Hikma Pharmaceuticals
Hikma Pharmaceuticals provided pay range
This range is provided by Hikma Pharmaceuticals. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $66,600.00/yr - $133,750.00/yr
Purpose The 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.
Key Accountabilities
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.
Primary Accountabilities
Assist the Associate Director of Compounding Operations ,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.
Qualifications Minimum:
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
Experience Minimum:
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.
Previous experience with 503B outsourcing, USP 797, and/or hospital IV compounding would be an advantage.
Skills
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
What We Offer
Clean climate-controlled working environment
401k employer match up to 6% of your contributions
23 vacation/personal days
11 paid Company holidaysEmployee discount program
Safety and Quality is a top organizational priority
Career advancement/growth opportunities
Tuition Reimbursement
Maternity and Parental Leave
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Manufacturing, Science, and Production
Industries Pharmaceutical Manufacturing, Manufacturing, and Retail
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Base pay range $66,600.00/yr - $133,750.00/yr
Purpose The 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.
Key Accountabilities
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.
Primary Accountabilities
Assist the Associate Director of Compounding Operations ,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.
Qualifications Minimum:
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
Experience Minimum:
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.
Previous experience with 503B outsourcing, USP 797, and/or hospital IV compounding would be an advantage.
Skills
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
What We Offer
Clean climate-controlled working environment
401k employer match up to 6% of your contributions
23 vacation/personal days
11 paid Company holidaysEmployee discount program
Safety and Quality is a top organizational priority
Career advancement/growth opportunities
Tuition Reimbursement
Maternity and Parental Leave
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Manufacturing, Science, and Production
Industries Pharmaceutical Manufacturing, Manufacturing, and Retail
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