Engineering Jobs in Plainsboro New Jersey

Position: Formulation Scientist

Location: Onsite in Skillman, NJ

Duration: 1 year Contract

Overview

The Formulation Scientist will support the Skin Health R&D team, contributing to both innovation and base business (commercialized products) within the skincare portfolio. This role will focus on formulation development, lab execution, and scale-up activities for consumer skincare products, including anti-aging formulations.

The ideal candidate will work under the guidance of senior scientists while also taking ownership of experiments, technical problem-solving, and project execution.

Key Responsibilities

• Support end-to-end product development for skincare formulations, including innovation and commercialization of existing products
• Execute laboratory experiments, including formulation development, testing, and analysis of skincare products
• Assist in product design, formulation optimization, and process development/scale-up activities
• Conduct Design of Experiments (DOE) to support investigations and product improvements
• Process formulated products at lab scale and support transition to manufacturing
• Collaborate cross-functionally with R&D, manufacturing, and external partners to support project execution
• Analyze consumer insights and contribute to innovation pipeline development
• Maintain accurate documentation, including technical reports and experimental data
• Ensure compliance with company procedures, cGMP standards, and regulatory requirements
• Support troubleshooting efforts related to formulation, supply disruptions, or product upgrades

Required Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmacy, or related field
• 1–4 years of experience in formulation development (academic or industry)
• Experience with personal care, cosmetic, OTC, or pharmaceutical products
• Strong foundation in formulated systems (emulsions, surfactants, suspensions, structured liquids)
• Hands-on laboratory experience executing experiments and processing formulations
• Understanding of material chemistry and basic process equipment
• Experience supporting process development or scale-up activities
• Strong communication, documentation, and organizational skills
• Proficiency in MS Office (Excel, Word, PowerPoint)

Preferred Qualifications

• Experience formulating skincare or anti-aging products
• Familiarity with cGMP and regulatory standards
• Experience working with external manufacturing partners
• Exposure to technical project management or cross-functional collaboration
• Ability to work independently while contributing within a team environment

Title: Early Career Recruiter

On-site – East Windsor, NJ

We are looking for recent graduates or early-career professionals who are interested in starting a career in Technical Recruiting / Talent Acquisition. This role offers hands-on training, mentorship, and growth into a full-cycle recruiter role.

What You'll Learn & Do:

Learn how to recruit for software, IT, and engineering roles

Work closely with senior recruiters and hiring managers

Source candidates using LinkedIn, job boards, and internal databases

Screen resumes and conduct initial candidate interviews

Coordinate interview schedules and follow-ups

Support onboarding and offer processes

Build candidate pipelines and maintain recruiting data

Represent the company at career fairs and campus events

Ideal Candidate:

Recent graduate or up to 1–2 years of experience

Bachelor's degree in HR, Business, Marketing, Psychology, or related field

Strong communication and interpersonal skills

Interest in recruiting, HR, or talent acquisition

Organized, eager to learn, and comfortable talking to people

Basic computer skills (MS Excel, Word, LinkedIn)

What We Offer:

Structured training & mentorship

Clear growth path to Technical Recruiter / Senior Recruiter

Exposure to US staffing & IT hiring

Visa sponsorship available

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Director of Manufacturing Science & Technology (MSAT) will lead the technical oversight, process lifecycle management, and technology transfer activities for cell therapy manufacturing programs within a CDMO environment. This role is responsible for ensuring robust, scalable, and compliant manufacturing processes for autologous and allogeneic cell therapy products from clinical development through commercial manufacturing.

The Director will work cross-functionally with Process Development, Manufacturing, Quality, Regulatory, Supply Chain, and Client Program teams to support client programs, drive continuous process improvement, and ensure successful technology transfers into GMP manufacturing.

This role is based in Princeton, NJ and is fully onsite.

Key Responsibilities

• Provide scientific and technical leadership for cell therapy manufacturing processes, including upstream cell expansion, gene modification, harvest, formulation, and cryopreservation.

