Drug Product Manufacturing Associate – Formulations

Location
92121, San Diego
Posted
Mar 19, 2018
Discipline
Science/R&D
Required Education
High School or equivalent
Position Type
Full time

Ajinomoto Althea is currently seeking a  Drug Product Manufacturing Associate – Formulations. This position is responsible for implementation of routine production and manufacturing procedures to optimize processes and regulatory requirements.

 

Responsibilities:

  • Performs various routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations.                                                  
  • Implements production and manufacturing procedures. 
  • Performs visual inspection.
  • Prepares components, media, buffers, and other solutions as needed.
  • Accurately documents data and completes batch records as needed.
  • May cross train and/or focus in various manufacturing tasks including fill/finish, formulation, fermentation, preparation.
  • Operates production equipment and may prepare buffers and media, inspect, label, or box..
  • Reliably executes well defined SOP’s.
  • Assists other technical personnel on issues and problems.
  • Initiates revisions to current GMP/SOP guidelines.
  • Collects and disposes of lab wastes according to established procedures.
  • Responsible for routine maintenance of production equipment.
  • Operates TFF system, Rotavap, chiller, Microfluidizer, Homogenizer, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven and CIP system.
  • Maintains and qualifies aseptic bulk production operations in GMP production facilities containing over 27,000 square ft. of Grade A, B, C, and D clean room manufacturing areas.
  • 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 required. Bachelor’s degree in a life sciences discipline or equivalent preferred.
  • Minimum of four (4) years of relevant experience in a manufacturing or laboratory environment.
  • 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.

Ajinomoto Althea, located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the experience, expertise, capacity, and flexibility to serve as a strategic partner for drug development and manufacturing needs for early stage and commercial requirements.

 

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.

Althea is an EOE dedicated to a diverse work force and Drug Free Work Environment.

Qualified M/F/D/V/ candidates are encouraged to apply.

 

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