Sr. Microbiology Associate II

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 Sr. Microbiology Associate II who is responsible for supporting manufacturing operations at Ajinomoto Bio-Pharma Services, as well as providing technical microbiological and regulatory support to the QC Microbiology team. The Sr. Microbiology Associate II may focus in a specialized area and is expected to provide microbiological testing expertise, conduct high level investigations, conduct and improve test methods while maintaining compliance, and perform qualifications in accordance with standard operating procedures.

This position will comply under GMP standards while practicing quality excellence and maintaining Aji Bio-Pharma cultural values of Customer Focus, Innovation, Accountability, Communication, Compliance, and Teamwork.

Responsibilities:

• Has a deep understanding of the regulations and ability to apply to internal procedures with minimal oversight.
• Leads complex product investigation and corrective actions cross functionally.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors (CapEx projects, LIMS validation of electronic data, audit corrections).
• Knowledge with application of statistics and understanding of specification setting and establishment of acceptance criteria.
• Identify and recommend any change as an opportunity to improve business performance and campaign for it when necessary.
• Act as an subject matter expert of environmental monitoring and/ or microbiology lab activities.
• Prepares method qualification protocols & reports and performs qualification testing.
• Reviews and approves data and trend reports.
• Responds to client questions and participates in client-facing activities.
• Serves as departmental representative on cross-functional teams.
• Independently conducts studies and special projects for process improvements.
• Responsible for the implementation of departmental continuous improvement and cost-savings measures.
• Authors SOPs, OOS, deviations, trend reports, excursion reports and other quality system reports, as required.
• Expert/ SME applying data integrity, 21CFR compliance to issues or questions that arise.
• Trains junior analysts on microbiological methods per applicable test method.
• Interfaces with contract labs and can interpret data.
• Reviews data obtained for compliance specifications and reports abnormalities to Manager.
• Participates in regulatory audits and inspections.
• Prepares metrics and data for internal and external meetings and presentations.
• Understands and can effectively speak to SOWs, QAGs and MSAs to drive business decisions.
• Performs troubleshooting and preventive maintenance of equipment.
• Understands and adheres to drivers behind timelines (i.e., investigation associated with lot release and revenue); understands contingency plans to keep projects on track and can identify corrections for process gaps.
• Participates in KPIs and timelines to reduce cycle times.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
• Exhibits professional behavior 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:

• Bachelor's degree strongly preferred in a Life Sciences discipline or equivalent.
• Eight to ten (8-10) years of relevant experience in a laboratory environment or equivalent.
• Extensive experience with GMP, aseptic techniques, and good cleanroom behavior preferred.
• Ability to perform testing in a highly accurate and reproducible manner.
• Proficiency with Microsoft Office applications.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.

The anticipated hourly range for candidates who will work in California is $34.12 - $44.78

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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