Scientist I, AR&D

Granules Pharmaceuticals, Inc.; Chantilly (VA); On-site; USD 70,000 - 90,000; Full time

Job summary

Granules Pharmaceuticals, Inc. is seeking a Scientist I for its Analytical R&D team in Chantilly, Virginia. The role involves testing product development samples and performing analytical method validation. Candidates must have a Bachelor's degree in Pharmaceutical Chemistry or related fields, along with at least 5 years of relevant experience.

The position requires proficiency in laboratory instrumentation such as HPLC and GC, and good documentation practices. Knowledge of cGMP and excellent communication skills are essential.

Qualifications

• 5+ years of directly related experience in pharmaceutical industry.
• 2+ years of experience with a Master's degree in a related field.
• Knowledge of Good Manufacturing Practices (cGMP).

Responsibilities

• Conduct analytical method development and validation.
• Test product development samples and support the R&D team.
• Document experiments accurately in compliance with FDA guidelines.

Skills

Knowledge of analytical techniques

HPLC Method development & validation

Documentation as per Good Documentation Practice

Computer skills including Microsoft Word and Excel

Excellent verbal and written communication skills

Education

Bachelor's degree in Pharmaceutical Chemistry or related

Master's degree in Pharmaceutical Chemistry or related

Tools

HPLC

GC

FTIR

UV-VIS Spectrophotometer

Malvern Mastersizer

Job description

Job Type

Full-time

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 the R&D team on a 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 Include 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 compliance 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 experience in pharmaceutical industry.
• Master's degree in Pharmaceutical Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related area with 2+ years of directly related experience 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.
• Experience 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.