Sr. Manager of Manufacturing Technical Support

Overview

The Senior Manager of Manufacturing Technical Support is responsible for leading a team of process engineers who support the design, development, standardization and maintenance of biotechnology processes utilized in the manufacturing of proteins and drug substances.

This person will be a subject matter expert on core manufacturing and operational technologies for the manufacturing group.

Operational biotechnologies include : Fermentation, Cell Culture Single Use Technology, Filtration, Centrifugation and Chromatography.

Core manufacturing technologies include Weigh and Dispense, Mixing and Buffer Preparation, Parts washing and Sterilization and Homogenization.

External US

MAJOR ACTIVITIES AND RESPONSIBILITIES :

• Proactively and regularly develops / manages individuals and team performance and capabilities.
• Ensures team activities, equipment, facilities, and personnel are operated and maintained in a state of compliance (safety and regulatory) with appropriate requirements.
• Develops, measures, and improves strategies within the team that are in alignment with manufacturing, site and global strategies.
• Provides direct reports support and guidance for ensuing process control and material inputs are capable of meeting program requirements and acceptable process output
• Drives profit plan targets to assure alignment with profit plan targets.
• Develops and maintains equipment and unit operation standards and procedures through cross functional partnerships
• Provides oversight for the development and delivery of effective skill building and training plans for a given operational technology to manufacturing technicians
• Participates in global cross functional teams to ensure harmonization of standards and practices related to manufacturing development and routine operations
• Represents the manufacturing unit for equipment purchase, new technology evaluation and implementation and changes to equipment by
• Partners with Process Development and Process Sciences to transfer processes into the manufacturing plant
• Writes, reviews and approves GMP documentation, including SOPs, Qualification Protocols, User Requirement Specifications
• Prepares complex proposals, risk assessments and presentations for Senior Management, which include the business impact and proposed mitigations
• Takes responsibility and ownership for their and their teams’ actions and openly admits to mistakes and takes appropriate actions to correct situations / change behaviors

BACKGROUND REQUIREMENTS :

• BS / BA in science, engineering or other related field
• 3-4 years of team management experience
• 7 years of experience in the biotech industry
• In-depth knowledge of cGMP requirements
• Experience with laboratory and / or manufacturing instruments / equipment
• Experience with Biotech / Pharmaceutical processes
• Ability to work in a cross functional team environment Possess a strong understanding of technology operation capabilities, limits and control strategies, with the ability to apply them to develop and / or approve equipment qualification limits.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.

S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 130 and Export Administration Regulations in 15 C.

F.R. Part 730 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.

S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.

S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

If an accommodation to the application process is needed,