Annovex Pharma is a 503b Outsourcing Facility dedicated to providing our customers with uncompromising quality, reliability, and service in meeting their compounded sterile and non-sterile pharmaceutical product needs. Our employees enjoy a work culture that promotes innovation, integrity, honesty, accountability, fairness, and fun.

We are seeking a full-time Pharmacy Manager/Pharmacist-in-Charge (PIC) to join our team. This team member will report to the Director of Operations. This role is responsible for overseeing the production activities within the facility and ensuring all policies, procedures, standards, and objectives for services are in accordance with USP 797, cGMP, and DEA regulations. This position will also complete regulatory reporting, maintain quality assurance, and coordinate with all staff to provide the highest level of customer service. This role will supervise the pharmacists, pharmacy technicians and cleanroom staff. The PIC oversees all aspects of pre-production, cleanroom, and post-production.

This position is based in Lorton, Virginia.

The ideal candidate will have extensive knowledge of compounding sterile and non-sterile pharmaceuticals and knowledge of state and federal regulations governing pharmacy operations. Furthermore, this person will have demonstrated ability to build and maintain relationships, trust, and respect with clients and peers.

Responsibilities

The successful candidate will:

• Serve as pharmacist-in-charge and maintain state pharmacy licenses for our compounding facility in Lorton, Virginia
• Manage the execution of opening and closing activities; either directly, or through delegation to a staff pharmacist.
• Ensure strict cGMP procedures are followed throughout the facility.
• Represent the facility in all state and federal regulatory audits, stakeholder visits, and communication.
• Directly supervise the activities of all employees as they relate to product manufacturing. This includes training and overseeing the performance of pharmacists and pharmacy technicians.
• Work with leadership and staff members throughout the facility to ensure production goals and KPIs are created, tracked, and met.
• Ensure batch records are meticulously maintained, reviewed and verified.
• Identify trends or issues that are delaying batch production or causing batches to be cancelled.
• Create and maintain operational and production SOPs.
• Ensure compliance with all local, state, and federal regulatory requirements and laws regarding the practice of pharmacy, cGMP and the management of controlled substances.
• Answer clinical questions from health professionals and provide product information.
• Ensure safe work environments, enforcing operational discipline, and monitoring aseptic behaviors.
• 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.
• Coordinate and report product recalls.
• Write, review, and/or approve various cGMP documents such as customer complaint investigations, deviations, CAPAs, SOPs, and Annual Product Review reports.
• Work with all interdisciplinary and quality unit teams on CQI initiatives, deviation investigations, CAPAs and RCAs
• Provide pharmacist representation during regulatory (FDA, DEA, SBOP) and customer audits.
• Maintain compounding pharmacist training and competencies and compound pharmaceutical products as needed.
• Act as a working pharmacy manager, maintaining the competency and ability to perform staff pharmacist duties (compounding, batch review, labeling, etc.)

POSITION REQUIREMENTS

The successful candidate will have:

• Excellent verbal and written communication skills.
• Ability to supervise and participate in compounding activities in a clean room environment.
• Excellent attention to detail.
• Ability to lead and influence a team to achieve desired goals.
• Strong result-oriented leadership style
• Desire to grow within a growing company.

Supervisory Responsibilities

• This position will supervise compounding pharmacists, pharmacy technicians and cleaning personnel within a clean room environment.
• Employee management activities including training, work schedule management, approval of timesheets, performance appraisals, discipline and reward, addressing complaints and conflict resolution.

Work Environment

• As this position will be performed in a cGMP manufacturing environment, proper protective equipment is expected at all times. While in the cleanroom, the pharmacist-in-charge will perform hand hygiene and garbing pursuant to cGMP best practices.

Physical Demands

• Must be able to lift, push, pull and carry up to 40+ pounds.
• Must be able to sit or stand for 4+ hours at a time as needed.
• Will be completely covered in protective gear for long periods of time.
• Must be able to pass garbing requirements in a cGMP environment.

Qualifications:

Required:

• Doctor of Pharmacy (PharmD).
• Active Pharmacy License in Virginia.
• 5 years of experience managing or working with technicians.
• 2 years of direct work experience in a 503(a) pharmacy, 503(b) outsourcing facility, pharmaceutical manufacturers involved in sterile product manufacturing, or in an R&D or pharmacovigilance role in the pharmaceutical industry.
• Must be able to pass a background security check.
• Must be able to pass a drug screening test.

Preferred:

• Board certification in sterile compounding.
• At least five years of sterile compounding experience.
• Experience managing regulatory audits in the pharmaceutical industry (FDA, NABP, State Boards of Pharmacy, etc.)
• Experience drafting, reviewing and approving SOPs and Master Formulation Records directly related to sterile compounding

Annovex Pharma, Inc benefits include health care, life insurance, AD&D, paid time off, retirement savings and professional development. Employees can also take advantage of several corporate discounts.