Process Engineer - Complex Formulations
Althea Technologies - San Diego, CA

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Althea Technologies is currently seeking a Process Engineer in our Complex Formulations Department. This position advises the groups responsible for cGMP contract manufacturing of large scale plasmid DNA production and lyophilization programs. The Process Engineer works directly with clients’ process development and project management groups to ensure successful technical transfer and integration of processes into Althea’s Complex Formulations Department.

Responsibilities:

  • Oversees large-scale plasmid production and plasmid process development or formulation production and formulation process development.
  • Oversees lyophilization programs including implementation and tech transfers.
  • Implements complex production and manufacturing procedures and optimizes processes.
  • Responsible for scale-up and troubleshooting of manufacturing processes.
  • Develops scalable processes with improved product yield and reduced costs for manufacturing systems.
  • Researches and implements new methods and technologies to enhance operations. Suggests improvements to existing methods and procedures.
  • Produces complex, high-level materials using established procedures and protocols.
  • Writes and reviews SOPs and validation protocols for manufacturing equipment. Leads the development and implementation of improved fermentation and processing methods for scale up of cGMP manufacturing. Initiates revisions to current GMP/SOP guidelines
  • 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.

Requirements:

  • Bachelor’s degree in a Life Sciences discipline or equivalent.
  • Six to eight (6-8) years of relevant experience in manufacturing.
  • Demonstrated ability to understand and apply complex technical concepts to manufacturing/production methodology.
  • Detail oriented and strong written and verbal communication skills.
  • Demonstrated ability to follow detailed directions in a laboratory environment.
  • Must be familiar with Microsoft Office applications.

Althea Technologies, 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.atheatech.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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