Sr. Scientist

Hikma Pharmaceuticals USA Inc.•Cherry Hill, NJ

1d•Onsite

About The Position

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.

Requirements

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.
Knowledgeable of FDA guidelines for Justification of Specification (JOS) and RMQ documents.
Proficient in writing Change Controls, CAPAs, Investigations, Protocols, Reports and Deviations.
Ability to work independently or in teams.
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.

Nice To Haves

May be considered a Subject Matter Expert (SME) in various disciplines including RMQ stream.

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.
Writes/Reviews RMQ / Sampling protocols, reports, Change Controls.
Conducts Studies/Executes protocols.
Provides mentoring and leadership to less experienced staff.
Must demonstrate competent and effective planning, coordination, and organizational skills.
Must be able to identify opportunities for optimization of processes within the department or the plant.

Benefits

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave