Sr. Process Development & Tech Transfer Associate I - ADC

Location
92121, San Diego
Posted
Mar 20, 2018
Required Education
Bachelors Degree
Position Type
Full time

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. Process Development & Tech Transfer Associate I - ADC responsible for the process development, technical transfer and implementation of manufacturing processes for antibody drug conjugates (ADC) and highly potent protein products (HPP).

 

Responsibilities:

  • Participates in tech transfer activities, including contributing to process descriptions, assisting in batch-record generation, preparing technology transfer protocols, compiling project reports and delivering presentations.
  • Conducts experiments in ADC Process Development laboratory and accurately documents procedures and results in laboratory notebook. This will include ADC conjugation reactions, ultrafiltration/diafiltration, column chromatography, filtration operations and pre-formulation studies.
  • Works on projects involving research, innovation and process improvements.
  • Performs DOE, carries out experiments, data analysis, and prepares results summaries.
  • May attend client meetings and present experimental results and data summaries as required.
  • Completes analytical testing as needed to support ADC process development activities.
  • Responsible for preparing reagents, components, media, buffers, and other solutions as needed, including the handling of highly potent ADC drug-linkers.
  • May be responsible for preparing training documentation and presentations for new methods and technologies to enhance operations.
  • Provides technical support for GMP personnel in the implementation of new and modified processes.
  • Responsible for completing SOP and GMP training, and adhering to GMP policies and procedures with exceptional attention to detail.
  • May cross-trains on various tasks including upstream and downstream GMP manufacturing, as required.
  • May be responsible for authoring and/or reviewing GMP-related documents such as material specifications, buffer batch records, and deviation reports, as required.
  • May be responsible for training GMP personnel in the implementation of new production and manufacturing procedures.
  • Embodies Althea’s cultural values and aligns daily interactions with departmental goals and company culture.

Requirements:

  • Bachelor’s degree in a Life Sciences discipline required; Master’s degree preferred. 
  • Minimum of six (6) years of relevant experience in ADC research, process development or manufacturing.
  • Experience with common ADC conjugation techniques and proven track record thereof.
  • Experience using pilot and production scale chromatography, TFF and UF/DF systems preferred.
  • Knowledge of AKTA-based protein purification and HPLC-based protein analysis.
  • Detail oriented with strong written and verbal communication skills.
  • Ability to work independently within prescribed guidelines and as a member of a multi-functional team.
  • Ability to follow detailed directions in a manufacturing GMP environment.
  • Familiarity with cGMP, manufacturing, and data entry.
  • Must be familiar with Microsoft Office applications and common DOE software (JMP).

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.