Sr. Supervisor, Drug Product Inspection

Location
92121, San Diego
Posted
Jul 06, 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 Sr. Supervisor, Drug Product Inspection to be responsible for the implementation of all production and manufacturing procedures, to optimize processes and regulatory requirements. This position coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment.

 

Responsibilities:

  • Oversees and schedules production operations and personnel within cGMP guidelines.
  • Interacts and communicates with clients regarding production. Troubleshoots complex manufacturing process problems and issues.
  • Coordinates with multiple departments including sales and quality on production deliverables.
  • Trains employees in production methods, cGMP guidelines, and SOP’s.
  • Orders raw materials.
  • Writes batch records and writes/revises SOP’s pertaining to production processes.
  • Drafts, reviews, revises, and executes batch records, validation protocols, and reports.
  • Analyzes data and results and provides conclusions and proposals.
  • Researches and implements new methods and technologies to enhance operations.
  • Develops scalable processes with improved product yield and reduced costs for manufacturing systems.
  • Responsible for maintenance of production equipment.
  • Operates production equipment and may inspect, label, or box.
  • Collects and disposes of lab wastes according to established procedures.
  • 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:

  • Bachelor’s degree in a Life Sciences discipline or equivalent training and experience required.
  • Minimum of five (5) years of relevant experience in a manufacturing, laboratory or other applicable regulated environment.
  • Minimum of one to three (1-3) years of leadership/supervisory experience.
  • Experience with cGMP, manufacturing, machine operations, and data entry.
  • Detail oriented with strong verbal and written communication skills.
  • Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • Familiarity with Microsoft Office applications.

Supervisory Responsibilities:

  • Champions Althea’s culture and empower employees to take responsibility for their jobs and goals.
  • Engages employees by creating a climate in which they want to do their best.
  • Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance development planning.
  • Maintains employee work schedules.
  • Identifies recruits and retains top-notch talent.
  • Coaches, mentors and develops staff, including overseeing new employee onboarding and providing career development planning and training opportunities.
  • Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
  • Manages for results by setting and communicating goals and metrics.

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.