Job Title: Senior Scientist
Location: Cherry Hill NJ
Job Type: Fulltime
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.
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.
Essential Duties and 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.
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.
- 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.
What We Offer*:
- 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
- Safety and Quality is a top organizational priority
- Career advancement and growth opportunities
- Tuition reimbursement
- Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
