Scientist I, AR&D

Smart Media; Chantilly (VA); On-site; USD 70,000 - 90,000; Full time

Job summary

Smart Media is hiring a Scientist I for their Analytical R&D team in Chantilly, Virginia. In this role, you will oversee product testing, method validation, and compliance with good manufacturing practices while supporting the R&D team effectively.

The ideal candidate will have a Bachelor's or Master's degree in a relevant field and significant industry experience. Skills in HPLC and analytical techniques are essential, along with excellent communication abilities.

Qualifications

• 5+ years of experience in the pharmaceutical industry or 2+ years with a Master's degree.
• Knowledge of Good Manufacturing Practices (cGMP).
• Experience with relevant software systems like Empower.

Responsibilities

• Testing product development samples and supporting analytical testing.
• Conducting analytical method development and validation.
• Documenting experiments and ensuring compliance with SOPs.

Skills

Analytical techniques

HPLC method development

Excellent communication skills

Documentation skills

Proficiency in Microsoft Excel

Education

Bachelor's degree in Pharmaceutical Chemistry or related

Master's degree in Pharmaceutical Chemistry or related

Tools

HPLC

GC

FTIR

ICP-MS

UV-Vis

Job description

Job Summary

US Based Candidates Only**

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 in 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

• Proficient in operating 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 MasterSizer, and others.
• Support the R&D team by testing process development samples for content uniformity, blend uniformity, assay, particle size distribution, density, water determination by KF, viscosity, and other required tests.
• Conduct analytical method development, method optimization, method validation, method verification, and method transfer for finished products.
• Draft test methods, validation protocols, and reports as per company SOPs and regulatory guidelines.
• Perform additional analytical testing (multimedia dissolution, photo stability, dose dumping, etc.) for ANDA submission.
• Execute and complete assigned tasks in a timely manner.
• 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 following good housekeeping practices and cGMP compliance.
• Identify and communicate continuous improvement opportunities to the Analytical Manager and Director.
• Monitor and ensure availability of chemicals, columns, standards, and other consumables for sample testing.
• Other duties assigned by management based on requirements.

Management Responsibilities

• Assign daily work schedule in a 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 the pharmaceutical industry, OR
• Master's degree in Pharmaceutical Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related area with 2+ years of directly related experience in the 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 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 and validation.
• Proficient in documentation as per Good Documentation Practice.
• Computer skills including Microsoft and Excel.
• Excellent verbal and written communication 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.