• Serve as the technical subject matter expert (SME) for manufacturing processes supporting client programs.

• Lead troubleshooting efforts and root cause analysis for manufacturing deviations, investigations, and CAPAs.

• Drive implementation of process monitoring and control strategies.

• Lead technology transfer activities from clients or internal process development teams into GMP manufacturing.

• Develop and review technology transfer plans, process descriptions, risk assessments, and gap analyses.

• Ensure successful scale-up and scale-out of manufacturing processes across CDMO facilities, as applicable.

• Oversee continued process verification (CPV) and lifecycle management for manufacturing processes.

• Lead process characterization, comparability studies, and validation support activities.

• Provide real-time technical support to GMP manufacturing operations for clinical and commercial batches.

• Review batch records, deviations, and change controls related to process changes.

• Present technical updates during client meetings and governance reviews.

• Support proposal development, technical due diligence, and onboarding of new client programs.

• Ensure MSAT activities comply with cGMP, FDA, EMA, and ICH regulatory requirements.

• Contribute to regulatory filings, including INDs, BLAs, and comparability packages.

• Support regulatory inspections and client audits.

• Build and lead a high-performing MSAT team, including scientists and engineers.

• Provide mentorship, technical guidance, and performance management.

• Develop MSAT strategy aligned with organizational growth and client pipeline.

• Perform other duties as assigned by the Head of Development.

Required Qualifications

• PhD or MS in Biochemical Engineering, Cell Biology, Bioengineering, Biotechnology, or a related field.

• 10–15+ years of experience in biopharmaceutical manufacturing or process development.

• 5+ years of leadership experience in MSAT, technical operations, or process development.

• Strong experience in cell therapy manufacturing (e.g., CAR-T, TCR-T, NK cells, stem cell therapies).

• Experience working within a CDMO environment strongly preferred.

• Deep knowledge of:

• Cell culture and expansion technologies

• Viral vector transduction or gene editing workflows

• Closed and automated cell therapy manufacturing platforms

• Cryopreservation and fill-finish processes

• Experience with technology transfer, process validation, and process characterization.

• Familiarity with statistical process monitoring and data analytics tools.

• Strong cross-functional leadership and project management skills.

• Experience working directly with biotech clients.

• Excellent written and verbal communication skills.

• Ability to operate in a fast-paced CDMO environment supporting multiple client programs.

Preferred Qualifications

• Experience with commercial cell therapy manufacturing.

• Experience with automated manufacturing platforms (e.g., CliniMACS Prodigy, Lonza Cocoon).

• Knowledge of viral vector manufacturing processes.

• Experience supporting BLA submissions or late-stage clinical programs.

Physical Requirements

• Ability to perform essential job functions in compliance with ADA, FMLA, and other applicable regulations, including meeting productivity standards.

• Ability to maintain regular and punctual attendance.

• Must be willing to become gown-qualified and work in BSL-2 lab, CNC, ISO7, and ISO8 environments.

• Ability to lift and carry up to 30 lbs.

• Ability to bend, stoop, reach, climb, and stand on elevated surfaces as needed.

• Ability to sit or stand for extended periods.

• Must be comfortable working with cell-based products, chemicals, or hazardous materials.

About Cygnus Professionals, Inc.

Cygnus is a Princeton, NJ-headquartered global Business IT consulting and software Services firm with offices in the USA and Asia. Cygnus offers and enables innovation and helps our clients accelerate time to market & grow their business. Over 15 years, we have taken great pride in continuing our deep relationships with our clients.

For further information about CYGNUS, please visit our website Title: Data Architect

Location: Princeton, New Jersey – Onsite

W2 Contract

Job Summary

We are seeking an experienced Data Architect to design, build, and maintain scalable data architecture solutions supporting enterprise analytics, data integration, and digital transformation initiatives. The ideal candidate will work closely with business stakeholders, data engineers, and application teams to design robust data models, data pipelines, and enterprise data platforms that support advanced analytics and reporting.

