Manufacturing Manager (Protein Purification) - Port Hueneme, CA | Biospace
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Manufacturing Manager (Protein Purification)

Stellar Biotechnologies, Inc.

Location:
Port Hueneme, CA
Posted Date:
5/30/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biochemistry, Biotechnology, CMC, Manufacturing, Manufacturing/Production, Process Development, Process Engineer, Protein Purification, Protein Scientist, Regulatory Affairs,

Job Description

PRIMARY JOB FUNCTION
The Manufacturing Manager is responsible for the complete oversight and management of all manufacturing and process development operations.  In addition to management responsibilities, this position requires direct participation in manufacturing and process development activities

JOB RESPONSIBILITIES
•   Manage all manufacturing and process development operations for the company’s active pharmaceutical ingredient and finished drug products.
•   Develop strategies and procedures to increase process efficiency.
•   Manage activities performed at CMOs; including technology transfer, contractual arrangements, as well as technical and strategic input before, during, and after production campaigns.
•   Create, revise and develop master batch records, standard operating procedures, and specifications in accordance with applicable regulatory standards and guidance documents.
•   Active participation in the performance of manufacturing processes and operations including: chromatography, filtration, extraction, and laboratory analysis of samples and products.
•   Develop method validation protocols and studies, according to applicable regulatory agency standards.
•   Identify vendors, raw materials and components to complete projects, negotiate deliverables with vendors, and ensure that raw materials/suppliers have been qualified per SOP.
•   Collaborate in the creation and submission of intellectual property documents (i.e. Patents) related to the manufacturing process and/or the finished products.
•   Ensure that all manufacturing and process development operations are completed in full compliance with the company’s quality system and cGMP standards.
•   Develop production and R&D schedules and budgets ensuring that corporate objectives and schedules are met.
•   Manage the transfer of process optimizations from R&D to a fully GMP compliant manufacturing process.

Requirements

QUALIFICATIONS
•   Extensive experience with the development and scale-up of protein purification pharmaceutical manufacturing via chromatography and filtration processes including: process development, process optimization, and process validation.
•   Thorough knowledge of US FDA and EMA regulatory guidelines for active pharmaceutical ingredients and finished drug products.
•   Intimate knowledge of cGMP regulations and guidance documents and their integration into pharmaceutical manufacturing.
•   Ability to generate, evaluate, and share data across functional areas for evidence based decision making.
•   Strong communication skills, and the ability to solve problems with both internal teams, as well as external customers.
•   Ability to pass a Department of Homeland Security background screening to gain access to the company’s facility.
•   Ability to handle multiple tasks and operate in a fast-paced environment.

EDUCATION
•   B.S. degree in a related field (Chemistry, Biology, Engineering, etc.) with a minimum of 8 years of direct pharmaceutical manufacturing experience.
•   Equivalent combination of education and experience will be considered.