Sr. Manager of Manufacturing Technical Support
FUJIFILM Diosynth Biotechnologies
Triangle, NC
See who FUJIFILM Diosynth Biotechnologies has hired for this role
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:
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, please e-mail FDBUHR@fujifilm.com
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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
- 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 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, please e-mail FDBUHR@fujifilm.com
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Management and Manufacturing -
Industries
Biotechnology Research
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