Join the Fisher BioServices team as the Sr. Operations Manager in Frederick, Maryland. Fisher BioServices is the industry leader in the management of critical biological materials to support the advancement of cell therapy, GMP biologics, and population-based public health research. This Sr Operations Manager will be the Site Leader of a new 50,000 square foot Cryocentre facility and oversee a team of approximately 12 employees (direct and indirect).
Essential Duties and Responsibilities:
- Oversee operations with a focus on Quality, Validation, and Facilities compliance using our Standard Operating Procedures (SOPs) and input from our QA as a guide. Work closely with landlord to insure site is maintained to regulatory compliance form a facilities perspective.
- Ensures that all aspects of each client contract is followed, and works to maintain proper operations of all aspects of the Frederick Cryocentre facility.
- Responsible for meeting operational fiscal requirements for current and new business activities.
- Develop CAPEX (capital expense) requirements and annual operating budget (AOP) for areas of focus. Review all purchases and invoices generated from your team.
- Interact with clients as necessary to assist in sales, prospective, current, and regulatory audits and visits; follow-up to direct client contact via email or face-to-face.
- Responsible for data retention and archives, data entry, inventory for the repository.
- Assures client/sponsor documentation is complete, accurate and issued in a timely fashion.
- Responsible for packaging and shipping of drug in vapor phase nitrogen dry shippers and all aspects of the logistics function domestic and global to support these operations.
- Responsible for government and regulatory compliance including OSHA, accident reporting, and ensuring compliance to cGMP standards.
- Works closely with the QA Manager to develop and implement training programs for operations.
- Conducts fair and accurate performance reviews on time, orientation training, and provides periodic feedback and coaching on performance.
- Day-to-day coordination of multiple repository projects in process.
- Other duties may be assigned to meet business needs.
- High School diploma or equivalent required; Bachelors degree in a science related field is preferred.
- 5+ years management of repository operations: shipping, receiving, and/or ultra-cold temperature storage.
- Work experience in an FDA regulated environment.
- A good understanding of ISO 9000 and cGMP quality standards is preferred.
- Experience reviewing processes to improve effectiveness through data collection, measuring, analysis, improvement and control.
- Familiarity with various deviation and complaint management system, metrology systems, validation equipment, data management, temperature monitoring systems.
- Proven ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Proven ability to comprehend company and corporate goals, objectives, policies and procedures and develop the necessary measures to achieve them.
- Self-starter with the ability to work with minimal supervision; supervision is remote.
- Ability to prepare reports using Excel; knowledge of Windows, Word and Power Point.
- Expert ability to work with methods to handle, process, and store specimens in an ultra-cold environment.
- Knowledge of Universal Precautions, general laboratory and quality assurance/control.
- Ability to role model behavior consistent with company values.
- High level of integrity and reliability for database and inventory management.
- Ability to multi-task in multi-disciplines on a day to day basis including Operations, Project, QA, and Facilities Management skills.
- Ability to respond to on-call in support of site 24/7/365 for events such as afterhour’s temperature, intrusion, fire alarms, power failures, or weather related events.
- A valid driver’s license and good driving record is required to utilize company vehicle to transport material.
Direct management of Operations (4-6) and matrix management of other functions at the site.
Work Conditions/Physical Requirements:
- Must have ability to work in a temperature controlled environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents. May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.
- Must use personal protective equipment and adhere to safety protocols.
- Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
- Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C) for up to 6 hours per day.
- Minimal travel required (5%)