Head of Biomarker Services

2 weeks ago


Exton, Pennsylvania, United States Frontage Laboratories Full time
Job Overview

Position: Biomarker Services Director

Employment Type: Full-time

Location: On-site

Role Summary:

The Biomarker Services Director is integral to advancing scientific projects, collaborating with the operations team to implement various methodologies and ensure the successful execution of initiatives. This role also emphasizes the professional development of scientific personnel through mentorship, guidance, and training. As the Subject Matter Expert (SME) in biomarkers, the Director is crucial in all interactions with external stakeholders, significantly influencing Frontage's Global Biomarker Service Strategies. This encompasses showcasing Frontage's biomarker capabilities, engaging with biopharma sponsors to comprehend their bioanalytical requirements, and assisting the Frontage business development team by evaluating proposals, RFIs, RFPs, SOWs, and final agreements.

KEY RESPONSIBILITIES:

  • Lead Biomarker Initiatives: Provide strategic and scientific direction to enhance the biomarker services within the department.
  • Client and Operations Support: Address client inquiries specifically related to biomarker services by participating in discussions, calculating costs, and delivering pertinent information promptly.
  • Daily Operations Assistance: Support clients and operational staff in creating scientifically valid and regulatory compliant solutions for study design, execution, and evaluation, including managing deviations and unexpected outcomes.
  • Showcase Frontage's Biomarker Capabilities: Present the strengths and capacities of Frontage's biomarker services to potential clients.
  • Quality Assurance Participation: Engage in and prepare responses for both internal and external technical and quality assurance evaluations as necessary.
  • Industry Involvement: Participate in industry technical and trade organizations to enhance the company's reputation as a leader, generate new business opportunities, and deepen market understanding.
  • Stay Informed on Industry Trends: Keep abreast of relevant scientific advancements and regulatory changes in the biomarker field, providing insights to senior management for strategic planning.
  • Knowledge Dissemination: Identify topics (both technical and service-oriented) for potential publication or presentation that highlight Frontage's expertise in biomarkers.
  • Strategic Development: Assist in formulating short-term and long-term operational goals, organizational structure, staffing needs, and succession plans specific to biomarker services.
  • Continuous Process Improvement: Promote and support ongoing enhancements of processes within the Biomarker department, focusing on service delivery.
  • Additional Duties: Perform other responsibilities as assigned.

MINIMUM REQUIREMENTS:

  • PhD or equivalent in biological sciences or related disciplines.
  • 10+ years of experience in the biotechnology or pharmaceutical sector, with a robust background in biopharmaceutical testing methods such as Simoa, ELLA, MSD, and ELISA.
  • Experience in a GLP environment is essential.
  • CRO experience is preferred but not mandatory.
  • An equivalent combination of education and experience may be considered as a satisfactory substitute for the specific qualifications listed above.
  • Exceptional management and communication skills with the ability to lead a multidisciplinary team.
  • Comprehensive understanding of GLP, FDA Guidance, or CLIA regulations.
  • Strong communication skills and a client-focused approach.
  • Willingness to travel domestically and internationally as required.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.



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