Manager, Drug Substance Manufacturing - Upstream - San Diego, CA | Biospace
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Manager, Drug Substance Manufacturing - Upstream

Ajinomoto Althea, Inc.

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Location:
San Diego, CA
Posted Date:
5/16/2017
Position Type:
Full time
Job Code:
Salary:
DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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, Drug Substance Manufacturing - Upstream to manage the Upstream Manufacturing group responsible for cGMP production of protein and plasmid DNA products. This position leads efforts for production projects by working directly with clients’ technical and project management groups as well as Althea’s Process Science group to assure successful technical transfer and integration of processes into Althea’s manufacturing department. The Manager, Drug Substance Manufacturing - Upstream, coordinates with other departments to plan, schedule, and execute all production operations in a cGMP environment. This position participates in planning, decision-making and strategizing for the Upstream group. The manager also leads the Upstream team to deliver quality product on a timely manner.



Responsibilities:
•Manages and trains Upstream Manufacturing personnel involved in cGMP fermentation, harvest and chromatography load preparation. Ensures that all projects are executed properly, attaining desired outcomes on schedule and meeting quality standards.
•Leads and mentors Upstream staff; serves as role-model and provides career development and direction.
•Directs and participates in manufacturing activities including scheduling, document production and review, and assures of cGMP compliance. Uses knowledge and skills to train others on execution of manufacturing processes and utilization of equipment.
•Interacts with clients and interdepartmentally to assure successful technical transfer and integration of processes into Althea’s manufacturing department and to complete manufacturing programs on schedule with well-planned support from all required departments.
•Functions as subject matter expert for manufacturing programs.
•Analyzes results, writes and reviews reports, and presents conclusions to internal and external customers.
•Works with Process Engineering to design related instrumentation and equipment.
•Employs high level technical expertise to develop new techniques and creatively solve problems, including troubleshooting existing manufacturing processes. Assists other technical personnel to solve issues and problems.
•Researches and implements new methods and technologies to enhance operations. Suggests improvements to existing methods and procedures.
•Reviews and approves SOPs, master batch records, and other cGMP documentation.
•May cross-train on various tasks including Downstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.
•Leads and/or manages continuous improvement projects pertaining to equipment, processes, systems or training.
•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

Supervisory Responsibilities:
•Manage exempt and non-exempt Biologics Manufacturing staff.
•Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating and managing performance and rewarding as appropriate.
•Identifies, recruits and retains top-notch talent.



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.