Senior ManagerManager, Manufacturing
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Job Location:
San Diego, CA - USA
Monthly Salary:
$ 110000 - 150000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Fate Therapeutics is seeking a motivated and execution-driven Manager/Senior Manager to support GMP manufacturing operations of iPSC-derived allogenic cell therapy products. As an integral part of the Manufacturing Team this role is responsible for overseeing operational execution in addition to managing manufacturing quality events including deviations CAPAs and other required change actions. This individual will play a pivotal role in defining and executing the companys operational strategy to enable the execution of a sustainable scalable and GMP compliant manufacturing process. Accordingly this role will require proven leadership abilities to drive meaningful communication collaboration and coordination both internally within the Manufacturing department as well as cross-functionally across all levels of the organization. This is a full-time exempt position located at our corporate headquarters in San Diego CA.
Responsibilities
- Responsible for overseeing end-to-end GMP production of iPSC-based drug product from media preparation and thaw of MCBs through harvest and cryopreservation of drug product.
- Work effectively with other groups including Quality Assurance Supply Chain Quality Control MSAT Process Development and Facilities.
- Coordinate with applicable departments to manage Deviations CAPAs Continuous Improvements Impact Assessments and Change Actions.
- Assure manufacturing facility is maintained in an inspection-ready state at all times.
- Engage with Materials Management and Planning and Sourcing teams to assure adequate inventory of raw materials to support planned production activities.
- Project management utilizing tools including but not limited to SmartSheet and Microsoft Office tools.
- Assure manufacturing staff meet and maintain cGMP training requirements.
- Develop personnel schedules to allow effective execution of manufacturing activities.
- Review and approve applicable manufacturing-related documentation.
- Lead authorship and review process of SOPs and GMP BRs.
- Identify potential process improvements for Manufacturing and design appropriate experiments to evaluate and implement those changes.
- May hire oversee train and motivate team members ensuring that team goals are met efficiently.
Qualifications
- Bachelors or Masters degree in a relevant discipline with 6 years of Life Science GMP Manufacturing experience is required.
- A strong manufacturing administration background specifically related to tech transfer of aseptically produced cell products is preferred.
- A strong emphasis on quality event management and process improvement for manufacturing operations
- Ability to create read review and edit manufacturing related documents including Batch Records SOPs Work Instructions and associated forms.
- Self-motivated flexible able to prioritize multi-task and work in a fast-paced & dynamic environment.
- Experience leading projects and managing teams is required.
Working Conditions
- Subject to extended periods of sitting and standing vision to monitor and moderate noise levels.
- Will require working with cells and cell lines of human and/or animal origin.
- Will require working with hazardous materials.
- Will require work in controlled and cGMP Manufacturing environments requiring special gowning.
Compensation
- The salary offer will be based on a variety of factors including level experience qualifications internal equity and location.
- Fate offers a competitive employment package that includes an annual bonus equity and a generous benefits package.
- The anticipated salary range for this role is $110000 - $150000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment Opportunity
Fate Therapeutics Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
Privacy Notice
To learn about how Fate collects and uses job application information please visit Fates online Privacy Notice.
AboutFate Therapeutics Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf iPSC-derived cell products. The Companys pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates which are selectively designed incorporate novel synthetic controls of cell function and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego CA. For more information please visit .
Recruitment Fraud Alert
Recently we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo as well as employee names and job titles to gain a job seekers personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams.
Here are a few things to be aware of to help identify recruitment fraud:
- Our Talent Acquisition team only corresponds from our @ domain.
- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.
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Please exercise caution. If something feels off about your interactions we encourage you to contact us atto confirm the authenticity of the message. Your security is important to us and we appreciate your vigilance.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
Senior Manager
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
