Bioassay Method Development

Eurofins PSS Insourcing Solutions; Malvern (Chester County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

Disability Insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins Scientific in Malvern, PA is seeking a full-time scientist to perform testing in support of analytical development and manufacturing processes. You will record data meticulously in GMP-compliant notebooks, troubleshoot assays, and report results with clients as needed.

The role requires aseptic technique and experience with various analytical methods in a GMP environment. The position emphasizes collaboration with QC labs, regulatory support for INDs/BLAs, and maintaining strict data

Qualifications

• Bachelor’s degree in chemistry, biology, or a related life sciences field.
• Strong organization, time-management, and communication skills.
• Solid knowledge of cGMP guidelines, GDP (good documentation practices), and aseptic technique.

Responsibilities

• Perform testing to support analytical development, manufacturing process development, and process validations.
• Accurately record data in a timely manner, maintaining detailed records in compliance with GMP, safety, and environmental requirements.
• Troubleshoot experiments, analyze data, interpret results, and report findings in lab notebooks; collaborate with clients to troubleshoot assays.
• Support regulatory filings, including INDs and BLAs.
• Provide technical support (ELISA, FRETS, cell-based assays, flow cytometry, PCR, gel electrophoresis, Western blot) with development and QC labs.
• Handle and maintain cell lines following aseptic techniques in GMP labs.

Skills

Organizational skills

Time management

Communication skills

Education

Bachelor's degree in chemistry, biology, or related life sciences

Job description

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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in‑vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

• Perform testing to support analytical development, manufacturing process development, process validations.
• Accurately record data in a timely manner, including maintenance of detailed records in compliance with applicable Good Manufacturing Practice (GMP), safety, and environmental requirements. Ensure data integrity and protocol compliance.
• Troubleshoot, and execute experiments independently. Analyze data, interpret results, and report data in laboratory notebooks. Collaborate with client to troubleshoot assay problems as they occur.
• Support regulatory filings, including INDs and BLAs.
• Provide technical support (ELISA, FRETS, Cell based assays, Flow cytometry, PCR, gel electrophoresis, and Western blot techniques & other techniques) with development and QC laboratories and support Quality Assurance.
• Ability to handle and maintain various cell lines following aseptic techniques in GMP labs.

Qualifications

• Bachelor’s degree in chemistry, biology, or a related life sciences
• Strong organization, time-management, and communication skills
• Strong knowledge or experience working within cGMP guidelines, GDP (good documentation practices), and aseptic technique

Additional Information

Position is full-time, Monday-Friday, 8 a.m. - 5 p.m, weekend work might be expected. Candidates currently living within a commutable distance of Malvern, PA.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays