Associate Director, Product Development

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 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

Essential Duties and Responsibilities:

• Responsible for managing the development and launch of a new portfolio of TR-FRET immuno-assays following a phased stage-gate launch process.
• Works closely with marketing team to define scope of portfolio offering, product release specifications, data package requirements, and product release schedule.
• Oversees development, troubleshooting, and validation of new TR-FRET assays for detection of specific analytes in cell culture medium, cell lysates, blood, etc. Works diligently to meet product development goals set by management team
• Oversees assay validation exercises to determine LLOQ, LLOD, Z’, spike recovery, etc., as well as appropriate benchmarking exercises against competitor products to generate data to support marketing activities.
• Ensures appropriate documentation of assay development history, generates SOPs for kit component manufacturing and detailed protocols for user manuals.
• Works closely with manufacturing team to identify and qualify appropriate vendors for critical kit components and trains internal manufacturing and QC teams to support kit assembly and component QC.
• Works closely with Marketing team to provide validation data in formats suitable for inclusion in marketing materials, scientific presentations (posters, webinars, white papers, etc.) and user manuals to support product launch
• Demonstrates and promotes the company vision
• Regular attendance and punctuality
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned
• Owns accountability and responsibility of delivering to client needs and timelines
• Provides cross-functional support to other departments as required
• Adjusts work hours as needed to meet client deadlines
• Adheres to all site employee health and safety (EHS) and IT security requirements

Qualifications

• MS/PhD or equivalent experience in cell biology, biochemistry or related discipline, with a minimum of 7 years of industrial experience in assay and product development

• Experience mentoring and supervising technical staff is required.

• Demonstrated knowledge developing immuno-assays with TR-FRET, ELISA, or similar assay format
• Experience overseeing product development, preferably for a large portfolio of similar assays, using a phased stage gate process strongly preferred
• Experience drafting qualification / validation reports and SOPs for assay transfer to clients or other departments strongly preferred
• Excellent verbal, written communication and presentation skills are essential
• The successful candidate must be a highly motivated individual with a positive attitude who is comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines
• Ability to independently learn new techniques, solve practical problems and troubleshoot assays
• Must be team-oriented with a demonstrated track record working in a collaborative environment
• Experience in GMP/GLP or ISO environment preferred.
• Experience dealing d