Sr. Lyophilization Specialist

Location
92121, San Diego
Salary
DOE
Posted
Jan 03, 2018
Required Education
Bachelors Degree
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 Sr. Lyophilization Specialist to join the Drug Product Manufacturing group as the subject matter expert to implement new and existing client projects, train personnel, and drive continuous improvements for processes & equipment related to lyophilization of parenteral products.

 

Responsibilities:

  • Interacts with clients to ensure successful technical transfer and integration of lyophilization processes into Althea’s manufacturing department.
  • Provides technical and theoretical support to manufacturing staff within area of specialty.
  • Writes and reviews SOPs, compliance, change controls, risk assessments and other technical and quality related documentation.
  • Employs high level technical expertise to investigate and resolve complex matters related to lyophilization equipment and processes.
  • Responsible for continuous improvement to existing equipment and process procedures to enhance safety, quality and productivity.
  • Researches and implements new equipment, methods and technologies for the lyophilization of parenteral products.
  • Trains others on equipment and procedures associated with lyophilization.
  • Coordinates & oversees the activities of all cross functional departments (Manufacturing, Metrology, Validation and Quality) to successfully complete all projects.
  • Assists with re-qualification and validation of equipment and procedures.
  • Assists equipment specialists in the routine maintenance of production equipment as needed.
  • 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:

  • Bachelor’s degree in Life Science discipline or equivalent.
  • Minimum of eight (8) years of relevant experience in a parenteral manufacturing environment with at least five (5) years in lyophilization.
  • Experience operating and troubleshooting automated lyophilization, tray loading/unloading, and vial handling equipment.
  • Extensive knowledge of the processes and qualification for CIP, SIP, vacuum integrity testing, media simulation and parenteral lyophilization.
  • Demonstrated knowledge and experience with low temperature rotary screw refrigeration systems, lyophilizer vacuum systems, helium leak detection, and the instrumentation associated with routine lyophilizer performance monitoring, functional control, and qualification activities.
  • Experience with lyophilizer loading/unloading using RABS and full isolator environmental barriers.
  • Demonstrated ability to understand and apply complex technical concepts to manufacturing/production methodology.
  • Must have a high level of knowledge in global pharmaceutical cGMP’s.
  • Must be able to develop solutions to complex problems that require an in-depth degree of ingenuity, creativity, and innovation.
  • Detail oriented with strong written and verbal communication skills.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • 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.

 

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.