Pharmacy Manager/ Pharmacist in Charge

This position will report directly to the Director of Corporate Quality and Compliance (PharmD).

The Pharmacy Manager / Pharmacist-in-Charge (PIC) is responsible for applying clinical knowledge to appropriateness of formulation, processes, and procedures related to sterile pharmaceutical manufacturing and related activities in a 503B Outsourcing Facility.

The Pharmacy Manager / PIC will work collaboratively with other pharmacists, technicians, and various staff members to manufacture sterile drug products to fill customer orders in compliance with all regulatory requirements and company policies and procedures.

Quality Assurance Pharmacists and Regulatory Support Technicians will report to the Pharmacy Manager / PIC.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions

• Review and verify formulation (compounding) activities and documentation performed by technicians and other support staff for completeness, accuracy, and adherence to cGMPs. Such verifications may require ISO 8 cleanroom gowning attire and functions.
• Perform the final review and release of batches.
• Ensuring compliance with all federal, state, and local regulations related to facility activities, USP 797, cGMP, and controlled substances
• Author, review, and/or approve various cGMP documents such as customer complaint investigations, adverse drug event investigations, deviations, CAPAs, SOPs, Change Controls, Master Product Batch Records, and Annual Product Review reports.
• Create, update, and approve product labels and determine appropriate label content per applicable regulations.
• Train manufacturing technicians to perform pharmaceutical calculations.
• Perform DEA recordkeeping activities.
• Perform required federal and state regulatory reporting as applicable.
• Efficiently utilize tools and metrics (KPI’s) to monitor staff productivity, deliverables, timelines, and quality of work product to adjust staffing levels and operational processes as needed to ensure operational effectiveness.
• Participate in internal audits, regulatory inspections, and customer audits as necessary.
• Answer clinical questions from physicians, nurses, and other healthcare providers.
• Work collaboratively with members from various teams to achieve company goals.
• Maintaining active pharmacist licenses in all states that require PIC licensing.
• Other duties as assigned.

Supervisory Responsibilities

• Directly supervise Quality Assurance Pharmacists and Regulatory Support Technicians.
• Foster a positive and productive work environment, providing guidance, coaching, and mentoring.
• Conduct regular 1:1’s to address performance, feedback and relationship building.
• Identify training and development needs within the team and facilitate as able.

Experience and Necessary Skills

• Pharmacy Degree (PharmD preferred)
• Licensed Pharmacist in the state of site location (Colorado) and all states that require PIC licensing. Candidates without all required licenses will be required to obtain all necessary licenses after hire.
• 3 years’ experience in a 503(b) outsourcing facility OR R&D or pharmacovigilance role in the pharmaceutical industry OR other relevant management experience required, 5 years preferred.

• Familiarity & Understanding of Sterile Manufacturing/Processing (USP testing, sterilization techniques, etc.) preferred
• Familiarity & Comprehension of regulations including DQSA, 21 CFR 211 and USP guidelines, as applicable.
• Good computer skills, including but not limited to Word, Excel, PowerPoint
• Excellent interpersonal and communication skills, both verbal and written
• Ability to assume responsibility and act on own initiative
• Ability to lead and influence a team to achieve desired goals
• Good self-management, organizational and planning skills
• Ability to adhere to strict deadlines and procedures
• Excellent reasoning and critical thinking skills
• Hands- on approach with a “can-do” attitude and results orientation
• Good listener, but proactive in group discussions

Benefits

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Flexible Spending & Health Savings Accounts (FSA & HSA) available
• Dental & Vision insurance
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program

Timeline: We will be accepting applications on an ongoing basis until position is filled.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.