Drug Product Manufacturing Associate – Formulations

Let’s Make A Difference!

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

Every team member at Ajinomoto Bio-Pharma Services, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing andaseptic drug product fill in vials and syringes.

We believe our people are the greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come. If you enjoy working in a fast-paced, inspiring, and values-driven culture, Ajinomoto Bio-Pharma Services is the place for you.

Together, Let’s Make A Difference.

Ajinomoto Bio-Pharma Services is currently seeking a Drug Product Manufacturing Associate – Formulations to contribute their technical expertise!

The Drug Product Manufacturing Associate - Formulations is responsible for the implementation of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements. The Associate will work with the Drug Product team to ensure the successful completion of various cGMP activities. The Associate will optimize processes and achieve the subject matter expert status on both technical aspects as well as with quality systems which govern cGMP manufacturing.    

Responsibilities:

• Performs various manufacturing tasks including sterile filtration, formulation, in-process testing, and preparation of formulation components, and product development project preparations in accordance to established Standard Operations Procedures (SOP’s) and cGMP regulations.  
• Support with the implementation of production and manufacturing procedures and schedules. 
• Effectively assist other technical personnel on issues and problems that may arise during shift.
• Initiates revisions to current Master Production Records, SOPs and department desktop aides.
• Supports the management of group production resources and product development projects.
• Expected to operate production equipment including TFF system, Rotavap, Microfluidizer, Homogenizer, chiller, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven and CIP system.
• Maintains and qualifies aseptic bulk production operations in GMP production facilities containing over 27,000 square ft. of Grade A, B, C, and D clean room manufacturing areas.
• Supports routine maintenance and troubleshooting of production equipment.
• Accurately documents, completes, and reviews batch records, as needed.
• Coordinates and leads preparation of material and components for sterilization in autoclave or dehydrogenation oven.
• Collaborates with other technical personnel with troubleshooting and engineering activities.
• Collects and disposes of lab wastes according to established Safety, Health, and Environment (SHE) procedures.
• Maintains cGMP environment according to the production needs of the Drug Product group.
• May be required to interact and collaborate with clients and third party vendors.
• Works closely with Production Planner to manage QAD work orders to ensure production materials are obtained according to the manufacturing schedule.
• 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 :

• High School Diploma required. Bachelor’s degree in a life sciences discipline or equivalent preferred.
• Minimum of four (4) years of relevant experience in a manufacturing or laboratory environment.
• 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.
• Familiarity with cGMP, manufacturing, machine operations, and data entry.
• 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.ajibio-pharma.com and click on the "Careers" section.  Please be sure to note where you saw our ad posting.

Successful candidate must 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.

Qualified M/F/D/V candidates are encouraged to apply.