Sr. Drug Product Manufacturing Assistant – Formulations - San Diego, CA | Biospace
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Sr. Drug Product Manufacturing Assistant – Formulations

Ajinomoto Althea, Inc.

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Location:
San Diego, CA
Posted Date:
8/25/2017
Position Type:
Full time
Job Code:
Salary:
DOE
Required Education:
High school or equivalent
Areas of Expertise Desired:
Biotechnology, Formulation, Manufacturing, Manufacturing/Production,

Job Description

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 Sr. Drug Product Manufacturing Assistant – Formulations responsible for implementation of routine production and manufacturing procedures to optimize processes and regulatory requirements.



Responsibilities:
•Performs various routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations.                                                  
•Implements production and manufacturing procedures.  
•Performs visual inspection.
•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 fill/finish, formulation, fermentation, preparation.
•Operates production equipment and may prepare buffers and media, inspect, label, or box.
•Reliably executes well defined SOP’s.
•Assists other technical personnel on issues and problems.
•Initiates revisions to current GMP/SOP guidelines.
•Responsible for routine maintenance of production equipment.
•Operates TFF system, Rotavap, chiller, Microfluidizer, Homogenizer, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven and CIP system.
•Maintains and qualifies aseptic bulk production operations in GMP production facilities containing over 27,000 square ft. of Grade A, B, C, and D clean room manufacturing areas.
•Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
•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.

Requirements

Requirements:
•High School Diploma or equivalent required. Bachelor’s degree in a life sciences discipline or equivalent preferred.
•Minimum two (2) years of relevant experience in a manufacturing or laboratory environment.
•Detail oriented with strong written and verbal communication skills.
•Ability to distinguish one or several chromatic colors, independent of the capacity for distinguishing light and shade.
•Ability to work independently, within prescribed guidelines, or as a team member.
•Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
•Familiarity with cGMP, manufacturing, machine operations, and data entry.
•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.