QC bioassay Scientist Group Leader

We are currently seeking a qualified professional with substantial experience in analytical method development and technology transfer within a GMPregulated environment whose main job function will be to support our client with GMPrelated sample testing and method validation. The individual will also serve as a group leader overseeing a team of Eurofins PSS employees supporting the client.

Primary Responsibilities:

• Execution of complex GMP release and stability assays such as cellbased functional assays such as PCR ELISA and NGS assays.
• Technical transfer qualification and validation of bioassays used for lot release and characterization of cell and gene therapy products and critical materials.
• Author and review SOPs and technical reports.
• Work with crossfunctional groups within the client environment to participate in various aspects of method development transfer processs and product characterization comparability and investigations.
• Analyze track and trend data to monitor analytical assays and ensure consistency in assay performance.

Leadership Responsibilities:

• Supports and monitors the performance of the team of employees
• May participate in new hire interviews
• Supports the onboarding process of new employees
• Disseminate administrative communications
• Demonstrate and promote the companys vision
• Ensure adherence to highest quality and efficiency standards in laboratory operations 
• Ensure coverage and performance for all shifts and work duties 
• Performs administrative tasks for team member growth and development
• Adeptly balance technical lab work with leadership responsibilities
• Foster morale and teamwork 

Qualifications :

• Bachelors degree with 38 years of experience
• Masters degree with 25 years of experience
• Proficient experience in validating analytical methods in compliance with GMP standards.
• Handson experience with the successful transfer of methods into GMP laboratories.
• Handson experience with sample testing in a GMP laboratory.
• Solid understanding of regulatory expectations (e.g. FDA EMA) concerning method lifecycle management.
• Team player with excellent oral and written communication skills
• Independently motivated detailoriented and excellent problemsolving abilities.
• Laboratory supervisor experience is preferred
• Experience with potency assays (e.g. cellbased assays ELISA) is advantageous but not essential.
• LIMS experience is a plus

Additional Information :

The position is fulltime and permanent MondayFriday 8 am5 pm with overtime as needed. Candidates living near or in Cambridge MA are encouraged to apply.

Excellent fulltime benefits include:

• Comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global awardwinning insourcing solution that places our people at our clients sites dedicated to running and managing laboratory services while eliminating headcount coemployment and projectmanagement worries.

We infuse our 55year track record of scientific and laboratory operations expertise as well as HR and a great place to work best practices to recruit hire train and manage highly qualified scientists to perform laboratory services using our clients quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories please explore our website .

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

Remote Work :

No

Employment Type :

Fulltime