Key Responsibilities

• Design and implement enterprise data architecture frameworks and best practices.
• Develop logical and physical data models for enterprise data platforms.
• Architect data lakes, data warehouses, and data integration solutions across cloud and on-prem environments.
• Collaborate with data engineers and application teams to build scalable data pipelines and ETL/ELT processes.
• Ensure data governance, data quality, security, and compliance standards are implemented across the data ecosystem.
• Evaluate and recommend data technologies, tools, and frameworks aligned with enterprise strategy.
• Provide architectural guidance for cloud-based data platforms (AWS/Azure/GCP).
• Optimize performance for large-scale data processing and analytics workloads.
• Support business intelligence, reporting, and advanced analytics initiatives.

Required Qualifications

• 10+ years of experience in data architecture, data engineering, or enterprise data management.
• Strong experience with data modeling (conceptual, logical, physical).
• Expertise with data warehouse and data lake architectures.
• Hands-on experience with ETL/ELT tools and data integration platforms.
• Experience with SQL and large-scale data platforms (Snowflake, Redshift, BigQuery, etc.).
• Experience working with cloud data platforms (AWS, Azure, or GCP).
• Strong understanding of data governance, data quality, and metadata management.
• Experience with big data technologies (Spark, Hadoop, Kafka) is a plus.

Preferred Skills

• Experience in Healthcare, Pharmaceutical, or Life Sciences domain.
• Knowledge of Master Data Management (MDM) and data catalog tools.
• Familiarity with BI tools such as Tableau, Power BI, or Looker.
• Strong communication skills to interact with business and technical teams.

Education

• Bachelor’s or Master’s degree in Computer Science, Information Systems, Data Science, or related field.

Cygnus Belief

We believe in our commitment to diversity & inclusion.

Equal Employment Opportunity Statement

Cygnus is an Equal Opportunity Employer. We ensure that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation.

All our employment decisions are taken without looking into age, race, creed, color, religion, sex, nationality, disability status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other aspects of employment protected by federal, state, or local law. Applicants for employment in the US must have work authorization.

Job Description for Project Management Associate - Fulltime and Onsite.

Project Management Associate is accountable for working projects by organizing meetings and coordinating follow-ups with internal and external project stakeholders across the globe. The projects would include R&D, site transfers, technology transfers, site transfers, and any source variation. Coordinate shipment of innovator samples. Perform business analysis and create term sheets as required. This individual will report into Sr. Director, Corporate Development.

Responsibilities:

Projects:

·      Drive 3rd party projects to completion

·      Support the India team for approvals and documentation required from Bion team

·      Organize meetings, publish meeting notes/action items, and follow-up on action items.

·      Understand and manage project schedules, and critical path activities

·      Follow up with vendors, and internal team on deliverables.

·      Update the project tracker on weekly basis.

·      Identify and inform the project issues to the project team and stakeholders, and work with the team to resolve issues

·      Conduct lessons learned sessions upon project completion.

RLD Shipments:

·      Identify RLD requirements, and create proforma invoices

·      Coordinate RLD sourcing and shipments

·      Track RLD shipments through delivery

Smartsheet:

·      Implement Smartsheet across all locations

·      Manage Smartsheet to generate weekly and monthly reports to track project progress

·      Identify areas to expand Smartsheet implementation

API Vendors:

·      Coordinate with Logistics/Vendors to ship and track project related shipments such as API, samples etc for key product launches

New Business Opportunities:

·      Create market share reports

·      Follow up on all licensing opportunities

·      Create and generate reports weekly, monthly, and ad-hoc.

