Position Description

Drug Substance Manufacturing Assistant - Support Services
Location San Diego, CA
Department BMG Manufacturing - 510
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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.

 

Ajinomoto Bio-Pharma Services is currently seeking a Drug Substance Manufacturing Assistant - Support Services responsible for performing solution formulation and/or sterilization of in-process manufacturing materials in support of cGMP manufacturing under the guidelines of established SOP's and cGMP regulations.

 

Responsibilities:

  • Transfers raw materials from warehouse staging area to production suite, labels materials for applicable client use.
  • Conducts inventory and storage of raw materials in production area.
  • Prepares components, buffers and other solutions and/or operates autoclave, washer, or depyrogenation oven.
  • Completes in-process analytical testing as needed to confirm suitability of solutions and submits samples to QC for release testing via LIMS system.
  • Accurately documents data and completes batch records and GMP forms.
  • Under supervision, operates production equipment (pH/conductivity meters, mixers, pumps, sterilization units, forklift).
  • Adheres to all established GMP, safety, and regulatory policies and procedures with high focus on attention to detail.
  • Completes all job related, mandatory read-understood and qualified GMP training tasks within MasterControl (Quality System Software).
  • Collects and disposes of lab wastes per established procedures.
  • Listens attentively to internal departments and team members to relay support services information, responsibilities, and policies respectfully, effectively, and clearly.
  • Builds sound working relationships with internal departments and external clients in support of company goals.
  • Commits to working in a team environment in support of the drug substance manufacturing support services group.

 

Requirements:

  • High School Diploma or equivalent experience required.
  • Zero to two (0-2) years of relevant experience in a manufacturing or laboratory environment.
  • Detail oriented with strong written and verbal communication skills.
  • Knowledge of GLP and cGMP regulations and good documentation practices is preferred.
  • Ability to work within prescribed guidelines or as a team member.
  • Strong organizational and analytical skills.
  • 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
  • Annual Company Shutdown in December
  • Comprehensive Medical, Dental + Vision
  • 401K Company Match + Immediate Vesting
  • Backup Daycare and Eldercare
  • Monthly Employee Appreciation Events and Food Truck Fridays
  • 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.

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

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