Principal Scientist, Biologics Pipeline Development (Biomarkers)
Company: The U.S. Pharmacopeial Convention (USP)
Location: Rockville
Posted on: January 19, 2023
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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
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