Job Title: Scientist II, Product Transfer
Location: Cherry Hill, NJ
Job Type: Full time
Req ID: 6903
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 750 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 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Scientist II, Product Transfer to join our team. In this role, you will be responsible for supporting the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment, raw materials, 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.
Key Responsibilities:
Under moderate oversight by senior team member or manager:
Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
Performs a variety of projects/studies in areas that may include Product/Process, sterilization, Cleaning and Equipment Validation, as well as projects/studies to support Manufacturing Operations.
Writes protocols, reports (GTRs), Change Controls (including MARs). Conducts Studies/Executes protocols.
Serves as project lead with projects of intermediate scope and cross-functional teams.
Mentors and provides leadership to junior team members.
Handles routine tasks timely, accurately.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
- Minimum Education: Minimum of a BA or BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations)
- Minimum Experience: A minimum of 3+ years pharmaceutical validation experience (2+ years of validation with an advanced degree or demonstrated performance within Technical Services)
Skills:
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Proficient in Microsoft Word and Excel, computer software.
- Direct industry knowledge.
- 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
- Ability to become clean room gown trained/qualified and to work within the sterile suite areas for up to a full 8-hour shift (with appropriate breaks)
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.