B.S. or M.S. in Biology or related field with relevant industry experience.
Prior laboratory supervisory or team lead experience.
Proficient in multi-color flow cytometry, ELISA, MSD, Luminex, qPCR, and ddPCR.
Experience in developing and optimizing cell-based potency assays.
Strong troubleshooting skills for complex biology assays.
Ability to work independently and manage multiple tasks effectively.
Excellent attention to detail and organizational skills.
Responsibilities
Develop and optimize analytical methods, focusing on potency assays and advanced characterization methods.
Design and execute experiments to enhance assay performance and readiness.
Prepare technical documentation for method transfer and support partner training.
Generate and present scientific data to stakeholders for product characterization and regulatory submissions.
Author technical reports and serve as a resource for potency assay activities.
Lead and develop a team of process development scientists.
Foster collaboration and morale within the team.
Benefits
Comprehensive medical coverage, dental, and vision options.
Life and disability insurance.
401(k) with company match.
Paid vacation and holidays.
Eligibility for yearly goal-based bonus and merit-based increases.
Full Job Description
Job Description
Position Overview:
Our Eurofins PSS team is seeking an Analytical Development Scientist Group Leader to work onsite supporting our client's analytical development activities across product characterization, process development, and analytical method execution for lentiviral vector (LVV)-based gene therapy products. The successful candidate will focus on potency assay development, optimization, and method transfer activities while partnering with internal and external laboratories to establish robust, phase-appropriate analytical methods. This role is an excellent opportunity for a detail-oriented scientist to generate analytical data supporting product understanding, process changes, and advancement toward clinical development.
Technical Responsibilities:
Develop, optimize, and qualify analytical methods with primary emphasis on potency assays, cell-based assays, and advanced characterization methods.
Support design and execution of experiments to improve assay performance, establish method readiness, and support analytical control strategy development.
Support analytical method transfer activities by preparing technical documentation, supporting partner training, reviewing transferred data, and troubleshooting assay performance.
Generate, analyze, and present scientific data to cross-functional stakeholders to support product characterization, process changes, comparability assessments, and regulatory submissions.
Contribute to authoring technical reports, protocols, method transfer packages, and analytical development documentation while serving as a technical resource for potency assay and analytical development activities.
Leadership & Team Management Responsibilities:
Lead, manage, and develop a team of process development scientists.
Serve as a proactive and effective point of contact for client and internal teams.
Participate in new hire interviews and onboarding processes.
Disseminate administrative communications and promote company vision.
Ensure adherence to highest quality and efficiency standards in laboratory operations.
Perform administrative tasks to support team member growth and development.
Balance technical work with team leadership responsibilities.
Foster morale, collaboration, and teamwork with the group.
Qualifications
Basic Minimum Qualification:
B.S. in Biology, Biochemistry, Cell Biology, Molecular Biology or a related field with 3+ years of relevant industry experience. OR M.S. in Biology, Biochemistry, Cell Biology, Molecular Biology or a related field with 1+ years of relevant industry experience.
Prior laboratory supervisory or team lead experience.
Proficient in multi-color flow cytometry (3-4 color panels), ELISA, MSD, Luminex, qPCR, ddPCR, and other characterization platforms.
Previous experience supporting the development and optimization of cell-based potency assays.
Ability to troubleshoot and interpret experimental results from complex biology assays, identify sources of analytical variability, and present conclusions
Ability to work independently with minimal supervision after initial training.
Ability to set priorities and multi-task activities to effectively manage workflows and drive deliverables to completion.
Significant attention to detail and accuracy in following, executing, and documenting experimental protocols and results in electronic notebooks.
Strong team orientation, with excellent organizational skills, self-motivation, and a positive attitude.
Strong communication skills, with the ability to clearly communicate experimental results and observations.
Authorization to work in the United States indefinitely without restriction or sponsorship.
Preferred Qualifications:
Experience with viral vector, cell therapy, gene therapy, or related biologics products.
Experience viral vector characterization, transduction assays, or potency-related analytical methods.
Experience with assay qualification, validation, comparability, and lifecycle management.
Experience in analytical method transfer to external laboratories, CDMOs, CROs, or QC organizations.
Familiarity with automation platforms, liquid handlers, or high-throughput analytical workflows.
Familiarity with regulatory expectations and analytical documentation supporting IND, IMPD, or BLA submissions.
Additional Information
This role is a full-time, permanent position Monday-Friday 8am-5pm. Candidates currently located within commutable distance to Boston, MA are encouraged to apply.
Excellent full-time benefits include:
Comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eligibility for yearly goal-based bonus & merit-based increases
Compensation: $38.00-$46.00 per hour based on education and relatable industry and leadership experience.
About Eurofins Lancaster Laboratories
Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
