- Lead Production and MSAT as tightly integrated functions, owning day-to-day manufacturing execution and technical decision-making as the company transitions from pre-clinical operations into a new cGMP manufacturing facility
- Own day-to-day execution of manufacturing operations ensuring safe, compliant, and reliable batch execution
- Establish clear accountability for process ownership including yield, throughput, deviations, and continuous improvement
- Lead manufacturing readiness activities for the new facility including operational readiness, staffing, training, and go-live execution
- Work hands-on with Engineering, Facilities, Quality, and 3rd parties to support equipment qualification and manufacturing area readiness
- Develop manufacturing strategies to support early and late-stage clinical as well as commercial manufacturing for future production and capacity expansion
- Oversee MSAT responsibilities including process characterization, tech transfer, and process validation
- Hold the MSAT team to a high bar for scientific and engineering excellence, ensuring process decisions are grounded in robust data and mechanistic understanding
- Drive data-driven process improvements under manufacturing and analytical data to improve robustness and consistency
- Build, mentor, and develop a high-performing Manufacturing and MSAT team capable of operating in a fast-moving startup environment
- Establish and implement lightweight manufacturing organizational structures, workflows, and standard practices appropriate for a growing GMP operation
- Provide clear technical and operational input to leadership on manufacturing risks, timelines, and scale-up strategy
- Bachelor's degree in Biochemical Engineering, Chemical Engineering, Chemistry, or a closely related technical discipline required
- Advanced degree (M.S. or Ph.D.) in a related field preferred
- 8 years+ of experience in GMP manufacturing, MSAT, process engineering, or technical operations within biotech, biopharma, or related regulated manufacturing environments
- Demonstrated experience leading or directly supporting GMP manufacturing operations including hands-on involvement
- Prior experience supporting or leading startup activities in new facilities or new manufacturing suites
- Experience managing and developing small, highly technical teams, preferably in a startup environment
- Experience in early-stage or clinical manufacturing environments (pre-IND through Phase II) strongly preferred
- Strong engineering or related technical foundation, with the ability to reason from first principles about process behavior, risk, and variability
- Hands-on GMP manufacturing expertise, including deviation investigation, root-cause analysis, and process troubleshooting on the production floor
- Data driven decision making, using experimental design and trend analysis of manufacturing data to improve robustness and consistency
- Ability to translate experimental processes into manufacturable GMP operations, balancing rigor, speed, and fit-for-stage execution
- Clear technical and organizational communicator and cross functional collaborator. Able to align operations, engineers, scientists, and leadership around sound technical decisions
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We are looking for a motivated and hands-on Head of Manufacturing to join our team. · The Head of Manufacturing will lead our manufacturing and MSAT teams as we transition from pre-clinical manufacturing and move into our newly built cGMP production facility.Manufacturing and MSA ...
Thousand Oaks $130,000 - $180,000 (USD)1 week ago
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Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Check us out ...
Thousand Oaks $120,000 - $200,000 (USD) per year7 hours ago
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· We are partnering with our client, 20BLOC Inc., to hire a Quality Operations Specialist · About 20BLOC: · Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-bas ...
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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I sub ...
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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I sub ...
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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I sub ...
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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I sub ...
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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I sub ...
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This position will assist Compliance Investigators with manufacturing investigations and serve as a support administrator to assist manufacturing investigations and/or audits. · Assist Compliance Investigators with manufacturing investigations · Serve as a support administrator t ...
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Only for registered members
Join Amgens Mission of Serving Patients At Amgen if you feel like youre part of something bigger its because you are Our shared missionto serve patients living with serious illnessesdrives all that we do Since 1980 weve helped pioneer the world of biotech in our fight against the ...
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Head of Manufacturing - Newbury Park - The O'Connor Group
Description
We are partnering with our client, 20BLOC Inc., to hire a Quality Operations Specialist
About 20BLOC:
Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Check us out at .
We are looking for a motivated and hands-on Head of Manufacturing to join our team.
Position Overview:
The Head of Manufacturing will lead our manufacturing and MSAT teams as we transition from pre-clinical manufacturing and move into our newly built cGMP production facility. This role is responsible for the management and day-to-day oversight of our manufacturing and MSAT functions and will provide strategic direction to the business as we continue to scale and plan for future production needs. The Head of Manufacturing works closely with quality, supply chain, R&D, and other cross-functional teams to ensure product quality, data integrity, and regulatory compliance.
Key Responsibilities:
Manufacturing and MSAT Leadership
Compensation: The salary range for this position is $130, to $180,000.00 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.
20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics.
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head of manufacturing
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head of manufacturing
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Executive Medical Director, Global Safety
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Only for registered members Thousand Oaks
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Head of Critical Utilities
Only for registered members Thousand Oaks