CMO Analytical Support Coordinator

Company Description Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries.

The Group believes it is the world leader in food, environment and pharmaceutical 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, advanced material sciences and for supporting clinical studies.

In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.

Group’s key figures (as of March 2019) are approx.

3.8 billion Euros turnover, over 800 laboratories across 47 countries and about 45,000 staff.

Job Description Analytical Development and Outsourcing Scientist responsibilities include, but are not limited to, the following: Collaborating with commercial manufacturing teams to support facility start-up activities and provide analytical support both within the client network and at contract manufacturing organizations (CMOs) or contract testing laboratories.

Support various vaccine and biologics registrations, launches, and troubleshooting activities external to the US, including documentation preparation and coordinate supply of critical reagent shipments.

Authoring and/or reviewing technical documents to support method transfer, Process Performance Qualification (PPQ) and licensure.

Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.

Participate in analytical quality risk assessments.

Support for global filings, including author and review license applications.

Vaccine/Biologics Assay Life Cycle activities across various vaccine/biologics franchises and Manage global registration and test on importation (TOI) activities.

Manage internal and global analytical method transfer activities analytical platforms.

Qualifications The ideal candidate would possess: A minimum of 2 years of experience working in a GMP laboratory environment.

Detailed oriented and good project management skills.

Ability to work independently and within a cross-functional team.

Analytical or Project Lead experience managing method validation or method transfer.

Ability to learn new techniques and multi-task is critical to this position.

Experience with HPLC, ELISA, and/or Capillary Electrophoresis (CE) is a plus.

Good technical, communication (oral and written), interpersonal, and teamwork skills.

Self-motivated with a positive attitude and proven performance record.

Method development and validation experience.

Method transfer experience with an external contract laboratory or global sites preferred.

Project Management Professional certification.

Global supply or launch experience.

Authoring and/or reviewing technical documents to support method transfer and Process Performance Qualification (PPQ) Basic Minimum Qualifications: A Bachelor’s Degreein Biology, Chemistry, Biochemistry or related sciences with a minimum of two (2) years of industrial experience OR aMaster’s Degree.

Additional Information Position is full-time, Monday
– Friday, 8:00am-4:30pm with overtime as needed.Candidates currently living in a commutable distance to West Point, PAare encouraged to apply.

What we Offer: 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 aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.