Biospecimen Specialist II

Werfen - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States Country United States Shift 1st About the Position Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary Laboratory-focused role combining technical experience with project coordination skills. Coordinates collection, testing, and storage of biospecimens and their associated data for designated projects within the Biobanking group that support Biobanking operations, quality, and compliance. May support product development efforts of diagnostic instruments and reagents. Responsibilities Key Accountabilities Together with management, develops, implements, and monitors standard operating procedures (SOP) in the Biobanking Laboratory. Responsible for developing protocols for handling, testing, and creation of Biobank specimens in accordance with good laboratory practices (GLP) and proper scientific methods. Organizes and communicates with phlebotomists to collect, process and test human plasmas according to design specifications. Creates schedule for testing and characterization of blood samples in response to stakeholder needs in collaboration with biospecimen specialist(s) Responsible for regular review of sample and reagent quality and inventory; communicates inventory status and characterization to management. Provides recommended solutions where possible. May be responsible for long‑term planning projects, requiring sample and reagent management design and execution. For assigned projects, responsible for maintaining specimen clinical and laboratory data in biobank database to facilitate proper categorization of samples with critical focus on data entry, data oversight, and data reconciliation. Collaborates with statisticians and scientists for data processing and data analysis activities to ensure quality standards are met. Delivers and communicates assigned project results in a succinct and timely manner to team members and cross‑functionally, as needed; together with management, prepares technical documentation and reports as required. Coordinate with key vendors, internal supplier(s), to facilitate core lab functions / requirements (instrument maintenance). Other duties and/or projects as assigned. Networking/Key relationships R&D (Coagulation Analytical & Critical Care Teams). Biobanking and/or Phlebotomists at other Werfen Technology Centers. External Vendors – Commercial / Internal Suppliers. Qualifications Minimum Knowledge & Experience for the position: Bachelor’s degree in biology, biochemistry, chemistry or related scientific discipline or Medical Laboratory Science required. Minimum of 3 years’ experience in a clinical or research laboratory required; preferably in biospecimen handling and operational experience. Working knowledge in specimen handling and laboratory techniques required. Experience with Laboratory Information Management Systems (LIMS) and regulatory standards such as HIPAA required. Minimum of 3 years’ experience working with project management and database management tools, strongly preferred. Technical knowledge of automated clinical systems and assays preferred. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Strong written and verbal communications skills Strong computer skills utilizing word processing, spreadsheets, databases, and email software. Proven experience providing excellent customer service to stakeholders and research collaborators. Ability to work independently, managing multiple priorities and/or project streams. Critical attention to detail. Strong organizational and time management skills; ability to handle complex procedures in tandem with project workload. Ability to apply critical thinking and problem‑solving skills independently. Up to 5% of the time. Occasional travel to other Werfen sites may be required. The annual salary range Werfen reasonably expects to pay for the position is $70,000 to $100,000. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. 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