Senior Scientist I/ Scientist IV Bioanalytical
Senior Scientist I/ Scientist IV Bioanalytical
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Job 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 workan 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
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. USPs 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 Analytical Reference Materials documentary standards and characterization of different 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 USPs public health mission of increasing equitable access to high-quality safe medicine and improving global health through public standards and related 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 USPs mission goals and objectives and complies with USPs guidelines and other requirements.
- Demonstrates laboratory skills and hands on expertise in analytical Chromatography SEC-MALS LC-MS HPLC/UPLC Ion-chromatography Capillary Electrophoresis Biochemical assays SDS-PAGE Western blot IEF Enzymatic/Protein assays (Spectrophotometer and Plate readers).
- Technical knowledge in Circular dichroism FTIR Gas chromatography NMR is an added advantage.
- 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 cell and gene therapy 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 USPs 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:
Senior Scientist I -
- MSc././. in relevant stream of Biological Sciences with 11-13 (Or) Ph.D with 7-10 years of industry experience working in Analytical R&D and/or QC department of Biopharmaceutical industry and has hands on experience in work recombinant therapeutic proteins peptides mAbs and /or CGT and Vaccines.
- The candidate should be well-versed with operation and troubleshooting of all instruments used in performing the analytical characterization of the molecules and should have sound knowledge of QMS systems.
- The candidate should have strong competencies in technical writing communication and presentation skills.
Scientist IV
- MSc././. in relevant stream of Biological Sciences with 8-10 (Or) Ph.D with 4-7 years of industry experience working in Analytical R&D and/or QC department of Biopharmaceutical industry and has hands on experience in work recombinant therapeutic proteins peptides mAbs and /or CGT and Vaccines.
- The candidate should be well-versed with operation and troubleshooting of all instruments used in performing the analytical characterization of the molecules and should have sound knowledge of QMS systems.
- Experience in method development validation and technology transfer and analytical characterization for biomolecules is an added advantage
- Work experience in cGLP/cGMP environment is preferred.
- The candidate should have strong competencies in technical writing communication and presentation skills.
Additional Desired Preferences
- 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 specificwritten agreement with USP.
Required Experience:
Senior IC
Employment Type
Full-Time
