The Technical Writer is responsible for leading Quality Management System (QMS) documentation activities within Operations. This role will partner closely with Manufacturing, Packaging, Warehouse, Facilities, and Quality Assurance teams to draft, revise, route, and maintain controlled documentation in support of compliant GMP operations. This position serves as a key liaison between Operations and Quality Assurance. The role requires strong technical writing skills, attention to detail, organizational abilities, and familiarity with cGMP documentation practices in a regulated CDMO environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Leads deviation and complaint Root Cause Analysis and CAPA development for GMP investigations.
• Leads change control documentation activities related to Operations.
• Drafts, revises, formats, and coordinates controlled GMP documentation including:
• Coordinates document review, approval, and implementation activities between Operations and QA.
• Partners with cross-functional departments to ensure documentation reflects current operational practices and regulatory expectations.
• Supports document control activities within the electronic QMS/document management system.
• Assists with document periodic reviews, revisions, obsolescence activities, and version control.
• Ensures documentation is accurate, compliant, clear, and inspection ready.
• Assists with maintaining GMP documentation standards and data integrity expectations.
• Coordinates with QA regarding documentation corrections, audit findings, and continuous improvement initiatives.
• Supports internal and external audit readiness activities.
• Participates in operational meetings and provides documentation support for process improvements and new implementations.
• Maintains organized records and documentation archives in accordance with company procedures.

• SOPs
• Batch records
• Forms
• Work instructions
• Logbooks
• Protocols
• Training documentation

• Coordinates document review, approval, and implementation activities between Operations and QA.
• Partners with cross-functional departments to ensure documentation reflects current operational practices and regulatory expectations.
• Supports document control activities within the electronic QMS/document management system.
• Assists with document periodic reviews, revisions, obsolescence activities, and version control.
• Ensures documentation is accurate, compliant, clear, and inspection ready.
• Assists with maintaining GMP documentation standards and data integrity expectations.
• Coordinates with QA regarding documentation corrections, audit findings, and continuous improvement initiatives.
• Supports internal and external audit readiness activities.
• Participates in operational meetings and provides documentation support for process improvements and new implementations.
• Maintains organized records and documentation archives in accordance with company procedures.

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s degree preferred in Life Sciences, Engineering, Technical Writing, or related field; equivalent experience may be considered.
• 3+ years of experience in a pharmaceutical, biotechnology, medical device, or other regulated GMP environment.
• Experience leading GMP investigation, including Root Cause Analysis methodologies, required.
• Experience authoring and/or coordinating GMP documentation required.
• Familiarity with cGMP requirements, GDP principles, and FDA regulatory expectations required.
• Prior experience supporting GMP manufacturing and packaging, strongly preferred.
• Experience working with Quality Management Systems (QMS) and document control systems preferred.

COMPETENCIES/SKILLS:

• Strong technical writing and document formatting skills.
• Excellent attention to detail and organizational skills.
• Ability to manage multiple document workflows and timelines simultaneously.
• Strong collaboration and communication skills across departments.
• Working knowledge of GMP documentation standards and data integrity principles.
• Proficiency in Microsoft Office applications and electronic document management systems.
• Ability to interpret operational processes and translate them into compliant written procedures.

SUPERVISORY RESPONSIBILITIES:

• None

SCHEDULE:

• In Office Role: 5 days in office in Cranbury, NJ office

SALARY RANGE:

• Market range:
  • Mid/Senior level – 3+ years - $80,000 - $110,000

WORK ENVIRONMENT:

• Office Environment (standing and sitting) requires minimal physical exertion.

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• The employee must be able to lift and/or move up to 25 pounds.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

·       Less than 5% of the time. 

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Under minimal supervision, this position is responsible for operation of pharmaceutical manufacturing equipment in a GMP environment for the purpose of making clinical supplies and performing development experiments. Incumbent is also responsible for leading manufacturing activities in assigned production rooms.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Train on, comply with, and understand all policy and procedures at Experic including Regulatory, Safety, SOPs, Work Instructions, etc.
• Assist in the development of new processes in procedures under the management direction including:
  • Becoming subject matter expert for pharmaceutical manufacturing equipment.
• Adapting understanding of equipment into (write) new SOPs and work instructions and assisting in the training of additional staff on                 equipment specialty.
• Front line troubleshooting of processes and equipment.
• Perform Pharmaceutical Manufacturing activities including:
  • Batch Documentation/Record Generation
  • Materials sampling, staging, dispensing, and return
  • Pharmaceutical Equipment and Room set-up, operation, and cleaning
  • Use of appropriate personal safety equipment and engineering controls
  • In-process inspection and sampling
  • Use Experic IT Platform
• Perform developmental manufacturing experiments under the direction of management.
• Support investigational and quality systems activities.
• Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment.
• Participate in continuous improvement activities at Experic.
• Carries out duties in compliance with all federal and state regulations and guidelines.
• Complies with all company and site policies and procedures.
• Mechanical Aptitude, curiosity to explore complex machinery, and a desire to learn new processes.
• An ability to learn and remain self-directed on tasks that are both well-defined and more exploratory.
• Learn, become and remains current in profession and industry trends.
• Makes a positive contribution as demonstrated by:
  • making suggestions for improvement
  • learning new skills, procedures, and processes.
  • Is available for other duties as required.

