Job description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
ICON Government and Public Health Solutions (IGP) is a full-service CRO specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.
IGP is currently seeking a Bioanalytical Development SME to support the Biomedical Advanced Research and Development Authority (BARDA).
Responsibilities Duties include, but not limited to:
- Support BARDA Program Office(s) as a subject matter expert in relevant field of experience(s) for vaccine, therapeutic, and/or antimicrobial advanced development; clinical and/or regulatory policy; and/or manufacturing capacity construction.
- Provide guidance documents and option papers on key issues related to the area(s) identified;
- Review contract proposal and related documents;
- Provide senior-level briefing(s) to ASPR/BARDA as required;
- Prepare regular reports to ASPR/BARDA management on various technical issues identified.
- Provide project development level portfolio management and oversight;
- Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts;
- Evaluate contractor's risk management programs in the areas of analytical development associated with nonclinical studies, upstream and downstream manufacturing and/or biopharmaceutical product delivery method. Assist in the modification of development programs and projects as needed to decrease development risk.
- Review the CMC aspects of biopharmaceutical product development plans/proposals for feasibility, assist in the rating and selection of projects against government needs, and assist in the post award monitoring of project execution against set plans and schedules.
- Perform site visits/audits with the government's Contracting Officer (CO) at contractor's facilities, and/or facilities of subcontractors.
- Identify and support the development of bioanalytical approaches required to accelerate the development and availability of vaccines or other biopharmaceutical products.
- Work as part of an interdisciplinary team to assist BARDA contract partners to develop effective technologies and products with valid, high-yielding and economical processes for production.
- Act as analytical development Subject Matter Expert to inform and mentor colleagues.
- Assist in the rating and selection of projects against government needs, and assist in the post award monitoring of project execution against set plans and schedules.
- Review and advise on the development of stability programs and analysis of stability data.
- Assess design and operation of quality laboratory facilities for compliance with cGMPs/GLPs.
- Monitor compliance with relevant non-clinical contract requirements, federal regulations, and FDA and ICH CMC guidelines.
- Inform CO of increase/decrease in risk to successful project completion.
- Generate contingency risk reduction plans.
- Prepare draft Statement of Work (SOW) for upcoming Requests for Proposals (RFP) and assist offerors in the development of proposed project SOWs.
- Review reports, SOPs and protocols and provide advice on the development and validation of analytical procedures of all kinds. Assays of interest include nucleic acid content and purity, lipid identification and content, encapsulation, particle size and dispersity, protein expression, ELISA, ELLA, IDMS, SPR.
- Assess aspects of analytical development plans and proposals for feasibility.
- Support qualification, validation, comparability, and transfer of test methods.
Preferred Required Qualifications:
- Education: Ph.D. in Biochemistry, Pharmaceutical Sciences, Biochemical Engineering, Virology or equivalent Life Sciences discipline
Skills:
- Experience with non-clinical product development strategy, design and results interpretation to support product development towards regulatory approval by both traditional and alternative licensure pathways.
- Bioanalytical development, qualification and validation to support product development and regulatory approval with emphasis on potency and novel product characterization assays.
- Experience in assay technology transfer between development and manufacturing operations and/or between facilities or external partners/collaborators.
- Experience developing and implementing methods relevant to material properties, formulation, pharmaceutical unit operations, product stability, route of delivery, and/or in vivo performance. o Knowledge of new bioanalytical technologies.
- Experience in transitioning vaccines and/or other biopharmaceutical products through the stages of development towards licensure (i.e. pre-clinical development to commercial launch).
- Analytical test development for evaluation of product characteristics such as concentration, potency or activity evaluation of in-process, drug substance and drug product samples.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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