Lyophilization Specialist
San Diego, CA 
Posted 3 days ago
Job Description

Why join Ajinomoto Bio-Pharma?

Our mission is to help improve the health of humankind.

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.

Total Rewards package designed to make your life better:

We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

We are currently seeking a Lyophilization Specialist who will work within the Drug Product manufacturing group as the subject matter expert to commission new freeze dryers, assist and/or implement new and existing client projects, train staff, and drive continuous improvements for processes and equipment related to lyophilization of parenteral products.


  • Interacts with clients to ensure successful technical transfer and integration of lyophilization processes into Aji Bio-Pharma's manufacturing operations.
  • 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 staff on equipment and procedures associated with lyophilization.
  • Coordinates and oversees the lyophilization-related activities of cross-functional departments and teams to successfully complete projects.
  • Assists with re-qualification and validation of equipment and procedures
  • Assists equipment specialist in the routine maintenance of production equipment as needed.
  • Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
  • 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.
  • Embodies Aji Bio-Pharma's cultural values and aligns daily actions with department goals and company culture.


  • Bachelor's degree in Life Science discipline or equivalent required.
  • Minimum of 2 - 7 years of relevant experience in a parenteral manufacturing environment with at least 2 - 4 years in lyophilization.
  • Must have experience operating and troubleshooting automated lyophilization, compact loading/unloading system, SKAN Isolators 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.
  • 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.
  • Proven ability 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.

The anticipated salary range for candidates who will work in California is $60,456 to $84,639.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states.

If you meet the requirements above, and would like to apply for this position, please visit our website at and click on the "Careers" section. Please be sure to note where you saw our ad posting.

New hires will 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


"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."


Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
2 to 7 years
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