Empower Pharmacy
Analytical Research and Development Scientist 503B
Empower Pharmacy, East Windsor, New Jersey, United States
Analytical Research and Development Scientist 503B
Position Summary
The Analytical Research and Development Scientist is crucial to Empower’s mission of delivering innovative, high-quality, and affordable medications that improve lives and expand healthcare access. This role develops and validates analytical methods, ensuring the integrity and compliance of drug substances and products across sterile and non-sterile dosage forms. With a focus on innovation and collaboration, this position provides the opportunity to directly impact patient outcomes.
Duties and Responsibilities
Supports the design, optimization, and validation of robust analytical methods for characterizing drug substances and drug products across sterile and non-sterile dosage forms using techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Gas Chromatography-Mass Spectrometry (GC-MS), Fourier Transform Infrared Spectroscopy (FTIR), and Ultraviolet-Visible Spectroscopy (UV‑VIS), ensuring compliance with regulatory guidelines including United States Pharmacopeia (USP), European Pharmacopeia (EP), and International Council for Harmonisation (ICH).
Performs analytical testing to support formulation development, stability studies, and release testing, including evaluation of compatibility samples, formulation intermediates, drug substances, and final drug products.
Conducts critical tests such as content uniformity, assay development, impurity analysis, and other product‑specific analytical assessments to ensure quality and compliance.
Executes the maintenance, calibration, and troubleshooting of laboratory instruments to ensure optimal performance and adherence to quality standards.
Provides guidance and mentorship to junior scientists, fostering skill development and ensuring technical excellence within the laboratory team.
Physical Requirements The employee is required to talk and hear, remain in a stationary position for a significant amount of the workday, frequently use hands and fingers to handle or feel items, retrieve and enter information into the computer and other office devices, move around the office and corporate campus, stand, walk, reach with arms, climb or balance, stoop, kneel, crouch or crawl.
Knowledge and Skills
Strong critical thinking, problem‑solving, and collaboration skills, with the ability to adapt in fast‑paced environments, foster cross‑functional teamwork, and drive innovation in analytical development.
Advanced technical proficiency in analytical methodologies such as HPLC, UPLC, GC, GC‑MS, FTIR, and UV‑VIS, along with expertise in regulatory frameworks including USP, EP, ICH, and current Good Manufacturing Practices (cGMP).
Key Competencies
Customer Focus: Ability to build strong customer relationships and deliver customer‑centric solutions.
Optimizes Work Processes: Knows the most effective and efficient processes to get things done, focusing on continuous improvement.
Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
Resourcefulness: Secures and deploys resources effectively and efficiently.PARAGRAPH
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Duties and Responsibilities
Supports the design, optimization, and validation of robust analytical methods for characterizing drug substances and drug products across sterile and non-sterile dosage forms using techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Gas Chromatography-Mass Spectrometry (GC-MS), Fourier Transform Infrared Spectroscopy (FTIR), and Ultraviolet-Visible Spectroscopy (UV‑VIS), ensuring compliance with regulatory guidelines including United States Pharmacopeia (USP), European Pharmacopeia (EP), and International Council for Harmonisation (ICH).
Performs analytical testing to support formulation development, stability studies, and release testing, including evaluation of compatibility samples, formulation intermediates, drug substances, and final drug products.
Conducts critical tests such as content uniformity, assay development, impurity analysis, and other product‑specific analytical assessments to ensure quality and compliance.
Executes the maintenance, calibration, and troubleshooting of laboratory instruments to ensure optimal performance and adherence to quality standards.
Provides guidance and mentorship to junior scientists, fostering skill development and ensuring technical excellence within the laboratory team.
Physical Requirements The employee is required to talk and hear, remain in a stationary position for a significant amount of the workday, frequently use hands and fingers to handle or feel items, retrieve and enter information into the computer and other office devices, move around the office and corporate campus, stand, walk, reach with arms, climb or balance, stoop, kneel, crouch or crawl.
Knowledge and Skills
Strong critical thinking, problem‑solving, and collaboration skills, with the ability to adapt in fast‑paced environments, foster cross‑functional teamwork, and drive innovation in analytical development.
Advanced technical proficiency in analytical methodologies such as HPLC, UPLC, GC, GC‑MS, FTIR, and UV‑VIS, along with expertise in regulatory frameworks including USP, EP, ICH, and current Good Manufacturing Practices (cGMP).
Key Competencies
Customer Focus: Ability to build strong customer relationships and deliver customer‑centric solutions.
Optimizes Work Processes: Knows the most effective and efficient processes to get things done, focusing on continuous improvement.
Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
Resourcefulness: Secures and deploys resources effectively and efficiently.PARAGRAPH
I can't finish.{
#J-18808-Ljbffr