Executive / senior industry position
Ajinomoto Bio-Pharma Services is currently seeking a Drug Substance Manufacturing Associate III – Upstreamto support Ajinomoto Bio-Pharma Services’ manufacturing. This position is responsible for executing the day to day responsibilities related to the Drug Substance Manufacturing Upstream group under the guidance of Aji Bio-Pharma’s established procedures and policies. The position works with senior and junior team members in support of the technical transfer and integration of processes into the Drug Substance Manufacturing Upstream department. The position executes fermentation, harvest, continuous centrifugation, homogenization, and TFF (UF/DF) operations during manufacturing campaigns. The position aligns daily actions with company goals and cultural values.
- Performs various routine upstream GMP manufacturing tasks under the guidelines of Aji Bio-Pharma’s established policies and procedures with high focus on attention to detail.
- Performs job related and mandatory read and understood, and qualified GMP training tasks within MasterControl (Quality System Software).
- Uses industrial equipment (to include but not limited to forklift and pallet jack).
- Accurately documents data and executes master batch records.
- Requires no supervision to operate fermenters, continuous centrifuge, homogenizers, CIP carts, and TFF systems and can work independently on applicable assigned tasks.
- May be responsible for project leading upstream campaigns.
- May assist in upstream project coordination (to include but not limited to documentation, materials, suite and equipment preparedness, QC and QA support, executed batch record review, and interact with the project management group).
- May assist in troubleshooting upstream manufacturing issues.
- Assists in authoring and/or revising SOPs or production batch records.
- Collects upstream process data for metrics/data trending.
- May train junior team members.
- 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.
- Minimum of four (4) years of experience in upstream biologics manufacturing.
- Detail oriented with strong written and verbal communication skills.
- Ability to work within prescribed guidelines, as a team member, or independently on applicable projects.
- Ability to follow detailed directions in a manufacturing GMP environment is preferred.
- Familiarity with cGMP, manufacturing, fermentation, 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.
Qualified M/F/D/V candidates are encouraged to apply.