Manager, Drug Product Inspection

Location
92121, San Diego
Posted
Apr 17, 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 Inspection. The Manager, Drug Product Inspection manages groups responsible for all aspects related to visual inspection and clinical labeling / packaging operations.  This position is responsible for implementation of all procedures as they relate to inspection operations to comply with regulatory requirements and also to coordinate the planning, scheduling, and execution of operations with other departments.

 

The position oversees the training and qualification program for visual inspection operators and directs investigations as they relate to visual inspection operations.  The Manager is responsible for continuous process improvements. It is expected the Manager will participate in regulatory and client interactions.

 

 

 

Responsibilities:

 

  • Oversees and schedules production operations and employees within cGMP guidelines.
  • Interacts with clients and manufacturing to assure successful technical transfer and integration of visual inspection, packaging and labeling processes into the manufacturing department.
  • Manages and facilitates interactions and communications with internal and external client stakeholders regarding production.
  • Interacts with potential clients, client auditors and regulatory bodies as a visual inspection and cGMP subject matter expert.
  • Manages cGMP manufacturing activities including document production and review, internal and external driven continuous improvement projects, and assurance of cGMP compliance across all facilities.
  • Troubleshoots manufacturing process problems. Leads the team to identify issues and propose adequate solutions.
  • Provides technical support to manufacturing and investigations staff within areas of specialty.
  • Employs high level technical expertise to develop new processes and creatively solve problems.
  • Oversees reviews and approves inspection protocols, SOPs, forms, and study reports. 
  • Responsible for continuous employee training, education and coordinating guest speakers and seminars.
  • Responsible for automated cap coding and inspection systems.
  • Responsible for producing group metrics, analyzing results and presenting conclusions to senior manufacturing management.
  • Researches and implements new methods and technologies to enhance operations. Suggests improvements to existing methods and procedures.
  • 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 Services’ cultural values and aligns daily actions with department goals and company culture.

 

Requirements:

 

  • Bachelor’s degree in a life sciences discipline or equivalent training and experience required.
  • Minimum of five (5) years of relevant experience in a cGMP manufacturing, laboratory or other applicable regulated environment.
  • Minimum of two (2) years of visual inspection experience or equivalent experience.
  • Minimum of three (3) years of leadership/supervisory experience.
  • 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 proficient with Microsoft Office applications.
  • Leadership Responsibilities:
  • Directs and provides expert knowledge in the day-to-day function of Drug Product Inspection.
  • Identifies, recruits, and retains top-notch talent.
  • Champions Ajinomoto Bio-Pharma Services’ 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 Services’ 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.