Drug Product Manufacturing Associate - ADC

Location
92121, San Diego
Posted
May 22, 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 Drug Product Manufacturing Associate responsible for implementation of production and manufacturing processes to produce Biologics in a cGMP compliant environment.

 

This position is specifically focused on HPAPI and ADC manufacturing and features isolator technology.

 

 

Responsibilities:

  • Performs various semi-routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations.
  • Acts as the lead in daily operations ensuring all components are in place, operators are trained and all documentation is complete prior to finishing a campaign.
  • May act as subject matter expert for manufacturing equipment.        
  • Schedules manufacturing tasks under cGMP guidelines and under the supervision of manufacturing supervisor.
  • Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of manufacturing supervisor.       
  • Assists in the research and implementation of new methods and technologies to enhance operations.
  • Routinely implements production and manufacturing procedures. 
  • Prepares components, media, buffers, and other solutions as needed.
  • Accurately documents data and writes/reviews batch records under cGMP guidelines.
  • Operates production equipment and may prepare buffers and media, inspect, label, or box.
  • Reliably executes and writes well defined SOP’s and manufacturing batch records. Initiates and writes revisions to current GMP/SOP guidelines.
  • Assists in the development of scalable processes with improved product yield and reduced costs for manufacturing systems.
  • Responsible for routine maintenance of production equipment and production suites.
  • Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
  • 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. Bachelor’s degree in a Life Sciences discipline or equivalent strongly preferred.
  • Minimum of four (4) years of relevant experience in manufacturing. Experience with isolator technology is preferred.
  • 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 manufacturing GMP environment.
  • Familiarity with cGMP, manufacturing, machine operations, and data entry.
  • Must be familiar with Microsoft Office applications.

 

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.