Let’s Make Things Happen!
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.
Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.
Althea is currently seeking a Manager, Facilities responsible for managing the activities of the staff and third party vendors to maintain a reliable, secure and compliant site at Althea’s newest facility in San Diego. The Manager, Facilities establishes a culture of continuous improvement and strengthens Althea’s ability to troubleshoot programs, identify root causes and make appropriate corrective actions.
- Manages and supervises the activities of the Facilities Maintenance staff and third party vendors to maintain a reliable, secure and compliant site.
- Provides Facilities support to research, development, clinical and commercial biotechnology operations including bulk production and aseptic filling activities.
- Provides input on capital projects to upgrade or expand facilities and equipment needed. Assists in planning, execution and documentation.
- Helps ensure compliance of the site with a specific focus on Facilities operations relative to applicable US and international regulatory agencies including OSHA and FDA.
- Manages staff and coordinates Facility shutdowns to ensure preventive maintenance (PM) and repairs are completed in a timely manner, including all necessary documentation.
- Ensures that department resources are available to promptly respond to and resolve Facility problems as needed at all times.
- Manages third party service provider relationships; maintains a master contact list and ensures that appropriate service agreements are in place and vendors are appropriately trained and qualified.
- Supports timely closure of facility related cGMP deficiencies including audit observations, corrective and preventative actions (CAPA) and deviations.
- Assists in establishing KPI’s including staying within the budget, and ensures staff support and meet KPI’s. Takes corrective actions to mitigate performance gaps.
- Bachelor’s degree in a related discipline or equivalent training and experience required.
- Minimum of seven (7) years of experience in Facilities, including cGMP pharmaceutical bulk and aseptic filling operations.
- Minimum of three (3) years of leadership/supervisory experience.
- Detail oriented with strong written and verbal communication skills.
- Demonstrated ability to follow detailed directions in a laboratory environment.
- Must be familiar with Microsoft Office applications.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Manages and provides expert knowledge in the day-to-day function of the Facilities group.
- Identifies, recruits, and retains top-notch talent.
- Champions Althea’s culture and empowers employees to take responsibility for their jobs and goals.
- Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
- Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
- Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
- Provides oversight and direction to the employees in accordance with Althea’s policies and procedures.
If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
We are an EOE dedicated to a diverse work force and Drug Free work environment.Qualified M/F/D/V candidates are encouraged to apply.