Drug Substance Associate III - Upstream
Let’s Make Things Happen!
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.
Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.
Althea is currently seeking a Drug Substance Associate III - Upstream responsible for executing various Upstream GMP manufacturing tasks. This position works alongside experienced upstream team members and will become proficient with fermentation and TFF (UF/DF) systems employed during manufacturing campaigns. Builds sound working relationships with internal departments and external clients in support of company goals. Compliance with established Good Manufacturing (GMP) procedures, safety, and regulatory regulations is required.
- Responsible for the execution of the day-to-day Drug Substance Manufacturing Upstream group operations. Proactively assumes responsibility for upstream tasks.
- Performs various routine upstream GMP manufacturing tasks under the guidelines of Althea’s 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.
- May be responsible for troubleshooting and resolving upstream manufacturing issues.
- May be responsible for project coordination (to include but not limited to documentation, materials, suite and equipment readiness, QC and QA support, executed batch record review).
- Cross trains with process sciences and/or downstream manufacturing groups as needed in support of company goals.
- Responsible for the operation and maintenance of fermenters, continuous centrifuge, homogenizers, and TFF systems during manufacturing campaigns.
- Responsible for and may train on client/audit tours of GMP fermentation areas.
- Responsible for the interaction with Project Management QA, QC, Facilities, Engineering, Process Sciences, GMP production groups and external clients regarding fermentation campaigns.
- May be responsible for in the initiation and authoring of upstream related deviations and preventative actions, to include root cause analysis, technical assessment, and corrective action.
- 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.
- Embodies Althea’s cultural values by aligning daily actions with department goals and company culture.
- High School Diploma or equivalent required. Bachelor’s degree in a life sciences discipline or equivalent preferred.
- 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, or as a team member.
- Ability to follow detailed directions in a manufacturing GMP environment.
- 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.altheacmo.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
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.