Supervisor of Drug Substance Manufacturing - Downstream - San Diego, CA | Biospace
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Supervisor of Drug Substance Manufacturing - Downstream

Ajinomoto Althea, Inc.

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Location:
San Diego, CA
Posted Date:
5/10/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Manufacturing, Manufacturing/Production,

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 Supervisor of Drug Substance Manufacturing - Downstream. In this visible role, you will not only lead the day-to-day responsibilities of the Drug Substance Manufacturing Downstream staff, but will be responsible for execution of purification of several multi-million dollar critical drug substance campaigns.  Variety and challenge are intrinsic to this role, where you will not only partner with senior management, but across multiple functions, i.e. Quality Control, Quality Assurance, Support Services, Engineering, Facilities, and Project Management. Your strong technical and proven leadership abilities will ensure your success. You will participate in planning, decision-making, developing implementation strategies and leading efforts for production projects. Compliance with established Good Manufacturing Practices (GMP), safety, and regulatory regulations is required.  



Responsibilities:
•Supervises Drug Substance Manufacturing Downstream group projects.  Proactively accepts personal responsibility that all projects are executed properly, attaining desired outcomes on schedule and meeting quality standards.
•Leads and mentors Downstream staff; serves as role-model and provides career direction to develop junior team members.
•Leads the execution of manufacturing campaigns under the guidelines of established SOPs and cGMP regulations.
•Completes all job related, ’read and understood’ and qualified GMP training tasks within Master Control (Quality System Software).
•Builds sound relationships within the Downstream group, clients, and internal Althea departments to assure successful technical transfer and integration of processes into Althea’s Drug Substance Manufacturing department to complete manufacturing programs on schedule with well-planned support from all required departments.
•Uses knowledge and skills to perform a range of Downstream manufacturing processes, including chromatography, UF/DF and various forms of filtration. Trains junior group members on execution of manufacturing processes and equipment utilization.
•Functions as subject matter expert with clients for manufacturing programs.
•Schedules and participates in downstream manufacturing operations for client projects and internal Althea needs.
•Troubleshoots manufacturing processes. Leads the team to identify issues and proposes adequate solutions.
•Assists in the research and implementation of new methods and technologies to enhance operations. Participates in the establishment and continuous improvement of downstream policies and procedures.    
•Authors, reviews and approves SOPs, batch records and other cGMP documentation (i.e. deviations and preventative actions).
•May cross-train on various tasks including upstream cGMP manufacturing and R&D processes as needed, to support overall success of the Drug Substance Manufacturing group.
•Maintains cGMP environment in manufacturing suites and remains current in GMP training.
•Serves as downstream representative during regulatory inspections, internal, and external 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 by aligning daily actions with department goals and company culture.
•Supports, encourages and collaborates with others, especially in difficult and high pressure situations.

Supervisory Responsibilities:
•Manage non-exempt Drug Substance 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.

Requirements

Requirements:
•High School Diploma or equivalent required. Bachelor’s degree in a life sciences discipline or equivalent strongly preferred.
•Minimum of five (5) years of experience in downstream biologics manufacturing.
•Minimum of one to three (1-3) years of functional 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.

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.