Analytical Development - Injectable & Complex Injectable
This role supports the development of drug substances and drug products by contributing to the design and execution of analytical methods used to evaluate quality attributes across various Injectable dosage forms. The position assists in evaluating proposed formulation trials through quantitative, qualitative, and performance-indicative testing to align product profiles with reference formulations. It plans and executes controlled research experiments on trial batches, including exposure and stability studies, while maintaining accurate scientific records. The role supports the setting of product specifications and performs analytical method validation to confirm the suitability of methods against defined specification ranges. It ensures the operation and compliance of laboratory environments, including equipment setup, configuration, installation, and maintenance, while upholding data integrity standards for regulatory submissions. The position supports stability studies and coordinates day-to-day activities across multiple projects to meet regulatory submission timelines. It contributes to analytical method transfers to commercial sites and assists in troubleshooting activities related to commercial support. The role also participates in computational and experimental chemistry-based research during various stages of the R&D cycle, building scientific knowledge and delivering new methodologies. It leverages experimental data to inform key decisions and shape the direction of research programs within a global pharmaceutical organization.
Essential Functions:
Additional Responsibilities:
Education:
Experience:
Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
