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Development Specialist II - Team Leader

Eurofins

Development Specialist II - Team Leader

Lexington, MA
Full Time
Paid
  • Responsibilities

    Job Description

    • Lead a team of scientists towards the execution of analytical methods to support the biological therapeutic product release and characterization testing in a compliance-based environment
    • Contributes as part of a team of AD scientists towards execution and development of various analytical methods to support of biological therapeutic product release and characterization testing in a compliance-based environment.
    • Independently performs routine testing using established Test Methods, including associated protocol/report documentation and presentations.
    • 2-5 years industry experience with separation based HPLC/UPLC and CE methods and demonstrated experience working with Empower or Chromeleon software. Preferably experience of working one or more of the following methods: SEC, RP-HPLC, peptide map and glycan map.
    • Background in qualification and validation activities for regulatory support a plus.
    • Demonstrated hands-on trouble-shooting capabilities using HPLC and UPLC systems a must.
    • Independently executes method for quantitation of process- and product-related impurities.
    • Computer competency is essential with emphasis on spreadsheet-based software
    • Understands and applies advanced scientific principles, theories, concepts, practices and standards for product development.
    • Conducts work in compliance with cGMP/GLP, safety and regulatory requirements.
    • Demonstrates independent judgment in technique and method selection, protocol and study design and execution, data analysis and use of standard practices and procedures for a variety of problems of moderate scope and complexity to meet assigned objectives.
    • Lead team and ensure adherence to highest quality and efficiency standards in laboratory operations.
    • Ensure coverage to deliver results in a timely manner
    • Foster morale and teamwork
    • Be a cheerleader for your team
    • Mentor, motivate, and inspire staff toward strong technical performance.
    • Foster better communication between team and client
    • Follow guidance from manager or director (as applicable)
    • Assist in hiring and onboarding as well as performance evaluations
  • Qualifications

    Qualifications

    • BS and MS in Cell and Molecular Biology, Biochemistry, Pharmaceutical or related discipline
    • Minimum of 2-5 years of relevant industry experience
    • Experience with HPLC/UPLC required
    • Technical expertise in one or more bioanalytical and bioassay technologies, including experience with separation using HPLC/UPLC, CE methods and demonstrated experience of working with Empower and Chromeleon software.
    • Knowledge of theories, principles and techniques of relevant scientific areas and basic understanding of industry practices and standards.
    • Prior leadership experience is a plus
    • Strong computer, scientific, and organizational skills.
    • Excellent communication (oral and written) and attention to detail.
    • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
    • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
    • Authorization to work in the United States indefinitely without restriction or sponsorship

    Additional Information

    Position is full-time, Mon-Fri 8:00am-5:00pm.  Candidates currently living within a commutable distance of Lexington, MA 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.

  • Industry
    Financial Services