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 Drug Product Manufacturing Lyo Specialist to work within the Drug Product manufacturing group as primary Lyophilization Operator Technician. This specialist will assist and/or implement with Lyo/CLU operation, train personnel, assist/drive continuous improvements for processes and equipment related to lyophilization of parenteral products. The Drug Product Manufacturing Lyophilization Specialist I will also support with other manufacturing operations.

Responsibilities:

• Responsible for the execution of the day-to-day responsibilities for Line 1 production
• Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility.
• Operates the Lyo and CLU Equipment
• Provides technical support to manufacturing staff within area of specialty.
• Reviews SOPs and other technical and quality related documentation.
• Employs technical knowledge to investigate matters related to lyophilization equipment and processes.
• Supports continuous improvement to existing equipment and process procedures to enhance safety, quality and productivity.
• Trains personnel on equipment and procedures associated with lyophilization and the CLU.
• Help Coordinate activities of cross functional departments (Manufacturing, Metrology, Validation and Quality).
• Assists with re-qualification and validation of equipment and procedures
• Assists equipment specialist in the routine maintenance of production equipment as needed.
• Accurately documents data and writes/reviews batch records under cGMP guidelines.
• Prepares material components for production.
• 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.
• Interacts with clients to ensure successful technical transfer and integration of lyophilization processes into Althea’s manufacturing department.
• Interact with client and serve as lyophilization/Line 1 point of contact

Requirements:

• High school diploma required. Bachelors in a science or engineering discipline preferred.
• Minimum of five (5) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions or equivalent.
• Ability to work with cross functional teams.
• Must have experience operating and troubleshooting lyophilization, tray loading/unloading, and vial handling equipment.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
• Must have good knowledge of cGMP, manufacturing, machine operations, and data entry.
• Must be familiar with Microsoft Office applications.
• Demonstrated knowledge and experience with low temperature rotary screw refrigeration systems, lyophilizer vacuum systems, and the instrumentation associated with routine lyophilizer performance monitoring, functional control, and qualification activities
• Must be able to develop solutions to problems that require ingenuity, creativity, and innovativeness.
• Understand and apply complex technical concepts to manufacturing/production methodology.

The anticipated salary range for candidates who will work in California is $28.25- $39.56

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

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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