Biological Critical Reagent (BCR) Specialist

Eurofins PSS Insourcing Solutions; West Point (PA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Bonus potential

Job summary

Eurofins PSS Insourcing Solutions seeks a reagent lifecycle specialist to manage critical materials used in vaccine and biologics testing. You will oversee acquisition, qualification, storage and replacement, while ensuring GMP/GLP compliance and accurate documentation.

The role requires collaborative communication with global stakeholders, strong data analysis, and the ability to manage multiple priorities in a regulated lab environment. West Point, PA area; Monday–Friday, 8am–5pm.

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry or related field.
• Minimum 2 years of laboratory experience in biochemistry, cell biology, biologics or vaccine testing.
• GMP/GLP knowledge and documentation experience.
• Strong communication and documentation skills.

Responsibilities

• Manages lifecycle of reagents (reference standards, controls, antibodies) for release and stability testing.
• Applies GMP/GLP and maintains inventory and lifecycle records.
• Coordinates testing, qualification, storage and replacement of reagents.
• Performs data analysis and supports regulatory submissions and inspections.

Skills

Communication

Documentation

Attention to detail

Independent work

Multitasking

Collaboration

Computer skills

Education

Bachelor's degree in Biology/Biochemistry

Job description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

Job Description

This position is responsible for managing the complete lifecycle of critical reagents (reference standards, positive controls, anti-sera, and other critical materials) used in the release and stability testing of vaccine and biological products. This includes but is not limited to acquisition, certification and qualification testing, implementation, and ongoing monitoring and replacement of the critical reagents as needed.

Essential Duties and Responsibilities

• Applies GMP/GLP in all areas of responsibility.
• Maintains critical reagent inventory and lifecycle documentation.
• Coordinates acquisition, qualification testing, implementation, storage, and replacement of critical reagents.
• Performs sample preparation, testing support, and routine data analysis associated with reagent qualification activities.
• Conducts second-person review of laboratory documentation and records.
• Documents work accurately and in accordance with regulatory requirements.
• Escalates quality events, deviations, and potential compliance concerns to leadership.
• Supports regulatory submissions and inspection readiness activities.
• Communicates effectively with internal and global stakeholders.
• Detects problems affecting work quality and brings them to management attention.
• Conducts all activities safely and efficiently.
• Performs other duties as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change at any time with or without notice.

Qualifications

Required Education, Experience, Skills and Certifications:

• Bachelor's degree in Biology, Chemistry, Biochemistry, or related scientific discipline.
• Minimum 2 years of laboratory experience in biochemistry, cell biology, biologics, or vaccine testing.
• General laboratory skills and scientific background knowledge.
• Experience with aseptic technique and GMP documentation.
• Strong computer, organization, and documentation skills.
• Excellent communication, collaboration, and attention to detail.
• Ability to work independently and manage multiple priorities simultaneously.
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

This role is a full-time, permanent position Monday-Friday 8am-5pm. Candidates currently located within commutable distance to West Point, PA are encouraged to apply.

Excellent full-time benefits include:

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for yearly goal-based bonus & merit-based increases

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.