Manager, Drug Product Manufacturing - Formulations

Location
92121, San Diego
Posted
Jan 18, 2019
Required Education
Bachelors Degree
Position Type
Full time

Let’s Make A Difference!

 

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

 

Every team member at Ajinomoto Bio-Pharma Services, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.

 

We believe our people are the greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come. If you enjoy working in a fast-paced, inspiring, and values-driven culture, Ajinomoto Bio-Pharma Services is the place for you.

 

Together, Let’s Make A Difference.

 

Ajinomoto Bio-Pharma Services is currently seeking a Manager, Drug Product Manufacturing – Formulations to provide strong leadership and technical expertise to complex formulations manufacturing.

 

This position is responsible for managing the day to day activities of complex formulations manufacturing and implementing all production and manufacturing equipment and procedures to optimize processes and regulatory requirements. The Manager coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment.

 

 

Responsibilities:

  • Oversees daily operations including formulation, filtration and troubleshooting any issues.             
  • Batch record review and generation (Client calls and Project Management interactions).                
  • Strategic planning with DP manufacturing including defining the schedule, coordinating preparation, and troubleshooting. 
  • Client calls, interactions and meetings (kick off meeting, tours, and operational issues).                        
  • Internal investigations (Deviations, Corrective Actions, Preventative Action, Product Quality reviews).                                      
  • Facility planning (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 Ajinomoto Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

 

Requirements :

  • Bachelor’s degree in scientific discipline or equivalent experience required.
  • Minimum of seven (7) years of related technical experience. Minimum of three (3) year of leadership/supervisory experience.
  • Understanding of cGMP's.   
  • Understanding of regulatory requirements. 
  • Solid command of chemistry including understanding of formulations and processes regarding formulations. 

 

Supervisory Responsibilities :

  • Directs and provides expert knowledge in the day-to-day function of Drug Product Manufacturing-Formulations.
  • Identifies, recruits, and retains top-notch talent.
  • Champions Ajinomoto 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 Ajinomoto Bio-Pharma’s policies and procedures.

 

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.

 

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.