Specialist, Environmental Health and Safety

Made Scientific; Princeton (NJ); Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

Made Scientific, Inc. is seeking an Environmental Health & Safety (EHS) Specialist for our GMP cell therapy facility. This onsite role focuses on maintaining regulatory compliance, biosafety, hazardous materials handling and emergency preparedness across labs, manufacturing, and warehouse environments.

The role partners with cross-functional teams to promote a culture of safety, perform risk assessments, inspections, and CAPA activities, and support audits and regulatory documentation.

Qualifikationen

• 3–5 years of EHS experience in biotechnology, pharmaceutical, cell or gene therapy, or other regulated environments.
• Experience supporting BSL-2 laboratories and biosafety programs.
• Knowledge of OSHA, EPA, DOT and biosafety regulations; hazardous waste management.

Aufgaben

• Support implementation and continuous improvement of EHS programs, policies and procedures.
• Ensure compliance with OSHA, EPA, DOT, CDC/NIH Biosafety and applicable regulatory requirements.
• Conduct inspections, audits, risk assessments and incident investigations.
• Coordinate hazardous, biological, pharmaceutical, and universal waste disposal and tracking.

Kenntnisse

Analytical

Organizational

Communication

Independent & Teamwork

Ausbildung

Bachelor's degree in Environmental Health & Safety or related field

Jobbeschreibung

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, testing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, we combine deep scientific expertise with agile, client-focused execution to deliver reliable and scalable manufacturing solutions. Backed by GC Corporation, a global leader in the pharmaceutical and biotechnology industries, Made Scientific is committed to advancing innovative therapies that improve patient lives.

We are seeking a Environmental Health & Safety (EHS) Specialist to join our team. This is a full-time, onsite position based in East Norritown, PA.

Position Summary

The Environmental Health & Safety (EHS) Specialist supports environmental, health, and safety programs in a GMP-regulated cell therapy manufacturing environment. This role ensures compliance with federal, state, and local regulations while promoting a culture of safety across laboratory, manufacturing, warehouse, and office operations. The Specialist partners with cross-functional teams to manage biosafety, hazardous materials, emergency preparedness, occupational safety, and environmental compliance.

Key Responsibilities

• Support implementation and continuous improvement of EHS programs, policies, and procedures.
• Ensure compliance with OSHA, EPA, DOT, CDC/NIH Biosafety, and applicable regulatory requirements.
• Conduct inspections, audits, risk assessments, and incident investigations.
• Monitor EHS metrics and recommend corrective and preventive actions.

Biosafety & Laboratory Safety

• Support biosafety programs for BSL-2 laboratories and manufacturing operations.
• Perform biological risk assessments and ensure proper use of containment equipment and PPE.
• Assist with biological spill response and exposure investigations.

Hazardous Materials & Waste

• Manage chemical inventory and Safety Data Sheets (SDS).
• Coordinate hazardous, biological, pharmaceutical, and universal waste disposal.
• Ensure regulatory compliance for hazardous waste storage and transportation.

Training & Employee Engagement

• Deliver EHS training for new hires and employees.
• Promote employee awareness through safety committees, training, and engagement initiatives.
• Serve as a resource for EHS-related questions.

Emergency Preparedness & Compliance

• Support emergency response planning, drills, and incident response.
• Maintain required permits, records, and regulatory documentation.
• Assist with regulatory inspections, customer audits, CAPA activities, and environmental reporting.

Cross-Functional Support

• Partner with Manufacturing, Facilities, Engineering, Quality, and Supply Chain to support safe operations.
• Participate in change control, facility modifications, qualification, validation, and continuous improvement projects.

Required Qualifications

• Bachelor's degree in Environmental Health & Safety, Occupational Safety, Industrial Hygiene, Environmental Science, Biology, Engineering, or related scientific field.
• 3–5 years of EHS experience in biotechnology, pharmaceutical, cell or gene therapy, biologics manufacturing, healthcare, or another regulated environment.
• Experience supporting BSL-2 laboratories required.
• Experience with incident investigations, risk assessments, and regulatory compliance.
• Knowledge of OSHA, EPA, DOT, and biosafety regulations.
• Understanding of hazardous waste management and chemical hygiene.
• Strong analytical, organizational, and communication skills.
• Ability to work independently and collaboratively in a fast-paced GMP environment.

Preferred Qualifications

• Professional certification (ASP, CSP, CIH, CHMM, CBSP, or similar).
• Experience with cell and gene therapy, viral vectors, or biologics manufacturing.
• Experience with EHS management systems and industrial hygiene programs.

Physical Requirements

• Ability to work in laboratory, manufacturing, warehouse, and office environments.
• Wear required PPE and lift up to 25 pounds occasionally.
• Stand, walk, bend, and climb stairs as needed.

Work Environment

GMP manufacturing facility with BSL-2 laboratory operations. Occasional after-hours support may be required for audits, emergencies, or critical operational activities.

Equal Employment Opportunity Statement

Made Scientific is proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We make employment decisions based on qualifications, merit, business needs, and job requirements without regard to race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship status, or any other status protected by applicable federal, state, or local law.

Made Scientific is committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, unless doing so would create an undue hardship.