·      Proficient in Microsoft Office Excel and Powe point applications

. Ability to build business case

Compliance:

·      Stay compliant with Site training requirements in SOPs and cGMPs

Qualifications:

·      Bachelor’s degree required, preferably in Engineering, Supply Chain or Operations

·       2 to 3 years of prior generics pharmaceutical project management and analysis experience

·      Ability to work with cross-functional teams and multiple site teams

·      Ability to work with collaborative project management tools

·      Preferred experience in Microsoft Office applications including Visio, MS Project

Additional Qualifications:

·      Problem solver, Go-getter, and ability to collaborate

·      Ability to act in an ethical, honest and professional manner at all times

·      Ability to speak and write English in a clear and understandable manner

·      Must have the ability to carry out instructions furnished in both oral and written form

Job Location: BionPharma, Inc. Princeton, New Jersey.

Junior Data Engineer

Location: East Windsor, New Jersey

E-Verified | Visa Sponsorship Available

About Us:

BeaconFire, based in Central NJ, is a fast-growing company specializing in Software Development, Web Development, and Business Intelligence. We're looking for self-motivated and strong communicators to join our team as a Junior Data Engineer!

If you're passionate about data and eager to learn, this is your opportunity to grow in a collaborative and innovative environment.

Qualifications We’re Looking For:

• Passion for data and a strong desire to learn and grow.
• Master’s Degree in Computer Science, Information Technology, Data Analytics, Data Science, or a related field.
• Intermediate Python skills (Experience with NumPy, Pandas, etc. is a plus!)
• Experience with relational databases like SQL Server, Oracle, or MySQL.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively within a team.

Your Responsibilities:

• Collaborate with analytics teams to deliver reliable, scalable data solutions.
• Design and implement ETL/ELT processes to meet business data demands.
• Perform data extraction, manipulation, and production from database tables.
• Build utilities, user-defined functions, and frameworks to optimize data flows.
• Create automated unit tests and participate in integration testing.
• Troubleshoot and resolve operational and performance-related issues.
• Work with architecture and engineering teams to implement high-quality solutions and follow best practices.

Why Join BeaconFire?

• E-Verified employer
• Work Visa Sponsorship Available
• Career growth in data engineering and BI
• Supportive and collaborative work culture
• Exposure to real-world, enterprise-level projects

Ready to launch your career in Data Engineering?

Apply now and let’s build something amazing together!

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Director, Quality Systems is a hands-on leadership role responsible for leading the development, design, and maintenance of the Quality Management System (QMS). This role will oversee the implementation and continuous improvement of the QMS to maximize efficiency, effectiveness, and compliance with all applicable GxP regulations and client requirements and expectations.

Key Responsibilities

• Develop and maintain the Site Quality Management System and provide ongoing assessment of QMS effectiveness through Quality Management Review (QMR) and other established monitoring programs and processes.

• Identify, execute, and manage quality improvement initiatives to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations and client requirements.

• Support the development of company objectives and ensure Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.

• Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics.

• Identify compliance gaps and improvement opportunities to inform the Site Quality Plan and inspection readiness strategies.

• Co-lead the Internal Audit program with the Head of Inspection Readiness, including oversight of audit schedules and ensuring appropriate follow-up in alignment with internal procedures, regulatory expectations, client requirements, and auditing best practices.

• Manage the CAPA system, ensuring root causes are clearly identified and addressed through robust corrective actions to prevent recurrence, and that actions are evaluated for effectiveness post-implementation.

• Establish and manage GMP training programs to ensure training requirements align with job functions and job descriptions.

• Collaborate with the Head of Inspection Readiness to coordinate activities related to regulatory and client inspections (announced or unannounced), including preparing documentation, identifying potential compliance gaps, and managing inspection logistics.

• Support post-inspection response activities, including drafting responses, coordinating updates, and ensuring follow-up actions are implemented within the QMS.

• Provide input into regulatory inspection responses to ensure systemic and comprehensive solutions address root causes and prevent recurrence.

Leadership & People Management

• Mentor and coach team members to continually develop and enhance their skills.

• Lead by demonstrating the company values of standing shoulder to shoulder, owning it always, breakthrough thinking, and competing where it counts.

