Potency Assay Scientist Group Leader

This role is for an advanced personnel who has indepth knowledge of cell based and potency assays and are comfortable with troubleshooting. The Group Leaders main technical responsibility will be to serve as SME for mRNA and gRNA potency assays to support several client programs. 

Technical Responsibilities:

• Optimize technical transfer qualification and validation of potency assays used for lot release and characterization of cell and gene therapy products and critical materials.
• Acting as an SME resource for potency assays.
• Execution of complex GMP release and stability assays such as cellbased functional assays flow cytometry methods ddPCR ELISA and NGS assays.
• Author and review SOPs and technical reports.
• Work with crossfunctional groups within the client environment to participate in various aspects of method development transfer process 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 :

Minimum Qualifications:

• Bachelors degree with 38 years of experience
• Masters degree with 25 years of experience
• Must have experience with potency assay execution
• Must have previous experience working in a GMP laboratory
• Understanding of industry practices and standards is required
• Laboratory supervisory experience is preferred
• Team player with excellent oral and written communication skills
• Independently motivated detailoriented and excellent problemsolving abilities.

Differentiating qualifications:

• Strong background in cell culture and experience working with cell lines and primary human cells.
• Experience with functional or potency assay transfer and execution in a GMP laboratory.
• Broad experience with molecular biology cellular and immunoassay techniques including transfections/transductions ddPCR/qPCR flow cytometry ELISA and NGS.
• Experience using data analysis software including JMP
• Knowledge of ICH/USP guidelines.

Additional Information :

What to Expect in the Hiring Process: 

• 1015 Minute Phone Interview with Region Recruiter
• 4560 Minute Virtual Interview with Manager and/or Group Leader
• 60 Minute In Person Meeting 

Additional Details: 

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