Location: Hyderabad, India
Industry: Pharma/Healthcare/Clinical Research
Functional Area: Documentary Standards
Qualification: MSc or Ph.D. in Biochemistry, Analytical Chemistry, or Biological Sciences
Experience: Minimum 5 years
End Date for Application: 30th December 2024
About USP
The U.S. Pharmacopeial Convention (USP) is a trusted independent scientific organization committed to ensuring the quality, safety, and benefit of medicines, dietary supplements, and food ingredients globally. USP collaborates with top health and science authorities to develop global standards aimed at strengthening the supply of safe, quality medicines worldwide. USP believes that Equity = Excellence, reflected in their core value of Passion for Quality.
Job Description
USP is looking for a Senior Scientist II in the Documentary Standards group to support the reference standard program within the Global Biologics department. This is a non-supervisory, non-laboratory position in the India Biologics Department.
Responsibilities:
- Develop and manage reference standards for biotechnology pharmaceutical products, including proteins, peptides, heparins, antibiotics, and advanced therapies.
- Address analytical challenges in biological medicines by facilitating the development of standards and solutions.
- Oversee the stability program for the USP Biologics RS catalog inventory.
- Review historical testing data and prepare test protocols based on requirements.
- Support laboratories to ensure accurate and timely completion of testing.
- Review and evaluate laboratory reports, assess results, and determine the suitability of reference standards.
- Compile historical and current data into stability testing reports.
- Collaborate with various USP departments on data assessments and test planning.
- Respond to stakeholder inquiries related to reference standards.
Candidate Profile:
- Educational Requirements:
- Ph.D. in Biochemistry, Analytical Chemistry, or Biological Sciences with 7-10 years of post-educational experience OR
- MSc in Biochemistry or Biological Sciences with 11-13 years of industrial experience.
- Technical Skills:
- Hands-on experience with analytical techniques such as HPLC, LC-MS, CE, cIEF, ELISA, SPR, ddPCR/qPCR.
- Experience in method development, product characterization, and impurity analysis.
- Ability to write technical reports on material characterization and method development.
- Experience:
- At least 5 years in recombinant therapeutic proteins, peptides, gene therapy, vaccines, and carbohydrates.
- Prior experience in compendial, pharmaceutical, or biotechnology industries is preferred.
- Additional Skills:
- Strong communication skills, both written and verbal.
- Strong interpersonal skills with the ability to work collaboratively across teams.
- Ability to handle shifting priorities in a fast-paced environment.
- Excellent organizational and multitasking abilities.
How to Apply
Interested candidates can apply by submitting their resume and relevant documents by 30th December 2024.