• Foster a culture of accountability with progressive empowerment and ownership.

• Promote a culture that values innovation, continuous improvement, and personal accountability across the organization.

Required Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related scientific discipline.

• 10–12 years of cGMP or Quality experience, including prior supervisory or team leadership experience; or a Master’s degree with 5–7 years of relevant experience.

• Experience hosting and managing regulatory and client inspections.

• Strong understanding of Quality Systems requirements and regulatory expectations.

• Excellent oral and written communication, listening, and problem-solving skills.

• In-depth knowledge of regulated activities, health authority expectations, GxP, and Quality Risk Management.

• Strong organizational awareness with significant experience working cross-functionally.

• Experience developing and executing large-scale organizational change initiatives, including change management strategies and planning.

• Demonstrated ability to understand complex processes and facilitate teams toward effective solutions.

• Ability to design and implement global business processes and policies with a strategic and enterprise mindset.

• Proven experience influencing stakeholders across a broad spectrum of GxP topics.

• Flexibility to support varying work schedules, including evenings, weekends, or holidays as needed.

Preferred Qualifications

• In-depth knowledge of cGMP regulations and the ability to apply them in compliance with U.S., EU, and global regulatory standards.

• Experience with cell and gene therapy manufacturing in clinical or commercial environments.

• Strong track record managing quality systems and training programs.

• Expertise in aseptic manufacturing processes.

• Demonstrated ability to foster collaboration, influence cross-functional teams, and drive cultural and operational improvements.

• Innovative mindset with the ability to adapt best practices within a fast-paced, growing organization.

Required Degree

• B.S. in a relevant scientific discipline (advanced degree preferred).

Physical Requirements

Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for aseptic processing facilities, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals.

Title: Contracts Compliance Manager

Pay: $130,000 – $160,000 base + bonus potential

Location: Hamilton Township, NJ | Fully onsite with up to 25% travel (primarily to east coast HQ and field offices)

Company: Confidential manufacturing subsidiary of a publicly traded clean energy company

About the Role

A newly created, high-visibility opportunity for an experienced Contracts Compliance Manager to lead contract negotiation, administration, and compliance for both commercial and government sectors. This role supports a fast-growing manufacturing site and works cross-functionally with leadership, engineering, finance, and sales to manage contract risk, ensure FAR/DFARS compliance, and support real-time business decisions.

Responsibilities

Contract Management & Negotiation

• Draft, review, and negotiate a wide range of contracts (government, commercial, subcontracts, NDAs, POs, and MSAs).
• Oversee cradle-to-grave contract administration and ensure timely fulfillment of obligations.
• Lead contract negotiations with customers and vendors, balancing business goals with risk mitigation.
• Review RFPs/RFQs to ensure compliance and recommend appropriate risk management terms.

Compliance & Risk Oversight

• Ensure full compliance with FAR/DFARS and other government contracting requirements.
• Maintain alignment with public-company policies and standards.
• Partner with internal teams on audits, reporting, and documentation accuracy.
• Provide training and guidance to stakeholders on contract and compliance requirements.

Cross-Functional Collaboration

• Work closely with the General Manager, Engineering, Sales, and Finance teams.
• Support process improvements, revenue recognition, and operational efficiency initiatives.
• Serve as a subject matter expert on all contract compliance and policy interpretation.

Requirements

• Bachelor’s degree in Business, Legal Studies, Government Contracting, or related field (JD preferred).
• Minimum 5+ years managing both commercial and government contracts in manufacturing, defense, or industrial environments.
• Proven success in managing contracts cradle-to-grave and navigating FAR/DFARS.
• Product-based contract experience required (not software/IP).
• Strong drafting, negotiation, and analytical skills.
• Excellent communication and relationship management abilities.
• Experience with compliance initiatives or process improvement preferred.

