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Description

The Compounding Pharmacist (Sterile Injectables) is responsible for managing and executing aseptic compounding operations within a 503B sterile manufacturing environment. This role reports directly to the Pharmacist-in-Charge (PIC) and oversees the production of sterile injectable medications, ensuring full compliance with FDA 503B regulations, USP and guidelines, and company Standard Operating Procedures (SOPs). The pharmacist will utilize their extensive experience (minimum 5 years in 503B sterile compounding) and New York State pharmacist licensure to lead batch production processes, maintain documentation, and collaborate with Quality Assurance/Quality Control (QA/QC) and production teams to drive operational excellence and patient safety. Aseptic Compounding Oversight: Oversee and participate in the preparation of sterile injectable medications in an ISO Class 5 cleanroom hood within an ISO Class 7 environment, maintaining strict aseptic technique and compliance with current Good Manufacturing Practices (cGMP), USP / standards, and facility SOPsjobtarget.com. Ensure all activities meet FDA 503B outsourcing facility requirements and the Drug Quality and Security Act (DQSA) guidelinesjobtarget.com. Batch Production Management: Plan, coordinate, and supervise batch compounding processes for sterile injectables. This includes measuring and mixing ingredients, operating validated compounding equipment (e.g. sterilizers, filtration devices), and performing sterile filtration methods to achieve required sterility assurance levels. Verify that each batch is prepared accurately and efficiently, with proper in-process controls and compliance documentation. Documentation & Record-Keeping: Maintain thorough and accurate compounding records, batch production documents, and logs for all compounded lots. Review and verify compounding worksheets, labels, and quality control results to ensure traceability and compliance. All documentation must meet regulatory standards and good documentation practices for 503B productionsourpharma.net. Regulatory Compliance & SOP Adherence: Enforce adherence to all relevant regulations and guidelines. Ensure that compounding practices comply with FDA 21 CFR Part 210/211, USP (sterile compounding) and USP (hazardous drugs) requirements, as well as state pharmacy laws. Participate in the development, review, and continuous improvement of SOPs and batch records to reflect current best practices and regulatory updatesourpharma.net. Team Leadership & Training: Supervise and mentor pharmacy technicians and other compounding staff in aseptic technique, cleanroom behavior, and proper use of equipment. Provide training on sterile compounding procedures and safety protocols, and oversee staff performance to ensure all activities in the cleanroom maintain ISO 5/7 standards and prevent contaminationourpharma.net. Foster a culture of quality, safety, and teamwork on the production floor. Quality Assurance Collaboration: Work closely with the QA/QC team to ensure all compounded products meet quality specifications. Coordinate environmental monitoring, media fill tests, and sterility testing programs in the cleanroom as needed. Investigate any compounding deviations or out-of-specification results, implement corrective actions (CAPA), and contribute to root cause analyses to prevent recurrence Operational Excellence: Collaborate with the PIC and operations management to optimize production workflows and throughput while maintaining compliance and quality. Assist in validating new compounding processes or equipment and in qualifying cleanroom facilities. Identify opportunities for process improvements or cost efficiencies in line with lean principles without compromising safety or compliance. Inventory & Supply Coordination: Monitor inventory levels of raw materials, components (vials, filters, packaging), and consumables used in sterile compounding. Work with the supply chain/warehouse team to ensure timely availability of materials and proper storage (e.g., controlled temperature or quarantine when needed). Verify that all materials used are within expiry and released by QA prior to use. Continuous Learning: Stay current with advancements in sterile compounding technology, changes in USP chapters /, and FDA guidance for 503B facilities. Attend relevant training or continuing education (such as the Board of Pharmacy Specialties BCSCP certification) to enhance expertise. Apply this knowledge to maintain the facility’s state of compliance and to mentor staff on best practices.

Skills

Pharmd, cgmp, 503b, pharmacist, sterile compounding, pharmaceutical

Top Skills Details

Pharmd,cgmp,503b,pharmacist

Additional Skills & Qualifications

Education & Licensure: Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy. Active and unrestricted New York State pharmacist license is required. Experience: Minimum 5 years of experience in sterile compounding, with significant experience in a 503B outsourcing facility or similar cGMP sterile manufacturing environment. Proven track record of supervising aseptic production of sterile injectables at scale is essential. Regulatory Knowledge: In-depth understanding of FDA regulations for 503B facilities and current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210/211. Strong knowledge of USP standards for sterile compounding and USP for handling hazardous drugsjobtarget.com. Familiarity with the Drug Quality and Security Act (DQSA) and relevant FDA guidance documents. Technical Skills: Proficiency in aseptic techniques and working in controlled cleanroom environments (ISO Class 7 cleanroom and ISO Class 5 laminar flow hoods). Experience with sterile filtration, autoclave sterilization, and operation of other validated compounding equipment. Capable of overseeing environmental monitoring and understanding sterility assurance practices. Quality & Documentation: Excellent attention to detail with respect to documentation and record-keeping. Experience reviewing and maintaining batch records, SOPs, deviation reports, and other quality documents in a regulated environment. Ability to follow Good Documentation Practices to ensure data integrity. Leadership & Communication: Strong leadership and interpersonal skills to supervise pharmacy technicians and coordinate with cross-functional teams (e.g., QA/QC, operations, management). Excellent communication skills, both written and verbal, for effective documentation and team collaboration. Ability to train others and enforce protocols in a respectful, constructive manner. Problem-Solving: Demonstrated ability to troubleshoot compounding processes or equipment issues and to

Experience Level

Intermediate Level

Job Type & Location

This is a Contract to Hire position based out of Colonie, NY.

Pay and Benefits

The pay range for this position is $60.00 - $80.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Colonie,NY.

Application Deadline

This position is anticipated to close on Dec 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.