Scientist I, AR&D

Description

**US Based CANDIDATES ONLY**

Job Summary:

As a Scientist I on our Analytical R&D team, you would be responsible for testing the product development samples and supporting R&D team on timely manner with analytical sample testing. This includes performing the Assay Dissolution, analytical method development, and method validation including preparing analytical method validation and verification protocols . Additionally, you would be responsible for the testing and release of in-process, finished product, and Stability samples including process evaluation samples.

Following SOPs to complete tasks, while ensuring safe and efficient execution of job duties is crucial in this role.

Job Duties and responsibilities inclue but not limited to:

• Proficient in operating the laboratory instrumentation/equipment, including but not limited to: FTIR, HPLC, UPLC, Dissolution apparatus, ICP-MS, GC, UV-Vis, Karl fisher (KF), Ion chromatography (IC), Malvern Master sizer, etc.
• Support the R&D team by testing the process development sample for content uniformity, blend uniformity, Assay, particle size distribution, density, water determination by KF, viscosity, and other tests as required.
• Conduct analytical method development, method optimization, method validation, method verification and method transfer for finish products.
• Draft test methods, method validation protocols and reports as per the Company SOPs and regulatory guidelines
• Perform additional analytical testing (multimedia dissolution, photo stability, Dose dumping etc.) for ANDA submission
• Timely execution and completion of assigned tasks
• Document experiments accurately and complete all associated documents (Instrument, Standard and Column usage logbooks) in compliance with internal SOPs and FDA guidelines
• Maintain work area and laboratory with good housekeeping practices and in compliant with cGMP.
• Identify and communicate continuous improvement opportunities to the Analytical Manager and Director
• Monitor and ensure availability of chemicals, columns, standards, and other consumable for sample testing.
• Other duties assigned by management based on requirements

Management responsibilities include:

• Assign daily work schedule in timely manner
• Provide guidance in method Development and validation.
• Interpret and review generated results
• Provide assistance in professional development.

Requirements

Minimum Education & Experience:

• Bachelor's degree in Pharmaceutical Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related area with 5+ years of directly related expereince in pharmaceutical industry OR
• Master's degree in Pharmaceutical Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related area with 2+ years of directly related expereince in pharmaceutical industry
• Knowledge of Good Manufacturing Practices (cGMP)
• Experience with software and information systems (e.g. Empower, Microsoft word and Excel)

Required Knowledge, Skills, & Abilities

• Proven Knowledge of the major analytical techniques and operation of instruments such as HPLC, GC, dissolution, FT-IR, UV-VIS Spectrophotometer, Particle size analysis (Malvern Mastersizer, Sonic sifting and Sieve shaker), Karl Fisher Instrument, Potentiometric Titration, Density meter, pH meter, Melting point apparatus, Analytical Balances, Viscometer
• Expereince with HPLC Method development & validation
• Proficient in documentation as per Good Documentation Practice
• Computer skills including Microsoft and Excel
• Excellent verbal and written communication and skills

Physical Requirements/Working Environment:

• Must be able to stand for long periods of time (up to 12-hour shifts), maneuver at least 40 pounds, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE.
• Vision - ability to see details at close range (within a few feet of the observer).

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.