Qureos Mentor

US Pharmacopeia

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 Description
 
 
 
 At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.
 
 
 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&mdash;an environment where every employee feels fully empowered and valued irrespective of, but not limited to, 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.
 
 
 
 Brief Job Overview
 
 
 
 
 This is a hands-on, non-supervisory, non-laboratory role that serves as the liaison between the biopharmaceutical industry, regulatory agencies, USP departments and USP Expert Committees. The Documentary Standard Sr. Scientist facilitates the development of USP standards used by the global pharmaceutical industry. In this role, the incumbent will provide expertise, leadership, and guidance to USP Expert Committees and Expert Panels in the areas of mAbs, therapeutic proteins, peptides, oligonucleotides, antibiotics, gene therapy and vaccines, by facilitating the exchange of highly technical information and working collaboratively to improve and promote public health.
 
 
 
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 Identifies opportunities for new standards and solutions to address analytical challenges associated with the next generation of biological medicines.Develops strategies and processes for the elaboration of a steady pipeline of standards to support the analytical evaluation of different classes of biotherapeutics.
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 Develops relationships with key stakeholders from academia, industry and regulatory communities to engage in collaborations in early pipeline development projects. Leads collaborations with academic and stakeholder groups.
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 Collaborates with the biologics program unit team to gather insights based on internal and external data and perform analyses to inform on opportunities for further exploration. Communicates and maintains working relationships with other USP departments, as applicable.
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 Plans and oversees necessary laboratory work for feasibility and proof of concept studies. Evaluates and analyzes scientific reports and identifies next steps and key challenges. Engages and builds relationships with internal and external laboratories to participate in round robin studies or in support of feasibility and proof of concept studies.
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 Partners with the standards production team leads for eventual handoff leading to planning and initiation of standards development projects.
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 Collaborates with internal groups to develop application notes, training materials, and online content to support standards.
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 Leads expert panels and industry working groups; recruits and engages with members, defines project scope, and designs and advances work with input from external stakeholders and USP departments.
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 Serves as representative of USP at professional scientific meetings organized by USP and other organizations. Gives public presentations on USP matters (as assigned).
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 Stays ahead of current trends and developments in related scientific fields, particularly in the area of monoclonal antibodies and/or therapeutic proteins.
 
 
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 Who is USP Looking For?
 
 
 
 The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
 
 
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 Ph. D. degree in Analytical Chemistry, Biochemistry, Biology, or a relevant field. A base of 7-10 years of relevant experience with bioanalytical development in the pharmaceutical industry.
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 MS. level candidates with minimum of 11-13 years of commensurate industrial experience.
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 Combination of fundamental work experience and education may be substituted
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 Experience in process development, analytical characterization, and chemistry and manufacturing control (CMC) for biotherapeutics.,Strong experience in the areas of characterization and analysis of biopharmaceuticals,
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 Experience in method development and characterization of biological products, impurities, and raw materials using a variety of physicochemical techniques and biological assays.
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 Experience in method development, qualification and/or validation, method transfer, and development of system suitability criteria.
 
 
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 Additional Desired Preferences
 
 
 
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 Knowledge of reference standards related to biopharmaceutical products/industry. Experience with reference materials manufacturing and development is a plus.
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 Knowledge of national and international regulatory filings approaches. Familiarity with regulatory guidance documents from WHO, FDA, ICH and other international organizations.
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 Demonstrated research, technical, and analytical skills, as well as the ability to take highly technical scientific information and make recommendations.
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 Strong writing skills and experience drafting technical reports related to material characterization, method development and reference standard evaluation.
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 Expertise in analytical methods applicable to biotherapeutics. Experience in analysis of proteins, peptides or oligonucleotides would be a plus. Experience in immunogenicity testing is also a plus.
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 Demonstrated stakeholder collaboration experience, with the ability to develop and manage internal and external relationships and contacts.
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 Ability to establish and nurture relationships with individuals of varying backgrounds and learning styles.
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 Excellent presentation and communication skills (written and oral).
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 Ability to communicate technical information with non-technical or non-scientific staff, and to interact effectively with representatives from pharmaceutical companies, government, and academic institutions.
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 Project Management skills. Must have ability to prioritize and manage multiple, concurrent projects with often long-life cycles.
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 Effective at operating independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
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 Able to perform in a fast-paced environment with changing deadlines and priorities. Ability to manage and prioritize multiple, concurrent projects.
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 Experience and knowledge of the USP-NF is preferred.
 
 
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 Supervisory Responsibilities
 
 
 
 None, this is an individual contributor role.
 
 
 
 Benefits
 
 
 
 USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
 
 
 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.
 
 
 
 Job Category
 
 Chemistry &amp; Scientific Standards
 
 
 
 Job Type
 
 Full-Time
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Senior Scientist I, Documentary Standards (Pipeline Biologics)

<div>
 
 Description
 
 
 
 At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.
 
 
 USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds&mdash;regardless of background&mdash;to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.
 
 
 
 Brief Job Overview
 
 
 
 This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab. This position is a component of USP&rsquo;s core business, and the incumbent is expected to support monograph modernization initiatives.
 
 
 
 How will YOU create impact here at USP?
 
 
 
 As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
 
 
 Additionally, USP&rsquo;s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
 
 
 
 The Scientist III Has The Following Responsibilities
 
 
 
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 Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
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 Apply technical and scientific expertise in analytical method development and validation of Small molecule projects.
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 Prepare the project plans, reports, laboratory notebook/ Laboratory management system (LMS) and compile project data as per requirement.
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 Adhere to GLP and safety practices while working in the Lab.
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 Practice Diversity, Equity, Inclusion, and Belonging principles at USP India.
 
 
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 Who is USP Looking For?
 
 
 
 The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience
 
 
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 Master&rsquo;s degree in chemistry or Pharmaceutical Sciences with 6-8 years of experience.
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 Possess a fine understanding of USP/NF monographs/general chapters/general notices.
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 Must have hands on experience in working with chemical methods and handling instruments like HPLC, FT-IR, UV-Visible.
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 Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
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 Should possess technical knowledge in the areas of Drug substance/ Drug products and different dosage forms.
 
 
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 Additional Desired Preferences
 
 
 
 Desired 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 disqualifies for candidate consideration.
 
 
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 Should have hands on experience in working with chemical methods and handling instruments like GC, IC, ICP-OES/MS, LC-MS, AAS and KF.
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 Should have fair understanding of GLP regulations and exposed to external regulatory audits.
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 Technical and analytical skills required including the ability to interpret technical information.
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 Exceptional breadth of Pharma industry experience.
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 Excellent technical writing and oral communication skills required.
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 Must be able to communicate effectively with diplomacy and enthusiasm.
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 Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity.
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 Awareness of ISO ISO/IEC 17025 is desirable.
 
 
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 </ul>
 
 Supervisory Responsibilities
 
 
 
 None, this is an individual contributor role.
 
 
 
 Benefits
 
 
 
 USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
 
 
 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.
 
 
 
 Job Category
 
 Chemistry &amp; Scientific Standards
 
 
 
 Job Type
 
 Full-Time
</div>

Scientist III, CDL

Join US Pharmacopeia and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

US Pharmacopeia

About Company

Senior Scientist I, Documentary Standards (Pipeline Biologics)

Scientist III, CDL