Principal Scientist, Biologics Pipeline Development (Biomarkers)

Company: The U.S. Pharmacopeial Convention (USP)
Location: Rockville
Posted on: January 19, 2023

Job Description:

Principal Scientist, Biologics Pipeline Development (Biomarkers) Rockville , Maryland Apply Now Apply Now w/ LinkedIn The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that works in collaboration with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.Brief Job OverviewA comprehensive pipeline of next-generation, biological standards is crucial for the implementation of the biologic's strategy. USP is exploring opportunities to develop physical standards for key protein biomarkers used in drug development to support consistency across assay platforms and laboratories. The Principal Scientist in Biologics Pipeline Development is a hands-on non-supervisory role that will be responsible for reviewing current assays and standards for biomarkers, identifying, and evaluating opportunities for new physical standards for key biomarkers. This non-laboratory role includes collaborating with key stakeholders and thought leaders in the industry to identify and prioritize opportunities, designing feasibility and proof of concept studies, analyzing results, and collaborating closely with both internal and external partners throughout development.How will YOU create impact here at USP?[15%] Evaluates the current state of the art for protein biomarkers and analytical assays for various diseases and identifies opportunities for new protein-based biomarker standards. Prioritizes potential targets and identifies gaps.[15 %] Develops relationships with key stakeholders from academia and industry to engage in biomarker collaborations. Designs and leads all aspects of collaborative projects.[20 %] Plans and oversees in-house or outsourced laboratory work for feasibility and proof of concept studies. Evaluates and analyzes scientific reports and identifies next steps and key challenges.[20%] Collaborates with the biologics program unit team, including strategic marketing and business development teams, to acquire insights based on internal and external data on biomarker opportunities for further exploration. Communicates and maintains working collaborations with various USP departments.[10 %] Plans industry roundtables focused on gathering input from stakeholders.. Works with technical writers and marketing teams on delivery and posting of summaries and white papers as applicable.[10 %] Supports USP to build its external presence through engaging stakeholders and giving presentations at conferences and preparing technical notes and/or publications.[10 %] Stays informed on current trends and developments in related scientific fields, particularly in the area of biomarkers and biological drug targets.Who USP is Looking For?The successful candidate will have a clear understanding of our mission, dedication to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with team members, along with the following proficiencies and experience:Ph. D. degree in Biochemistry, Biology, or a related field and ten (10) years of significant experience in biomarkers.Experience in biomarker assays (e.g., immunoassays), discovery, validation and development of biomarkers, and use of biomarkers for drug development.Additional Desired PreferencesDesired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifiers for candidate consideration.Strong scientific, technical, and regulatory understanding of protein biomarkers.Knowledge of biomarker assays related to development of biopharmaceutical products.Experience in development and optimization of biomarker immunoassays, potency assays, binding assays, and protein characterization.Understanding of how biomarkers are identified and developed for various illnesses and their role in medicinal chemistry across various treatment modalities.Established research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make recommendations.Strong writing skills and experience drafting technical reports related to material characterization, assay qualification, and method development.Ability to establish and build links with individuals of varying backgrounds and learning styles.Excellent presentation and interpersonal skills (written and oral).Proven track record leading external laboratory projects including timelines and budgets.Ability to communicate technical information with non-technical or non-scientific staff, and to interact optimally with representatives from pharmaceutical companies, government, and academic institutions. Ability to persuade corporations to collaborate with USP on various projects.Able to perform in a fast-paced environment with changing target dates and priorities. Ability to lead and prioritize multiple, concurrent projects.Supervisory ResponsibilitiesNoneUSP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully present vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work-from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)Job Category Chemistry & Scientific Standards

Keywords: The U.S. Pharmacopeial Convention (USP), Rockville , Principal Scientist, Biologics Pipeline Development (Biomarkers), Other , Rockville, Maryland