Drug Product Manufacturing Associate I - Formulations

Company: Althea Ajinomoto Inc
Location: San Diego
Posted on: March 20, 2023

Job 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 Formulations Manufacturing Associate I who is responsible for execution of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements. The Manufacturing Associate I will work with the Drug Product team to ensure the successful completion of various cGMP activities. The Manufacturing Associate I will learn and demonstrate proficiency in both the technical aspects as well as the quality systems which govern cGMP manufacturing.
Responsibilities:

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• Under the guidance of senior manufacturing operators, performs various routine manufacturing tasks while adhering to the guidelines of established Standard Operating Procedures (SOP's) and cGMP regulations.
  
• Supports the implementation of production and manufacturing procedures.
  
• Performs visual inspection of tanks and bulk drug substances.
  
• Prepares components, media, buffers, and other solutions as needed.
  
• Accurately documents data and completes batch records as needed.
  
• May cross train and/or focus in various manufacturing tasks including sterile filtration, formulation, in-process testing, and preparation of formulation components.
  
• Expected to perform manufacturing operations in a sterile suite.
  
• Preparation of material and components for sterilization in autoclave or dehydrogenation oven.
  
• Reliably executes well-defined SOP's.
  
• May be required to revise SOP's according to investigation or audit findings.
  
• Assists other technical personnel with troubleshooting and engineering activities.
  
• Collects and disposes of lab wastes according to established Environmental Health & Safety (EHS) procedures.
  
• Responsible for routine maintenance of production equipment.
  
• Maintains cGMP environment according to the production needs of the Drug Product group.
  
• 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.
    
  • Zero to two (0-2) years of relevant experience in manufacturing, laboratory, mechanical or engineering.
    
  • 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, preferably in a scientific or manufacturing environment.
    
  • Familiarity with cGMP, manufacturing, machine operations, and data entry is preferred.
    
  • Must be familiar with Microsoft Office applications.
    
    The anticipated hourly range for candidates who will work in California is $18.05 to $25.27.
    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.
    

Keywords: Althea Ajinomoto Inc, San Diego , Drug Product Manufacturing Associate I - Formulations, Other , San Diego, California