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 annual performance bonus, paid time off, paid parental leave, matching 401k contributions (immediate vesting), employee discount program and much more!

Your next career move:

We are currently seeking an Analytical Technologies Associate II. The Associate II optimizes, qualifies/validates, and transfers analytical methods to support drug product and drug substance manufacturing and fill-finish including release and stability testing. The Associate II captures testing and development data in an electronic lab notebook and test forms while maintaining compliance and data integrity standards. The Associate II will expand their knowledge and experience in ICH, GDP, GMP and regulatory guidelines on method, qualification, validation and technical writing. Mastery of at least 1 moderate and 1 routine analytical method. The expectation is that the Associate II is able to troubleshoot some instruments and method issues with guidance and leverage from Sr. members and vendors, to keep projects on track

Responsibilities:

• Performs analytical method optimization/qualification validation/transfer
• Mastery of at least 1 moderate and 1 routine analytical methodology (moderate to complex i.e., ELISA and U-HPLC concentration methods)
• Interacts with Quality Control, Process Science, Project Management, and Clients in preparation of validating the different analytical methods needed for the Drug Product Release and stability testing.
• Develops Validation Protocols in accordance with international recognized guidelines (ICH, FDA, Ph. Eur., and USP).
• Calculates, reviews, and summarizes the analytical test results in Validation Reports.
• Plans and coordinates the validation/qualification activities including Validation Strategy, required Specifications, qualification protocols/reports, and Impact / Risk Assessments.
• Reviews and approves change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.
• Demonstrates knowledge of existing QMS for authorship, review and approval of assessments, Change controls and Deviations.
• Possesses knowledge and familiarity of LIMS systems (Thermo LIMS) and ACE
• Supports optimization of test procedures to improve efficiency whenever possible.
• Support technical investigations for cGMP investigations including OOS, Change Controls CAPAs product impacting deviations.
• 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.

Requirements:

• Performs analytical method optimization/qualification validation/transfer
• Mastery of at least 1 moderate and 1 routine analytical methodology (moderate to complex i.e., ELISA and U-HPLC concentration methods)
• Interacts with Quality Control, Process Science, Project Management, and Clients in preparation of validating the different analytical methods needed for the Drug Product Release and stability testing.
• Develops Validation Protocols in accordance with international recognized guidelines (ICH, FDA, Ph. Eur., and USP).
• Calculates, reviews, and summarizes the analytical test results in Validation Reports.
• Plans and coordinates the validation/qualification activities including Validation Strategy, required Specifications, qualification protocols/reports, and Impact / Risk Assessments.
• Reviews and approves change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.
• Demonstrates knowledge of existing QMS for authorship, review and approval of assessments, Change controls and Deviations.
• Possesses knowledge and familiarity of LIMS systems (Thermo LIMS) and ACE
• Supports optimization of test procedures to improve efficiency whenever possible.
• Support technical investigations for cGMP investigations including OOS, Change Controls CAPAs product impacting deviations.
• 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.

The anticipated hourly range for candidates who will work in California is $27.66 - $36.31

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 www.ajibio-pharma.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.

New hires will be asked to complete a background check and drug screen as a condition of employment.

For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO

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.

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