Drug Product Manufacturing Associate III - Formulations
San Diego, CA 
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Posted 26 days ago
Job Description

Together, 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, 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 and aseptic drug product fill in vials and syringes.

We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.

Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.

We are currently seeking a Drug Product Manufacturing Associate III - Formulations who 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 and achieve the subject matter expert status both technical aspects as well as quality systems which governs 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.

We provide a Total Rewards package designed to make life better - both at work and at home.

  • Annual Bonus Opportunities for All Employees
  • 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
  • Paid Parental Leave
  • Annual Company Shutdown in December
  • Comprehensive Medical, Dental + Vision
  • 401K Company Match + Immediate Vesting
  • Backup Daycare and Eldercare
  • Employee Appreciation Events
  • Employee Discount Programs
  • Tuition Reimbursement
  • Casual Dress Code
  • Wellness Programs
  • Community Outreach Opportunities

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 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.

Please be advised that Aji Bio-Pharma follows a comprehensive set of recruiting protocols and conducts interviews either in person or phone/via live video only. We will never use apps like RingCentral or other chat features to conduct an interview. The scammer is using an email account that looks like an Ajinomoto account but ending in .work in an attempt to fool individuals. We strongly recommend ignoring any request that looks suspicious or is unexpected. DO NOT CLICK ON ANY LINKS or provide any information in response to these scams. Please contact us at with any questions.

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"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
High School or Equivalent
Required Experience
4 years
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