Analytical Development Scientist

On-Site Analytical Development Scientist

Job Description

This role focuses on performing analytical testing to support the development, validation, and control of raw materials, intermediates, and finished products in a regulated laboratory environment. The Analytical Development Scientist executes and optimizes analytical methods, maintains complex instrumentation, and ensures data integrity and compliance with GMP and applicable regulatory requirements. The position offers the opportunity to contribute directly to chemical development initiatives while working closely with cross-functional teams and external laboratories.

Responsibilities

+ Perform analytical testing to support the development, validation, and control of raw materials, intermediates, and finished products.

+ Execute analytical assays using both established and newly developed methodologies.

+ Operate, troubleshoot, and maintain laboratory instrumentation, including HPLC, GC, GC/MS, LC/MS, FTIR, titrators, and particle size analyzers.

+ Set up, optimize, and refine analytical methods for compound identification, purity determination, and potency analysis.

+ Document all experimental work accurately and comprehensively in laboratory notebooks and formal reports.

+ Ensure strict compliance with GMP standards, standard operating procedures (SOPs), and applicable regulatory requirements, including those related to controlled substances (e.g., DEA).

+ Support the transfer of analytical methods to Quality Control and Process Support teams by preparing documentation, training materials, and technical guidance.

+ Coordinate external analytical testing with third-party laboratories, including sample submission and data review.

+ Generate, interpret, and analyze analytical data to support reference material qualification and other development activities.

+ Collaborate with internal teams to support Chemical Development initiatives and contribute to cross-functional project goals.

+ Perform additional laboratory duties and support tasks as assigned to ensure efficient laboratory operations.

Essential Skills

+ Hands-on experience operating and maintaining HPLC systems for analytical testing.

+ Proficiency with gas chromatography (GC) and mass spectrometry techniques, including GC/MS and LC/MS.

+ Experience using FTIR, titrators, and particle size analyzers in a laboratory setting.

+ Strong background in wet chemistry techniques and analytical method execution.

+ Practical knowledge of GMP requirements and working in a regulated laboratory environment.

+ Ability to follow and develop SOPs and adhere to laboratory best practices.

+ Solid foundation in chemistry, including analytical and organic chemistry principles.

+ Experience in laboratory-based development activities, particularly related to APIs or chemical development.

+ Master's Degree in Chemistry with 2+ years of relevant industry experience, OR Bachelor's Degree in Chemistry with 6+ years of relevant industry experience.

+ Strong documentation skills with the ability to maintain accurate laboratory records and reports.

+ Ability to analyze and interpret analytical data to support development and qualification activities.

Qualifications

+ Master's Degree in Chemistry with 2+ years of relevant industry experience, OR Bachelor's Degree in Chemistry with 6+ years of relevant industry experience.

+ Experience supporting analytical method transfer to Quality Control or Process Support teams.

+ Familiarity with DEA or other controlled substance regulatory requirements in a laboratory setting.

+ background in API development or related pharmaceutical or chemical development activities.

+ Ability to work effectively in cross-functional teams and collaborate with internal and external stakeholders.

+ Interest in pursuing either a traditional scientist-level career progression or a technical specialist track.

+ Comfort working with multiple analytical platforms and adapting to new technologies and methods.

Work Environment

The position is based in a regulated laboratory environment with a standard Monday through Friday day shift schedule, totaling a 40-hour work week. Some overtime may be required to meet project…