Drug Substance Investigator

Location
92121, San Diego
Posted
Jan 31, 2019
Required Education
Bachelors Degree
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 andaseptic 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 Ajinomoto Bio-Pharma Services currently seeking a Drug Substance Investigator responsible for implementation of routine production and manufacturing procedures to optimize processes and regulatory requirements.

 

Responsibilities:

  • Under minimal supervision, initiates and supports through completion the timely investigations and resolution of issues related to drug substance manufacturing. 
  • Becomes familiar with upstream, downstream, and support services equipment, Althea's production facility, systems, and technologies to facilitate the accurate completion of responsibilities. 
  • Supports and may participate (for background knowledge) with upstream, downstream, and support service teams. 
  • Under direct supervision, authors and revises compliance, change controls, and other technical documentation. 
  • Assists with tracking and trending documentation and data as specified. 
  • May be responsible for the timely submission of executed batch records to manufacturing review. 
  • May provide support to internal and client audits as needed.
  • 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.

 

Requirements:

  • Bachelor's degree in a life science discipline or equivalent required.
  • Minimum of two to four (2-4) years of relevant experience in documentation, cGMP manufacturing, biology, quality assurance, or equivalent experience.
  • Previous experience with investigations is preferred. 
  • Previous experience writing technical documentation (SOPs, preventative actions, deviations, reports) preferred. 
  • Minimum one (1) year of experience in cGMP environment required. Emphasis on upstream or downstream processing and compliance preferred. 
  • Clean room gowning experience and mechanical aptitude are a plus. 
  • Ability to proactively assume responsibility for completing investigation tasks. 
  • Ability to build sound working relationships with internal departments and external clients in support of company goals.
  • Commits to working in a team environment in support of the drug substance manufacturing investigation group.
  • Must have solution based attitude. 
  • Strong listening and interpretive skills to successfully translate events into clearly written documents. 
  • Detail oriented with very strong English writing skills. 
  • Strong verbal communication skills. 
  • Ability to work independently, within prescribed guidelines, or as a team member. 
  • Must be highly proficient 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.