Senior Scientist, Parenteral RMQ & Validation

RXinsider LTD.; Cherry Hill Township, Northern (NJ, KY); Hybrid; USD 67,000 - 134,000; Full time

Benefits offered by this job

Annual bonus

401(k) with Hikma match

PTO 20 days

Personal days

Company holidays

Health benefits

Employee discount

Wellbeing program

Tuition reimbursement

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Senior Scientist at our Cherry Hill, NJ facility to support parenteral manufacturing qualification and validation.

The role involves writing and executing RMQ protocols, investigating manufacturing challenges, and contributing to process improvements; final documents support regulatory audits. You will mentor staff, manage complex projects, and ensure compliance with FDA guidelines while working in a team-driven, fast-paced environment.

Qualifications

• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Proficient in Microsoft Word and Excel, Visio. Proficient in technical writing.
• Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines including RMQ stream.
• Knowledgeable of FDA guidelines for Justification of Specification (JOS) and RMQ documents.
• Proficient in writing Change Controls, CAPAs, Investigations, Protocols, Reports and Deviations.
• Must be able to identify opportunities for optimization of processes within the department or the plant.
• Ability to work independently or in teams.
• Ability to walk some distance 1-3 miles, stand for 3-6 hours and lift 10 - 40 lbs. during the course of a work day as required.

Responsibilities

• Applies thorough understanding of cGMP, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Performs a variety of projects/studies in areas that include Raw Material Qualification (API and Excipients), Components Qualification (Primary & Secondary Components), as well as projects/studies to support implementation / filling.
• Handles projects that are more complex and broader in scope, such projects require team leadership, task prioritization, and management of budget and/or time constraints. Must demonstrate competent and effective planning, coordination, and organizational skills.
• Writes/Reviews RMQ / Sampling protocols, reports, Change Controls. Conducts Studies/Executes protocols.
• Provides mentoring and leadership to less experienced staff.

Skills

Communication

Project management

Autonomy

Teamwork

Process optimization

Technical writing

Education

BS in Engineering/Pharmaceutical Sciences

Tools

Microsoft Word

Microsoft Excel

Visio

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Senior Scientist at our Cherry Hill, NJ facility to support parenteral manufacturing qualification and validation.

The role involves writing and executing RMQ protocols, investigating manufacturing challenges, and contributing to process improvements; final documents support regulatory audits. You will mentor staff, manage complex projects, and ensure compliance with FDA guidelines while working in a team-driven, fast-paced environment.