QUALIFICATIONS AND EXPERIENCE:

• High School, Trade School, or Vocational Diploma, GED, or equivalent required
• Minimum 3 years of production/manufacturing/packaging experience, including hands‑on experience in primary manufacturing processes OR Minimum 3 years of recent experience as a Production Operator in pharmaceutical manufacturing (solid dosage preferred).

COMPETENCIES/SKILLS:

LANGUAGE SKILLS

• Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
• Legible Handwriting
• Communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.

MATHEMATICAL SKILLS

• Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios, and proportions to practical solutions.
• Graph data using spreadsheets and perform simple statistical analyses (means, standard deviations, linear regression).

REASONING ABILITY

• Identify simple and moderate problems related to job function.
• Scientific Reasoning the ability to gather data based on observations and measurement, formulate hypotheses, propose experimental tests, and draw conclusions, systematically.
• Deductive Reasoning: Demonstrated experience applying general and complex rules to specific problems to produce answers that make sense.
• Inductive Reasoning: Demonstrated experience applying a logical process in which multiple premises, all believed true or found true most of the time, are combined to obtain a specific conclusion (includes finding a relationship among seemingly unrelated events).
• Knowledge of cGMP.
• Familiar with Pharmaceutical Manufacturing.
• Successfully completes regulatory and job training requirements.

Computer skills:

• Enter data into computer using software applications for data entry and word processing. Work and be proficient with e-mail systems.
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• Ability to work individually in a self-directed manner with less than daily oversight.
• Ability to work with others in a team environment.

SUPERVISORY RESPONSIBILITIES:

• No

SCHEDULE:

• Fully Onsite: 5 days in office in Cranbury, NJ.

SALARY:

• $26/hr - $30/hr

WORK ENVIRONMENT:

• Office Environment (standing and sitting) requires minimal physical exertion.

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• The employee must be able to lift and/or move up to 50 pounds is preferred.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral
• vision, depth perception and ability to adjust focus.

TRAVEL:

• Less than 5% of the time.

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected

Under minimal supervision, the incumbent is responsible for the project management of assigned clients including but not limited to the planning of project resources, assembling, or leading the project team, time management, budget, scope, quality and satisfaction, risk management, monitoring progress, documentation, and reporting.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Management of project related activities from definition to launch stage to ensure that projects are delivered on-time, within approved budget and achieves project objectives.

• Organize and lead project core team meetings.

• Maintains effective communication and working relationships among project core team.

• Ability to translate clinical trial synopsis / clinical trial protocol into an efficient and cost-effective plan including, but not limited to:

Material Management

Manufacturing, Packaging & Labeling - Prepare documents such as, but not limited to, material specifications and batch records.

• Prepare required distribution documentation, enter & monitor shipments.

• Prepare required Returns, Accountability and Destruction documentation.

• Manage all project related inventory to avoid stock out scenarios.

• Work with cross-functional team members to assess feasibility of project scope and objectives and develop detailed project timeline to ensure that there is enough flexibility and contingency in the plan to respond to unanticipated difficulties.

• Define and assign schedules and track cross-functional tasks/activities to ensure that project progress within expected timings.

• Management of monthly project invoicing.

• Identify, monitor, communicate and resolve issues, scope changes, budget variances or other project objective hurdles that may arise during the project execution.

• Interface with all functional areas of the business to ensure timely, effective, and efficient execution of project tasks.

• Lead risk analysis & mitigation planning for projects.

• Prepare and present project progress reports and presentations as required.

• Carries out duties in compliance with all federal and state regulations and guidelines.

• Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.

• Remains current in profession and industry trends.

• Makes a positive contribution as demonstrated by:

• making suggestions for improvement

• learning new skills, procedures, and processes.

• Is available for other duties as required.

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s Degree preferred. 

• At least five (5) years of project management experience in packaging, labeling and clinical supply chain as Project Manager.

• Commercial packaging experience a plus.

COMPETENCIES/SKILLS:

• Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.

• Legible Handwriting

• Communicate clearly in writing and orally.

• Demonstrate practical knowledge of 21 CFR 210, 21 CFR 211, 21 CFR Part 11, Eudralex Volume 4, and Annex 13.

• Demonstrate effective collaboration and teamwork.

• Demonstrate experience managing contract pharmaceutical projects on time and on budget.

• Demonstrate experience working in a cGxP environment.

• Familiar with project management tools and technologies such as Microsoft Project.

• Knowledge of various project management methodologies.

• Successfully completes regulatory and job training requirements.

• Computer skills:

• Enter data into computer using software applications for data entry and word processing.

• Work and be proficient with e-mail systems.

• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.

• Ability to work with others in a team environment.

SUPERVISORY RESPONSIBILITIES: 

• None

SCHEDULE:

• In Office Role: 4 days in office in Cranbury, NJ office, 1-day WFH.

SALARY:

• $100,000 to $125,000

WORK ENVIRONMENT:

• Standard office environment 

PHYSICAL DEMANDS:

• Office Environment (standing and sitting) requiring minimal physical exertion.

TRAVEL:

• Domestic travel will be required less than 5% of the time. 

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by l

The Technical Writer, Analytical is responsible for supporting and coordinating Quality Management System (QMS) documentation activities for the laboratory and Analytical functions. This role will partner closely with laboratory personnel and Quality Assurance to draft, revise, route, and maintain compliant GMP laboratory documentation supporting analytical testing and development activities. This individual will serve as a key liaison between Analytical R&D and Quality Assurance for laboratory quality documentation and related quality system activities. The role requires strong technical writing capabilities, scientific comprehension, and familiarity with GMP laboratory documentation practices in a regulated pharmaceutical or CDMO environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Drafts, revises, formats, and coordinates-controlled laboratory documentation including:
  • SOPs
  • Test methods
  • Specifications
  • Analytical procedures
  • Forms
  • Protocols
  • Laboratory worksheets
  • Validation documentation
• Coordinates document review and approval workflows between Analytical R&D and QA.
• Supports document control activities within the electronic QMS/document management system.
• Assists with laboratory-related deviations, investigations, CAPA, and change control documentation.
• Partners with laboratory personnel to ensure procedures accurately reflect current analytical practices and regulatory requirements.
• Supports data integrity and GDP compliance initiatives within laboratory documentation practices.
• Assists with maintaining inspection-ready documentation and audit preparedness.
• Coordinates document revisions, periodic reviews, archival activities, and implementation of updated procedures.
• Supports onboarding and training documentation activities related to laboratory procedures.
• Maintains organized documentation records in accordance with company procedures and regulatory expectations.
• Participates in continuous improvement initiatives related to laboratory documentation and quality systems.

QUALIFICATIONS AND EXPERIENCE:

• Bachelor’s degree preferred in Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, Technical Writing, or related discipline.
• Minimum 2–5 years of experience in pharmaceutical, biotechnology, medical device, or other regulated GMP laboratory environments.
• Experience authoring and/or coordinating GMP laboratory documentation required.
• Familiarity with analytical laboratory operations and documentation practices preferred.
• Experience with Quality Management Systems (QMS) and electronic document management systems preferred.
• Working knowledge of cGMP, GDP, FDA regulations, and data integrity expectations required.

COMPETENCIES/SKILLS:

• Strong technical and scientific writing skills.
• Ability to interpret analytical and laboratory processes into compliant documentation.
• Excellent attention to detail and organizational abilities.
• Strong collaboration and communication skills across technical and quality teams.
• Ability to manage multiple projects and documentation timelines simultaneously.
• Proficiency in Microsoft Office applications and electronic quality/document management systems.
• •Understanding of GMP laboratory documentation requirements and data integrity principles.

SUPERVISORY RESPONSIBILITIES:

• None

SCHEDULE:

• Hybrid: 4 days in office in Cranbury, NJ office; 1-day WFH.

SALARY RANGE:

• $100,000 - $130,000

WORK ENVIRONMENT:

• Office Environment (standing and sitting) requires minimal physical exertion.

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• The employee must be able to lift and/or move up to 50 pounds frequently.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral
• vision, depth perception and ability to adjust focus.

 TRAVEL:

•  Less than 5% of the time.