Supervisor, Drug Product Manufacturing - ADC

Location
San Diego, California
Posted
Jun 12, 2018
Required Education
High School or equivalent
Position Type
Full time

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

 

This role is dedicated to Althea’s newest facility with a focus on aseptic fill & finish operations for ADC and high potency products. The ideal candidate will have previous experience with linear filling equipment and isolator technology.

 

Responsibilities :

  • Oversees and schedules production operations and personnel within cGMP guidelines. May supervise operations within a class 100 area.
  • Interacts and communicates with clients regarding production. Troubleshoots complex manufacturing process problems and issues.
  • Coordinates with multiple departments including Microbiology and Quality on production deliverables.
  • Trains employees in production methods, cGMP guidelines, and SOP’s.
  • Writes deviations, OOS and any other investigations pertaining to the group.
  • Organizes a weekly schedule for operations utilizing all of the employees in the group for operations.
  • Works with Management to implement process improvements, trainings, new projects and facility repairs.          
  • Writes batch records and writes/revises SOP’s pertaining to production processes.
  • Drafts, reviews, revises, and executes batch records, validation protocols, and reports.
  • Researches and implements new methods and technologies to enhance operations.
  • Responsible for maintenance of production equipment.
  • 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.

 

Requirements :

  • High School Diploma or equivalent required; Bachelor’s degree preferred.
  • Minimum of five (5) years of relevant experience in a manufacturing or laboratory environment.
  • Minimum of one to three (1-3) years of leadership/supervisory experience.
  • Experience with cGMP, manufacturing, machine operations, and data entry.
  • Experience with isolator technology preferred.
  • Detail oriented with strong verbal and written communication skills.
  • Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • Familiarity with Microsoft Office applications.

 

Supervisory Responsibilities :

  • Leads and provides expert knowledge in the day-to-day function of the Drug Product Manufacturing - ADC group.
  • Identifies, recruits, and retains top-notch talent.
  • Coaches, mentors, engages and develops the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
  • Champions Althea’s culture and empowers employees to take responsibility for their jobs and goals.

 

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.