Manager, Validation

Location
San Diego, California
Posted
Jun 12, 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 Manager, Validation to provide leadership and oversight for the creation and execution of validation programs, procedures, and protocols at Althea’s newest facility.

 

This role is dedicated to Althea’s newest facility which has a focus on aseptic fill & finish operations for ADC and high potency products. The ideal candidate will have previous experience with facility commissioning and startup activities, aseptic process validation, and cleaning validation.

 

Responsibilities :

  • Ensures validation approaches are aligned with relevant guidance documents and current industry best practices.
  • Responsible for documentation preparation, review and execution for aseptic processes, process validation, equipment, utilities, and cleaning procedures.
  • Writes detailed validation reports and analyzes complex quality data.
  • Uses mathematics to solve measurement related problems as well as to derive and interpret specifications.
  • Works closely with cross-functional departments as necessary to resolve issues.
  • Oversees document deviations, system failures, investigations, and corrective actions
  • Troubleshoots and rectifies issues that are complex in nature.
  • Determines the causes of measurement errors as related to validation and calibration and present solutions to resolve them.
  • Ensures that supporting documentation and test results are formally recorded and reported; resolutions are implemented effectively.
  • Acts as the key liaison between Company and clients regarding validation issues.
  • Serves as subject matter expert for regulatory and client audits.
  • 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 Althea’s cultural values and aligns daily actions with department goals and company culture.

 

Requirements :

  • Bachelor’s degree in a Life Sciences discipline or equivalent training and experience required.
  • Generally requires a minimum of seven (7) years of experience in validation, metrology, or process engineering.
  • Minimum of three (3) years of leadership/supervisory experience performing validation functions.
  • Working knowledge of cGMPs, FDA regulations, ICH Guidelines for Manufacture of APIs, and familiarity with the European Community Guidelines for GMP.
  • Strong knowledge of aseptic process validation, drug product manufacturing process validation, cleaning validation, and equipment qualification. 
  • Experience with RABS and isolator technology is highly desirable.
  • Strong written and verbal communication skills are required.
  • Ability to effectively lead a team and work independently, within prescribed guidelines, or as a team leader or member.
  • Demonstrated ability to follow detailed directions in a laboratory/manufacturing environment.
  • Must be familiar with Microsoft Office applications.

 

Supervisory Responsibilities :

  • Directs and provides expert knowledge in the day-to-day function of Validation.
  • Identifies, recruits, and retains top-notch talent.
  • Champions Althea’s culture and empowers employees to take responsibility for their jobs and goals.
  • Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
  • Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
  • Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
  • Provides oversight and direction to the employees in accordance with Althea’s policies and procedures.

 

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.

 

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.