What are the responsibilities and job description for the Sr. Scientist position at Hikma Pharmaceuticals?
Job Title: Senior Scientist
Summary:
Education and/or Experience
Cherry Hill, NJ, US, 08003
Summary:
- This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of raw materials, components and manufacturing processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted, and process improvements are evaluated/ implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.
- 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.
- 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.
- Ability to work any shift (1st, 2nd, or 3rd) and any day of the week (7 days) as duties require.
Education and/or Experience
- BS preferably in the Engineering/Pharmaceutical Sciences (other degrees accepted provided the individual has relevant equipment validation experience) having a minimum of 5 years related experience or 4 years related experience w/ an advanced degree.
Cherry Hill, NJ, US, 08003
