Drug Substance Manufacturing Associate II – Downstream

Location
92121, San Diego
Posted
Oct 02, 2018
Required Education
High School or equivalent
Position Type
Full time

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 and aseptic 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 Substance Manufacturing Associate II – Downstream responsible for executing the day to day responsibilities related to the Drug Substance Manufacturing Downstream group, under supervision. The position works under the guidance of experienced downstream team members in support of the successful technical transfer and integration of processes into the Drug Substance Manufacturing Downstream department.  The position will become proficient with chromatography and TFF (UF/DF) systems employed during manufacturing campaigns.  Compliance with established Good Manufacturing (GMP) procedures, safety, and regulatory regulations is required.  The position aligns daily actions with company goals and Ajinomoto Bio-Pharma Services’ cultural values.

Responsibilities:

  • Proactively assumes responsibility for downstream tasks.
  • Performs various routine downstream GMP manufacturing tasks under the guidelines of Ajinomoto Bio-Pharma Services’ established policies and procedures with high focus on attention to detail.          
  • Completes all job related, mandatory read and understood and qualified GMP training tasks within MasterControl (Quality System Software), trains junior team members, and may develop and implement department training initiatives.
  • Builds sound working relationships with internal departments and external clients in support of company goals.
  • Listens attentively to internal departments and can relay downstream information, responsibilities and policies respectfully, effectively, and clearly.
  • May assist in troubleshooting and resolving downstream manufacturing issues.
  • May assist in project coordination (to include but not limited to documentation, materials, suite and equipment readiness, QC and QA support, executed batch record review).
  • Prepares components, buffers, and other solutions as needed.
  • May cross train with process sciences and/or upstream manufacturing groups as needed in support of company goals.
  • With little to no supervision, interfaces with Unicorn software in regards to chromatography bioprocessing systems.
  • With little to no supervision, operates industrial equipment (to include but not limited to forklift and pallet jack).
  • May assist with client/audit tours of GMP purification areas.
  • Interacts with Project Management QA, QC, Facilities, Engineering, Process Sciences, GMP production groups and external clients regarding purification campaigns.
  • Accurately documents data and executes master batch records.
  • Responsible for operating downstream production equipment.
  • May assist in the initiation and authoring of downstream related deviations and preventative actions, to include root cause analysis, technical assessment, and corrective action.
  • Collects and disposes of lab wastes according to established procedures.
  • May assist in training junior members regarding core purification functions (to include but not limited to policies, procedures, equipment, facility, and safety aspects).
  • Responsible for routine maintenance of downstream production equipment.
  • 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.
  • Displays initiative and a focus on self-development as well as departmental policies and procedures.
  • Commits to working in a team oriented environment in support of the drug substance manufacturing downstream group.
  • Supports, encourages, and collaborates with others, especially in difficult and high pressure situations.

Requirements:

  • High School Diploma or equivalent required. Bachelor’s degree in a life sciences discipline or equivalent preferred.
  • Minimum of two (2) years of experience in downstream biologics manufacturing.
  • Detail oriented with strong written and verbal communication skills.
  • Ability to work within prescribed guidelines, or as a team member.
  • Ability to follow detailed directions in a manufacturing GMP environment is preferred.
  • Familiarity with cGMP, manufacturing, machine operations, and data entry is preferred.
  • 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.