Job Title: Compounding Pharmacist (Sterile Injectables)Job Description
The Compounding Pharmacist (Sterile Injectables) is responsible for managing and executing aseptic compounding operations within a 503B sterile manufacturing environment. This role requires overseeing 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 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.
Responsibilities
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 SOPs.
Plan, coordinate, and supervise batch compounding processes for sterile injectables, including measuring and mixing ingredients, operating validated compounding equipment, and performing sterile filtration methods.
Maintain thorough and accurate compounding records, batch production documents, and logs for all compounded lots.
Enforce adherence to all relevant regulations and guidelines, including FDA 21 CFR Part 210/211, USP and , and state pharmacy laws.
Supervise and mentor pharmacy technicians and other compounding staff in aseptic technique, cleanroom behavior, and proper use of equipment.
Work closely with the QA/QC team to ensure all compounded products meet quality specifications and coordinate environmental monitoring and sterility testing programs.
Collaborate with operations management to optimize production workflows and throughput while maintaining compliance and quality.
Monitor inventory levels of raw materials and components, ensuring timely availability and proper storage, with verification of materials prior to use.
Stay current with advancements in sterile compounding technology and relevant regulations, attending training or continuing education as needed.
Essential Skills
Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy.
Active and unrestricted New York State pharmacist license.
Minimum 5 years of experience in sterile compounding, with significant experience in a 503B outsourcing facility or similar cGMP sterile manufacturing environment.
In-depth understanding of FDA regulations for 503B facilities and current Good Manufacturing Practices (cGMP).
Proficiency in aseptic techniques and working in controlled cleanroom environments.
Excellent attention to detail with respect to documentation and record-keeping.
Strong leadership and interpersonal skills to supervise and coordinate with cross-functional teams.
Demonstrated ability to troubleshoot compounding processes or equipment issues.
Additional Skills & Qualifications
Familiarity with the Drug Quality and Security Act (DQSA) and relevant FDA guidance documents.
Experience with sterile filtration, autoclave sterilization, and operation of other validated compounding equipment.
Capability of overseeing environmental monitoring and understanding sterility assurance practices.
Ability to train others and enforce protocols in a respectful, constructive manner.
Work Environment
Work is performed on-site in a state-of-the-art sterile compounding cleanroom facility. The environment includes ISO Class 7 cleanroom areas with ISO Class 5 primary engineering controls. Strict adherence to gowning and personal protective equipment (PPE) requirements is mandatory. The role requires extended periods of standing, especially while working at laminar flow hoods. Occasional lifting of containers or equipment may be needed. The position involves routine donning and doffing of cleanroom attire. The work environment is highly regulated and quality-focused, with continuous environmental monitoring. The pharmacist must follow all safety protocols, including handling of hazardous drugs per USP . The position is full-time, typically conducted during standard business hours, with flexibility required to meet production schedules or to oversee processes after hours.
Job Type & Location
This is a Permanent position based out of Colonie, NY.
Pay and Benefits
The pay range for this position is $70.00 - $100.00/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 Jan 30, 2026.
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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
