Description
Brief Job Overview
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
This is a hands-on, non-supervisory individual contributor position in which the incumbent applies their knowledge and practical experience in execution of bioanalytical projects on collaborative testing of reference standards, documentary standards and characterization of biological products. Additionally, the incumbent will also actively engage and contribute in verification, international and national reference standard development programs as assigned.
How will YOU create impact here at USP?
In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.
Roles and Responsibilities
Aligns with USP’s mission, goals and objectives and complies with USP’s guidelines and other requirements.
Demonstrates laboratory skills and hands on expertise in analytical Chromatography (HPLC/UPLC/ Ion-chromatography), Capillary Electrophoresis, SEC-MALS, Circular-dichroism and Mass-spectrometry.
Perform Intact Mass, Peptide mapping, Glycan profiling, HMW & LMW, HCP, Impurity Profiling studies & PTM analysis
Plans and executes Compendial and R&D projects besides contributing in the new initiatives viz., proof of concept studies in Biologics for product classes such as proteins, enzymes, vaccines, monoclonal antibodies, peptides, antibiotics, raw material and any other biological products as assigned.
Ability to plan, design, execute, and resolve technical issues within the scope.
Evaluates and analyzes scientific reports, applies personal experience, academic training, and technical insights to troubleshoot and solve problems in the laboratory within the scope.
Performs administrative responsibilities, mentors and trains team member/members as assigned.
Actively engages in project coordination with cross-functional/global teams and aligns with Global Biologics objectives.
Prepares and reviews project reports, SOPs, and other documents to ensure compliance to USP’s Quality Management System and contribute in Internal audits, ISO 9001 and ISO 17025 audits
Assists and recommends improvements in laboratory/project management methods and processes.
Performs other duties as assigned.
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:
Ph.D. degree in Biochemistry, Analytical Chemistry or Biological Sciences . Minimum of 7 to 10 years of post-educational relevant work experience in either recombinant therapeutic proteins, peptides, mAbs and /or CGT and Vaccines areas.
M.Sc./M.Tech./M.Pharm. in relevant stream of Biological Sciences with 11-13 years of industry experience working in Analytical R&D and QC department of Biopharmaceutical industry.
Experience in method development, validation and technology transfer and analytical characterization for biomolecules.
Must have experience include strong technical knowledge and practical experience of peptides and mAbs or CGT and Vaccines area.
Work experience in cGLP/cGMP environment.
Knowledge of reference standards development and collaboration related to biopharmaceutical products, reference materials manufacturing and development.
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.
The candidate should be well-versed with operation and troubleshooting of all instruments used in performing the above-mentioned analytical techniques and should have sound knowledge of QMS systems.
Previous experience working in biopharma cGLP/cGMP/QMS environment with practical experience in good documentation practices would be an advantage.
The candidate should have strong competencies in technical writing, communication, and presentation skills.
Good written and verbal communications skills
Supervisory Responsibilities
None
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.
0 Comments