Company 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 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. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. In 2019, Eurofins generatedtotal revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
Lead and perform upstream process development for large molecule based products within the API-Large Molecule group in Malvern, PA.
Lead design and execution of the development studies to identify and determine process parameter ranges for cell culture process steps.
Take a lead role to transfer process from development to GMP clinical and commercial manufacturing.
Leading and participating in design of experiments
Executing the planned experiments
Optimizing cell culture process steps
Data analysis for early and late stage products.
Record and analyze experimental data, verify data integrity and accuracy, and report/summarize findings to the project team, and write technical documents all levels of the organization; identify, prevent, or correct any departures from the quality system
Perform both routine and non-routine work as specified by separate and applicable technical job description for individual
Develop and implement operational improvements
Supervise others in performing client's service requirements
Coach, train, and develop others within the group with respect to their personal development and effective implementation of operational
Applies GLP in all areas of responsibility, as appropriate
Applies the highest quality standard in all areas of responsibility
Demonstrates and promotes the company vision
Demonstrates strong client service skills, teamwork, and collaboration
Proactively plans and multitasks to maximize productivity
Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
Regular attendance and punctuality
Responsible for organizing records, capturing results into data sheets and contributing to technical reports in a team environment as well as contributing individually to meet project timeline and objectives.
Demonstrate clear and professional verbal and written communication
Conduct, analysis and reporting of data in accordance with requirements set forth by the department
Ensure maintenance of detailed documentation of assay development and qualification
Record experimental data and accurate and highly organized laboratory notebooks
Analyze and present data in professional format
Follow appropriate SOPs and all internal documentation requirements.
Bachelors or Master's degree in biopharmaceutical, biotechnology or pharmaceutical required.
Broad knowledge in upstream process development and hands-on experience is desired.
Experience with cGMP practices
Occasional weekend work might be required.
Additional Information Position is full-time, Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of Malvern, PA are encouraged to apply.
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
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.