Preferred Attributes

• Hands-on, adaptable team player with a proactive mindset.
• Strong business judgment and ability to work independently.
• Comfortable in a fast-paced, evolving environment.
• Sense of humor, accountability, and collaborative spirit highly valued.

Culture & Growth

• Tight-knit, collaborative team where everyone “rolls up their sleeves.”
• Exposure to senior leadership and opportunities to shape policies and processes.
• Onsite culture that values initiative, learning, and cross-functional visibility.
• Long-term stability with the backing of a publicly traded clean energy leader.

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.

The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.

Key Responsibilities

• Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.

• Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.

• Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.

• Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.

• Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.

• Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.

• Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.

• Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.

• Minimum 1 year of leadership, supervisory, or management experience (preferred).

• Prior experience in manufacturing, quality, or engineering is required.

• Excellent communication, leadership, and organizational skills.

• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

• Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.

Preferred Qualifications

• Experience with cell therapy automation technologies, closed-system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.

• Hands-on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.

Physical Requirements

• Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Regular, punctual attendance is required.

• Must be willing to be gown-qualified and work in CNC/ISO8/ISO7 cleanroom environments.

• Must be able to lift up to 25 lbs.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be able to sit or stand for extended periods.

• Must be willing to work with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Manufacturing Associate will support Cell Therapy Operations at our GMP-compliant facility, playing a critical role in the production of cutting-edge cell therapies. This position is ideal for a detail-oriented professional with strong aseptic technique and a proven ability to quickly master complex processes in a cleanroom environment. The successful candidate will demonstrate a deep commitment to current Good Manufacturing Practices (cGMP) and thrive in a collaborative, quality-driven setting. This role requires precision, adaptability, and a strong quality mindset to ensure the consistent delivery of high-standard therapeutic products.

Key Responsibilities

• Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring compliance with all cGMP and safety standards.

• Execute complex procedures for cell therapy manufacturing and sterile product operations—including cell culture, formulation, and cryopreservation—while maintaining strict adherence to written procedures, batch records, and cGMP regulations.

• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and functionality.

• Monitor and document all production processes with precision, ensuring traceability and compliance with regulatory standards.

• Identify and escalate deviations or non-conformances; participate in root cause analyses and implement corrective actions.

• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to support continuous improvement initiatives.

• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and sterilization activities.

• Maintain an organized, compliant workspace by following 5S principles and minimizing contamination risks.

• Participate in training sessions to stay current with manufacturing techniques, quality standards, and safety protocols.

• Support process development activities during technology transfer.

• Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods.

• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).

• Review MBRs daily to ensure documentation is accurate and complete.

• Participate in audits, inspections, qualifications, and validation activities.

• Handle chemicals such as corrosives, solvents, and biohazardous materials safely.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Biology, Biotechnology, or a related field preferred; equivalent experience will be considered.

• 1–3 years of experience in GMP manufacturing, preferably in cell therapy, biologics, or pharmaceutical CDMO operations.

• Strong knowledge of aseptic techniques and cleanroom protocols.

• Proficiency in basic mathematical concepts, including scientific notation.

• Proven ability to learn and master complex processes quickly.

• Exceptional attention to detail with a strong commitment to quality standards.

• Excellent collaboration, communication, and interpersonal skills.

• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.

Preferred Qualifications

• Experience in aseptic cell culture processing in ISO 5 biosafety cabinets, using universal precautions for handling human-derived materials.

• Familiarity with cell therapy automation technologies, closed system culture vessels, cell washers, and cell separation technologies for autologous or allogeneic product manipulation.

• Experience handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells.

• Proficiency in basic computer applications (e.g., Microsoft Office, electronic batch record systems).

Physical Requirements

• Ability to stand for extended periods and perform repetitive tasks in a cleanroom environment.

• Must be able to lift up to 25 lbs. and work in full cleanroom gowning and PPE for extended durations.

• Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be comfortable working with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available for shift work, including off-shift hours, weekends, and holidays, as needed to meet production demands. Flexibility to accommodate changing production schedules is required.