Job Information
The U.S. Pharmacopeial Convention (USP) Senior Scientist I/II/Principal Scientist, Biologics Pipeline Development in Rockville, Maryland
Description
A comprehensive pipeline of next generation biological standards encompassing different therapeutic areas is critical for the implementation of the Global Biologics strategy. The Senior Scientist I/II/Principal Scientist in Biologics Pipeline Development is a hands-on non-supervisory role that will be responsible for identifying and evaluating opportunities for new biological standards and developing and implementing laboratory studies to assess feasibility and establish proof of concept. The incumbent will leverage their knowledge of biologics development and analytical testing to identify and assess opportunities for development of new standards and develop and implement feasibility and proof-of-concept laboratory studies. The scientist will lead roundtables, working groups, discussions and development activities with global stakeholders, including industry experts, consortia, vendors, USP volunteers, and external collaborators.
Roles and Responsibilities
Identifies opportunities for new standards and solutions to address analytical challenges associated with the next generation of biological medicines. Plans and executes industry roundtables aimed to gather input from stakeholders, works with technical writers and marketing teams on delivery and posting of summaries and white papers as applicable.
Develops strategies and processes for the elaboration of a steady pipeline of standards to support the analytical evaluation of different classes of biotherapeutics.
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.
Develops relationships with key stakeholders from academia and industry to engage in collaborations in early pipeline development projects. Leads collaborations with academic collaborators and stakeholder groups.
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 in support of feasibility and proof of concept studies.
Partners with the standards production team leads for eventual handoff leading to planning and initiation of standards development projects.
Supports USP to build its external presence through presentations at conferences and publications.
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.
Keeps abreast of current trends and developments in related scientific fields, particularly in the area of monoclonal antibodies and/or therapeutic proteins.
Basic Qualifications
Sr. Scientist I:
Ph.D. degree in Analytical Chemistry, Biochemistry, Biology, or a relevant field. Minimum of five (5) years of experience with bioanalytical development in the pharmaceutical industry.
MS. level candidates with minimum of seven (7) years of commensurate experience.
Combination of relevant work experience and education may be substituted
Experience in process development, analytical characterization, and chemistry and manufacturing control (CMC) for biotherapeutics.
Minimum of 5 years of experience working in a regulated biopharmaceutical environment.
Sr. Scientist II:
Ph.D. degree in Analytical Chemistry, Biochemistry, Biology, or a relevant field. Minimum of eight (8) years of experience with bioanalytical development in the pharmaceutical industry.
MS. level candidates with minimum of ten (10) years of commensurate experience.
Combination of relevant work experience and education may be substituted
Experience in process development, analytical characterization, and chemistry and manufacturing control (CMC) for biotherapeutics.
Minimum of 5 years of experience working in a regulated biopharmaceutical environment.
Principal Scientist:
Ph.D. degree in Biochemistry, Biology, Pharmacy, or a related field and ten (10) years, or M.S. degree and twelve (12) years of relevant experience in analytical development for biotherapeutics.
Experience in process development, analytical characterization, and chemistry and manufacturing control (CMC) for biotherapeutics.
Minimum of 5 years of experience working in a regulated biopharmaceutical environment.
Preferred Qualifications
Strong experience in the areas of characterization and analysis of biopharmaceuticals.
Knowledge of reference standards related to biopharmaceutical products/industry. Experience with reference materials development is a plus.
Experience in method development and characterization of biological products, impurities, and raw materials using a variety of physicochemical techniques and biological assays.
Demonstrated 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, method development and reference standard evaluation.
Expertise in analytical methods applicable to biotherapeutics, including HPLC, capillary electrophoresis, and ELISA. Experience in mass spectrometry, and/or bioassays is a plus.
Experience in method development, qualification and/or validation, method transfer, and development of system suitability criteria.
Demonstrated stakeholder collaboration experience, with the ability to develop and manage internal and external relationships and contacts.
Ability to establish and nurture relationships with individuals of varying backgrounds and learning styles.
Excellent presentation and communication skills (written and oral).
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. Ability to persuade corporations to collaborate with USP on various projects.
Effective at operating independently where appropriate yet understands when to escalate issues and how to establish effective working relationships.
Able to perform in a fast-paced environment with changing deadlines and priorities. Ability to manage and prioritize multiple, concurrent projects.
Supervisory Responsibilities
N/A
Benefits
USP 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 are protected.
About USP
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. 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.
The following COVID-19 provisions will apply to selected candidate(s) hired:
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The 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
Job Type Full-Time