Analytical Research and Development at U.S. Pharmacopeial

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Analytical Research and Development at U.S. Pharmacopeial


PositionScientist II, ARD
CompanyU.S. Pharmacopeial Convention
LocationHyderabad, India
Experience Required3 – 6 years
QualificationsM.Sc in Analytical Chemistry/Organic Chemistry, M.Pharm
Job TypeVerified Job, Online Application
Key SkillsPreparative HPLC, FTIR, GMP/GLP, documentation, QA, teamwork
PerksWork-life balance, paid time off, healthcare, retirement plans
Application DeadlineNovember 20, 2024
Analytical Research and Development at U.S. Pharmacopeial

About U.S. Pharmacopeial Convention (USP)

The U.S. Pharmacopeial Convention (USP) is an independent, non-profit scientific organization committed to enhancing the quality and safety of medicines, dietary supplements, and food ingredients globally. USP’s mission-driven approach, supported by over 1,300 professionals across 20 global locations, prioritizes equity, excellence, and scientific integrity. USP’s Hyderabad facility is seeking a Scientist II to join its Analytical Research and Development (ARD) team, contributing to the development of high-quality reference materials. Analytical Research and Development at U.S. Pharmacopeial

Role Overview: Scientist II, ARD

As a Scientist II in the ARD team at USP, you will focus on advancing the quality of pharmaceuticals through analytical research, particularly in the area of isolation and purification of compounds. This non-supervisory role requires technical expertise in preparative high-performance liquid chromatography (HPLC) and hands-on experience with analytical instruments. You’ll be part of a dynamic team, working in a regulated environment that upholds Good Laboratory Practice (GLP) standards to ensure safety and quality. Analytical Research and Development at U.S. Pharmacopeial

Key Responsibilities

1. Isolation and Purification Projects (60%)

Your primary responsibility will involve conducting isolation and purification projects to ensure high-quality reference standards. This includes:

  • Performing compound isolation using preparative HPLC.
  • Monitoring reactions, conducting scale-up studies, and completing the final analysis of samples.
  • Documenting project results in detailed reports to support research and development efforts.
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2. Instrument Management (15%)

USP places high value on the maintenance and proper functioning of laboratory equipment:

  • You will oversee the qualification of new instruments, ensuring IQ/OQ/PQ standards are met.
  • Manage inventory and lab supplies, collaborating with the Purchasing department for timely replenishment.
  • Comply with GLP standards to ensure a safe working environment for all team members.
    Analytical Research and Development at U.S. Pharmacopeial

3. Documentation and Standard Operating Procedures (SOPs) (10%)

Documentation is vital for maintaining quality standards:

  • Prepare, review, and update SOPs, protocols, and research reports.
  • Ensure proper calibration of lab equipment, supporting data accuracy and reliability.

4. Quality Assurance and Audits (10%)

You’ll be actively involved in USP’s quality management processes:

  • Contribute to ISO-9001 certification and participate in QA audits.
  • Address audit findings proactively, ensuring compliance and continuous improvement within USP’s laboratories.
    Analytical Research and Development at U.S. Pharmacopeial

5. Diversity and Inclusion Initiatives (5%)

USP values a culture of inclusivity, where diversity is celebrated and respected:

  • Actively practice and promote principles of diversity, equity, inclusion, and belonging within USP India, fostering a supportive workplace.

Candidate Profile

USP seeks candidates with a strong background in analytical research and hands-on experience with analytical chemistry instruments. The ideal profile includes:

  • Educational Background: MSc in Analytical Chemistry, Organic Chemistry, or M.Pharm.
  • Professional Experience: 3-6 years of experience in Analytical Research and Development.
  • Technical Skills:
  • Proficiency in preparative HPLC, including method development and optimization.
  • Familiarity with FTIR, wet chemistry techniques, and a solid understanding of GMP/GLP environments.
  • Additional experience with synthetic organic molecules and analytical chemistry fundamentals.
    Analytical Research and Development at U.S. Pharmacopeial
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Analytical Research and Development at U.S. Pharmacopeial
Analytical Research and Development at U.S. Pharmacopeial

Essential Skills and Abilities

To excel in this role, USP expects candidates to demonstrate a blend of technical, communication, and interpersonal skills:

  • Analytical Skills: Ability to execute complex isolation and purification projects with precision and accuracy.
  • Problem-Solving: Adaptable and resourceful, able to address challenges in a research setting.
  • Communication: Strong technical writing skills for documentation, along with the ability to communicate effectively within the team.
  • Team Orientation: Collaborate effectively with peers in a regulated environment.

Additional Preferred Qualifications

While not mandatory, USP appreciates candidates with added expertise that can enhance their role within the ARD team:

  • Technical Proficiency: Experience with LCMS, spectroscopic techniques, and other advanced analytical tools.
  • Software Knowledge: Familiarity with electronic laboratory notebooks (ELN), Empower, and NuGenesis.
  • Customer Communication Skills: Ability to manage client inquiries and uphold USP’s standards for customer service.
    Analytical Research and Development at U.S. Pharmacopeial

Benefits of Working at USP

USP offers a comprehensive benefits package to support employee well-being, which includes:

  • Work-Life Balance: Flexible schedules that enable a balanced lifestyle.
  • Paid Time Off: Generous leave policies for personal time and rejuvenation.
  • Healthcare Options: Access to health plans that safeguard your well-being.
  • Retirement Savings: Financial planning support to secure your future.

Application Process

If you are a detail-oriented professional with a passion for scientific research and quality assurance, USP encourages you to apply. Submit your application by November 20, 2024, and join USP in its mission to deliver safe, high-quality medicines worldwide. To apply, visit the official USP website or submit your resume and cover letter. Analytical Research and Development at U.S. Pharmacopeial

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This job description provides a comprehensive look at the Scientist II, ARD role at USP in Hyderabad, highlighting the responsibilities, qualifications, and growth opportunities available to prospective candidates.

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Analytical Research and Development at U.S. Pharmacopeial
Analytical Research and Development at U.S. Pharmacopeial

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