Compounding Pharmacist

Hikma Pharmaceuticals•Cherry Hill, NJ

35d

About The Position

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. We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and Compounding Pharmacist will support the Associate Director of Operations and is responsible for supervising production operations of Compounded Sterile Preparations by implementing and maintaining Sterile Compounding policies/strategies in alignment with all regulatory authorities/guidance's and Hikma Corporate plans and policies. The Compounding Pharmacist will also evaluate any possible significant trends across the site and help drive continuous improvement efforts to adhere to regulatory requirements.

Requirements

Bachelor of Pharmacy or PharmD required.
State of New Jersey license as a pharmacist is required. Multiple state licenses preferred or ability to obtain state license for the following (AL, AR, ID, KS, MI, MS, NV, NY, OH, OK, KY, VA).
503B Compounding experience and/or USP 797 knowledge and experience required.
Knowledge of sterile compounding practices.
Knowledge of associated standards and operating procedures in relation to cGMP.
Knowledge of 503B practices, aseptic processes (gowning, garbing, gloving etc.)
A broad perspective to organize objectives, both long-term and day-to-day activities
Pharmacist for a 503B outsourcing facility located in New Jersey preferred
New Jersey licensure is required, as well as the ability to obtain multiple state licenses.
The ability to change direction and focus to meet shifting organizational and business demands.
The ability to create and contribute to an environment that values people encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
The ability to effectively manage self, demonstrate integrity, be productive under pressure, and achieve development goals.
The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
The ability to manage multiple resources and be accurate and current with data and information.
Ability to communicate technical information to non-technical personnel

Nice To Haves

Previous experience with 503B outsourcing, USP 797, and/or hospital IV compounding would be an advantage.

Responsibilities

Ensure adherence to batch records and aseptic techniques.
Monitor Compounding personnel for compliance with gowning, behavior and aseptic technique.
Conduct Investigations for manufacturing deviations.
Execute CAPAs & Change Controls.
Provide Aseptic Training
Provide oversight of compounding and production activities, ensuring compliance with the FDA CFR, including cGMP and DEA regulations, as well as State Board of Pharmacy rules and regulations.
Keep abreast of relevant guidance documents pertaining to 503B production.
Monitor and communicate changes in regulations of all state and federal regulatory agencies.
Assist in new 503B product development, including collaborating on labeling, stability study protocols, Master Batch Records, and product specification requirements ensuring compliance with all company procedures and federal and state laws, rules, and regulations.
Attain all non-resident Pharmacist licenses within 1 year.
Assist the Associate Director of Compounding Operations in daily oversight of compounding personnel and compounding operations in cleanroom environments.
Review, prepare and approve manufacturing deviations, master batch records and site change controls related to 503B Compounding Operations.
Participate in the administration of Site Projects and New Product Launches to support 503B operations.
Assist in the development and provision of GMP, Aseptic Behavior, and Quality Systems-related training to all applicable departments.
Provide technical support in the interactions with and applications to state and federal regulatory bodies.
Provide assistance in collection of documents and records regarding state licensing and renewals for state boards of pharmacy.
Assist in writing, review and update of batch records, SOPs, and other cGMP documents.
Maintain current pharmacist licenses in required states, as directed.
Other duties as assigned.

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
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.