Supervisor, Drug Product Manufacturing – Formulations
Ajinomoto Althea is currently seeking a Supervisor, Drug Product Manufacturing – Formulations. This position is responsible for implementation of all routine production and manufacturing procedures to optimize processes and regulatory requirements.
- Oversees and schedules Formulations operations and personnel within cGMP guidelines.
- Manages and facilitates project meetings, interactions and communications.
- Identifies and brings to resolution issues impacting Formulations projects.
- Troubleshoots complex manufacturing process problems. Leads the CF team to identify issues and propose adequate solutions.
- Ensures that all projects are executed properly, attaining desired outcomes on schedule and meeting quality standards.
- Interacts and communicates with clients regarding production.
- Maintains aseptic regulatory standards for aseptic manufacturing process.
- Develops scalable processes with improved product yield and reduces costs for manufacturing systems.
- Coordinates with multiple departments including sales and quality on production deliverables.
- Ensures that employees performing operations have obtained proper training on methods, cGMP guidelines, and SOP’s.
- Writes CCNs, OOSs and deviations where applicable.
- Operates TFF system, Rotavap, chiller, Microfluidizer, Homogenizer, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven and CIP system.
- Responsible for routine maintenance of production equipment.
- Responsible for writing/reviewing Formulations batch records, reviewing SOP’s pertaining to Complex Formulations processes and equipment, writing/reviewing User Requirement Specifications (URSs) in preparation for the ordering and receiving of equipment to be used in the Formulations process.
- Analyzes data and results and provides conclusions and proposals.
- Assists technical manufacturing personnel groups on issues and problems that arise during development and production phases.
- Works with Manufacturing, Regulatory and Quality, Engineering and Technology groups on issues and identifies process improvement opportunities.
- 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.
Education and Experience
- Bachelor’s degree in life sciences discipline or equivalent.
- Minimum of five (5) years of experience in Formulations.
- Minimum of one to three (1-3) years of leadership/supervisory experience.
- Detail oriented with strong written and verbal communication skills.
- 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
Ajinomoto Althea, located in San Diego, CA, is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials & syringes, and protein delivery technology for recombinant protein and parenteral products. In a single location, Althea has the experience, expertise, capacity, and flexibility to serve as a strategic partner for drug development and manufacturing needs for early stage and commercial requirements.
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.
Successful candidate must pass background check and drug screen as a condition of employment.
Althea is an EOE dedicated to a diverse work force and Drug Free Work Environment.
Qualified M/F/D/V/ candidates are encouraged to apply.