Senior Manager, Microbiology

Why join Ajinomoto Bio-Pharma?

Our mission is to help improve the health of humankind.

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.

Total Rewards package designed to make your life better:

We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

We are currently seeking a Sr. Manager of Microbiology that directs and provides expert knowledge to the development, implementation, and maintenance of Quality Control (QC) microbiology systems and activities. This position oversees next level leaders to manage daily schedules for routine Environmental Monitoring (EM), data management, enumeration and laboratory testing while communicating critical escalations related to production, business needs, and/or facility activities. The Sr. Manager of Microbiology is responsible for the management of the CGMP QC Microbiology group and assures utilities, facilities, materials and products conform to company standards and satisfy global regulations (i.e. FDA, EMA, PMDA, etc.)

Responsibilities:

• Drives performance and continuous improvement, while managing diligent execution of day to day performance.
• Is effective at root cause analysis and overseeing effective implementation actions.
• Manages all quality control microbiology activities and oversees hiring, training, and developing QC micro personnel.
• Establishes and communicates high performance standards through meaningful KPIs, defines clear accountability, and leads by adopting improvement strategies to reduce operational variances and increase efficiency.
• Creates and approves the EM PQ process for new facilities and equipment.
• Sets short-term and long term department goals and deploys goals to the department staff.
• Coordinates QC micro functions with operation activities and cross departmental staff for multiple sites and fill lines at Lusk and Roselle.
• Ensures implementation and maintenance of quality systems, including but not limited to SOP writing, deviations, trend reports, personnel training, ACT reports, CAPAs and Complaints.
• Interacts professionally with clients for process development, transfer, testing and monitoring activities.
• Interact with regulatory inspectors as needed regarding QC Microbiology and EM
• Represents the company as the subject matter experts (SME) for microbiological matters and addresses client inquiries.
• Performs phase appropriate investigations and makes recommendations for corrective action necessary to assure conformity with quality specifications
• Demonstrates aptitude to influence clients, peers and leadership on critical compliance and business interfaces.
• Represents department in internal and external audits. Responsible for on-time resolution of audit deficiencies.
• Analyzes data and results and provides conclusions and proposals for final reports; capable of critical review.
• Oversees staff competency and /or training in all aspects of testing, CGMPs, SOPs (standard operating procedures), company policies and safety.
• Ensures compliance activities are performed on time.
• Builds effective partnerships with department heads to help drive the business toward achieving company objectives.
• Regular and reliable attendance on a full time basis or in accordance with posted schedule.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Embodies Aji Bio-Pharma's cultural values and aligns daily actions with department goals and company culture.

Leadership Responsibilities:

• Directs and provides expert knowledge in the day-to-day function of Microbiology.
• Identifies, recruits, and retains top-notch talent.
• Champions Aji Bio-Pharma'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 Aji Bio-Pharma's policies and procedures.
  
  

Requirements:

• Bachelor's degree in a Life Sciences discipline or equivalent experience required.
• Minimum of seven (7) years relevant experience in Quality Control Microbiology.
• Minimum of three (3) years of supervisory experience.

• Significant experience with GMP, USP, EM, contamination control, aseptic techniques and troubleshooting.
• Demonstrated ability to manage, motivate and mentor scientific personnel and encourage teamwork.
• Detail oriented with strong written, verbal communication and presentation skills.

• Proficiency with Microsoft Office applications.

The anticipated salary range for candidates who will work in California is $118,516.84 to $158,943.00

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states. If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.

New hires will be asked to complete a background check and drug screen as a condition of employment.

For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO

We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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