Company: United States Pharmacopeia (USP)
Location: Hyderabad, India
Industry Type: Pharma/Healthcare/Clinical Research
Employment Type: Full-time
Application Deadline: 25th November 2024
Job Overview
United States Pharmacopeia (USP) is seeking a Team Lead, Senior Scientist II in our Analytical Research & Development Laboratory. This supervisory role involves the isolation and purification of known and unknown impurities, characterization of compounds, and method development for in-process samples from our synthetic lab. The successful candidate will ensure compliance with safety and GLP standards while leading critical research projects.
Key Responsibilities
- Project Oversight (50%)
- Review isolation and purification processes using preparative HPLC and various analytical techniques.
- Prepare development reports for synthetic support projects (USP-NF and PAI).
- Coordinate with lab scientists to meet project timelines and ensure project requirements are fulfilled.
- Equipment Maintenance (20%)
- Oversee equipment calibration and the execution of IQ/OQ/PQ for new instruments.
- Ensure GLP compliance and implement safety procedures in the lab.
- Safety and Compliance (20%)
- Develop and implement safety projects and SOPs within the ARD lab.
- Collaborate with Quality Assurance to ensure compliance with corrective actions and participate in audits.
- Diversity and Inclusion (10%)
- Promote principles of Diversity, Equity, Inclusion, and Belonging within the USP India team.
Candidate Profile
- Education:
- MSc in Analytical Chemistry/Organic Chemistry/M.Pharm with 13-15 years of relevant experience or Ph.D. with 10-13 years of experience in Analytical Research and Development.
- Experience:
- Hands-on experience with HPLC and preparative HPLC; knowledge of analytical techniques such as LCMS, GCMS, FTIR, UV-Visible, NMR is required.
- Exposure to GMP/GLP environments and documentation practices.
- Skills:
- Strong problem-solving abilities, technical writing, and communication skills.
- Proficient in electronic lab notebook (ELN) systems; knowledge of Empower and NuGenesis is a plus.
- Familiarity with additional analytical techniques (XRD, TGA, DSC, IC, ICP-MS) is advantageous.
- Interpersonal Skills:
- Proven ability to work effectively in a team-oriented environment with strong interpersonal skills.
Additional Information
- Experience Required: 5+ years in a relevant field.
- Key Attributes: Strong work ethic, attention to detail, and ability to multi-task.
Equal Opportunity Employer
USP is committed to equal opportunity and affirmative action. Employment decisions are made without regard to sex, gender identity, race, age, disability, religion, national origin, color, veteran status, or any other protected class. We strive to provide reasonable accommodations to individuals with disabilities.