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Drug Product Manufacturing Associate II - Formulations

Job Description

Description

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 Associate II - Formulations who is responsible for the implementation and execution of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements.

The Associate II will work with the Drug Product team to ensure the successful completion of various cGMP activities. The Associate II will optimize and achieve a solid understanding of both the technical aspects as well as the quality systems which govern cGMP manufacturing.

Responsibilities:

  • Performs various routine manufacturing tasks under the guidelines of established Standard Operating Procedures (SOP's) and cGMP regulations.
  • Coordinates the implementation of production and manufacturing procedures and schedules.
  • Performs visual inspection of tanks and bulk drug substances.
  • Prepares components, media, buffers, and other solutions as needed.
  • Accurately documents, completes, and reviews batch records.
  • Expected to focus in various manufacturing tasks including sterile filtration, formulation, in-process testing, and preparation of formulation components.
  • Perform manufacturing operations in a sterile suite.
  • Coordinates and leads preparation of material and components for sterilization in autoclave or dehydrogenation oven.
  • Reliably executes well defined SOP's.
  • Required to revise SOP's according to investigation or audit findings.
  • 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.
  • Responsible for routine maintenance and troubleshooting of production equipment.
  • 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.
  • Responsible for supporting the management of group production resources.
  • 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.
  • Two to five (2-5) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions.
  • 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 scientific or manufacturing environment.
  • Familiarity with cGMP, manufacturing, machine operations, and data entry is required.
  • Must be familiar with Microsoft Office applications.

The anticipated hourly range for candidates who will work in California is $23.05 - $30.25.

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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"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."


 

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