Sr. Supervisor, Drug Product Manufacturing

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. Supervisor, Drug Product Manufacturing who is responsible for the implementation of all production and manufacturing procedures to optimize processes and regulatory requirements. This position coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment.

Responsibilities:

• Overseeing daily operations including formulation, filtration, filling and troubleshooting any issues.             
• Batch record Review and generation.
• Strategic planning with DP manufacturing. Defining the schedule, coordinating prep, and troubleshooting.  
• Participates in client calls, interactions and meetings including kick off meeting, tours, and resolving operational issues.                        
• Internal investigations (Deviations, Corrective Actions, Preventative Action, Product Quality reviews).                                      
• Facility planning for shutdowns, maintenance, HEPA certifications, and media fill planning.                                             
• Audit Responses (Client, QP, and Regulatory Inspections, SOP and Batch record revisions).                                           
• Quality interactions (EM investigations, OOS investigations, Deviation Investigations).
• 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 Althea’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 Drug Product Manufacturing.
• Identifies, recruits, and retains top-notch talent.
• Champions Ajinomoto’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 Ajinomto’s policies and procedures.
  
  

Requirements:

•  Bachelor’s degree in a Life Sciences discipline or equivalent required.
• A minimum of five (5) years of relevant technical experience. Minimum of one (1) year leadership experience.
• Understanding of cGMP's.   
• Understanding of regulatory requirements. 
• Solid command of chemistry including understanding of fillers and processes regarding filling. 
• Understanding of QAD, Master Control, LIMS, and RAM.

The anticipated salary range for candidates who will work in California is $94,950.98 - $124,623.16

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.