Assistant Manager/Sr Specialist - Formulation R&D

Role overview

Responsibilities

• Develop differentiated formulations and use innovative technologies while meeting timelines and good laboratory and documentation practices.
• Conduct lab trials and stability studies; review and compile data and document experiments in ELN.
• Search scientific literature and compile experimental data to support product-development decisions.
• Write and review protocols, reports, validation plans, and development reports in compliance with quality systems.
• Coordinate with analytical development, quality assurance, regulatory affairs, and other cross-functional teams; escalate issues for timely approvals.
• Support milestone timelines and delivery; prepare and review SOPs and technology transfer documents.
• Comply with quality, regulatory, and EHS requirements; support applications for R&D, clinical, and import licenses.
• Support laboratory facility development and maintenance, troubleshooting, investigations, and corrective and preventive actions.

Qualifications

• Pharm or Ph.D. in Pharmacy and at least three years of industrial pharmaceutical development and product scale-up experience are required.
• Expertise in immediate- or modified-release solid oral dosage forms and/or immediate-release oral suspensions or solutions is preferred.
• Global product development experience is preferred, with the United States as the core area.
• Branded and differentiated 505(b)(2) product experience and CRO/CDMO experience are preferred.
• Applicants should be well versed in Microsoft Office applications.

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