Analytical Chemist II /Bio-Chemist (Pharmaceutical Manufacturing)

Job Type

Full-time

Description

Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!

With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.

**Multiple positions available in QC and R&D**

Job Summary:

The role of QC Biochemist/Analytical Chemist II is responsible for supporting the operations and manufacturing process by performing routine and non-routine analytical testing raw materials, in-process, finished formulations, stability samples, method development and/or transfers, and cleaning validations. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Responsible for the safe and efficient execution of job duties.

JOB DUTIES & RESPONSIBILITIES:

• Conduct routine analytical/microbiological testing of raw materials, packaging materials, finished product release and stability using approved methods and various instrumentation while adhering to cGMP and established policies.
• Conduct analytical USP method verifications, validations, and method transfer activities for raw materials and finished dosage forms.
• Perform the Calibration, Qualification, Preventive maintenance and routine trouble shooting of analytical instruments like UPLC, HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF Auto titrator, FT-IRS spectrophotometer, Polarimeter and Refractometer.
• Compile laboratory test data and perform appropriate analyses that include physical (solubility, viscosity),chemical (titration) and analytical (FTIR, HPLC, ICP-MS, UV-Vis, KF, IC) testing etc.
• Complete documentation needed to support testing procedures including test forms and logbooks.
• Interpret test results, compare them to established specifications and control limits, and ensure appropriateness of data for release. Treats data with a high level of integrity and ethics.
• Participate in out-of-specification and failure investigations. Support all aspects of laboratory investigations.
• Prepare, review and approve analytical data, technical reports and analytical methods.
• Coordinate Microbiological, preservative efficacy/ antimicrobial effectiveness testing requirement as per USP/USP-NF for Active pharmaceutical ingredients, Inactive and Finished products and stability samples for regulatory filings.

Physical Requirements/Working Environment:

• Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
• Commitment to long hours of work when necessary to achieve goals.
• Respirator, lab coat and safety glasses required. Ability to work with potent substances using a glove-box.

Job Type : Full-time

This Job Is Ideal for Someone Who Is:

• Dependable - more reliable than spontaneous
• People-oriented - enjoys interacting with people and working on group projects
• Adaptable/flexible - enjoys doing work that requires frequent shifts in direction
• Detail-oriented - would rather focus on the details of work than the bigger picture
• Achievement-oriented - enjoys taking on challenges, even if they might fail
• Autonomous/Independent - enjoys working with little direction
• Innovative - prefers working in unconventional ways or on tasks that require creativity
• High stress tolerance - thrives in a high-pressure environment

Requirements

Preferred Knowledge & Skills:

• Strong knowledge of the major analytical techniques: HPLC/UPLC, GC, dissolution, etc. FT-IR, FDA/ICH regulations.
• Solid knowledge of FDA/ICH regulations.

Required Experience & Education:

• BS or MS in Chemistry, Pharmacy, Biochemistry, Biology or Biotechnology or related field.
• Minimum 2 - 5 years of experience in using analytical instrument techniques including HPLC/GC/FT-IR, UV-Vis, Dissolution Apparatus, Ovens/Auto Titrators/KF Titrator/Particle size analyzers/ Ion-Chromatography.