Sr. Manager, Microbiology – Bioburden & Endotoxin
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 Sr. Manager, Microbiology – Bioburden & Endotoxin. This position leads teams across multiple sites and is responsible for the development, implementation, and maintenance of Microbiology laboratory testing. The Sr. Manager represents the department in internal and external meetings including interacting with clients and following up on client inquiries.
- Manages Microbiology laboratory testing for standard microbiological tests, including bioburden and endotoxin, and ensures compliance with government and company standards and regulations.
- Manages implementation and maintenance of quality systems, including but not limited to, SOP’s, deviations, and personnel training.
- Manages method development, protocol preparation, qualification execution, and report approval.
- Manages deviation and out-of-specification reports and investigations, and tracking the effectiveness of preventive action.
- Oversees contract lab testing activities.
- Oversees the contamination control program for the high potency facility, ensuring utilities and facilities conform to company standards and to regulatory requirements.
- Oversees environmental action level reports and investigations and trend reports, and tracking the effectiveness of preventive actions.
- Serves as a liaison between the Company and auditors.
- Coordinates testing including validation and qualification, and the dissemination of the results of those activities to the relevant internal and external customers.
- Analyzes data to provide proposals for future directions; capable of critical review.
- Makes recommendations for corrective action to assure conformity with quality specifications.
- Prepares and present department KPIs to senior and executive leadership.
- Responsible for meeting deadlines under a tight timeline and changing priorities.
- Embodies Althea’s cultural values and aligns daily interactions with departmental goals and company culture.
- Bachelor’s degree in a Life Sciences discipline – Microbiology preferred.
- Minimum of eight (8) years relevant experience in Microbiology.
- Minimum of five (5) years of leadership/supervisory experience.
- Experience with GMP, aseptic techniques, troubleshooting, and data entry.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Demonstrated ability to follow detailed directions in a laboratory environment.
- Must be familiar with Microsoft Office applications.
- Familiarity with MODA is a plus.
- Manages and provides expert knowledge in the day-to-day function of the Microbiology 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, engages and develops 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.
Successful Candidate must pass a background check and drug screen as a condition of employment.
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.