Biotechnology

Head of Manufacturing

Fremont, CAOnsiteFull TimeManager / Head$205,000–$240,000 /yrPosted 1 month agoVisa sponsorship available

Is this role right for you?

Upload your resume and get a skill-by-skill breakdown — see exactly where you match, where you're close, and what to highlight. Not a mystery percentage.

Get a tailored resume highlighting what this role needs.

Required skills

bioprinted tissue therapeutic
BTT programs
GMP-compliant production
aseptic manufacturing
cleanroom controls
environmental monitoring
IQ/OQ/PQ
cGMP-regulated environment
critical utility management
EHS regulatory standards

Nice to have

cell and gene therapies
device and combination products
biotechnology operations
lab operations
equipment lifecycle
calibration

Role summary

Aspect Biosystems is seeking a strategic Head of Manufacturing to lead their Technical Operations team. This role will oversee facilities, lab, safety, and manufacturing operations, with a focus on aseptic manufacturing for GMP-compliant production of bioprinted tissue therapeutics. The Head of Manufacturing will be responsible for developing and executing the manufacturing strategy, ensuring operational excellence, managing costs, and fostering a culture of safety and quality. Key responsibilities include managing aseptic processes, equipment qualification, facilities planning, budget management, and leading a high-performing team. The ideal candidate has a Master's degree and 10+ years of experience in biotech/pharma operations, including 5+ years in senior leadership overseeing GMP manufacturing and aseptic processing.

We are seeking a strategic and hands-on Head of Manufacturing to join our Technical Operations team. Reporting to the Chief Technical Operations Officer you will oversee our facilities, lab operations, safety, and manufacturing operations, including aseptic manufacturing to support GMP-compliant production. This is a mission-critical role that will ensure our physical operations scale effectively to support the development and production of our bioprinted tissue therapeutic (BTT) programs as well as subsequent pipeline programs. As we continue our transition from research to clinical and commercial readiness, you will play a key role in optimizing infrastructure, enabling operational excellence, managing costs while fostering a culture of safety, quality, and accountability across our labs and manufacturing environments, with an initial focus on enabling clinical-grade production of our bioprinted tissue therapeutics.

Responsibilities

Develop and execute Aspect’s manufacturing operations strategy in alignment with organizational goals and program timelines.

Oversee aseptic manufacturing operations, including cleanroom controls, gowning procedures, environmental monitoring, and material/personnel flow to maintain contamination control and compliance with GMP standards.

Partner cross-functionally to ensure facilities and manufacturing operations enable robust execution from discovery through clinical readiness.

Build, lead, and mentor a high-performing manufacturing operations team, fostering a culture of continuous improvement, GMP compliance, and operational excellence.

Manage lab operations including equipment lifecycle, maintenance programs, calibration, and inventory management systems.

Support the implementation of manufacturing best practices, including documentation systems, materials management, and training protocols.

Lead day-to-day site operations and long term facilities planning, ensuring our labs, offices, and production areas are optimized, safe, and compliant.

Oversee the installation, qualification (IQ/OQ/PQ), maintenance, and calibration of critical manufacturing equipment, ensuring optimal performance, data integrity, and adherence to GMP standards and asset lifecycle management.

Develop and maintain robust preventative maintenance programs for manufacturing facilities and equipment, ensuring compliance with GMP requirements and managing critical building systems.

Collaborate with senior leadership to develop operational expense long range planning as well as annual budgets assess and implement facility expansion plans in line with company growth and program needs.

Champion a proactive safety culture and manage comprehensive safety programs, including biosafety, chemical safety, incident reporting, and emergency response.

Ensure compliance with all relevant occupational, environmental, and biosafety regulations.

Manage vendor relationships for services, utilities, and facilities contractors.

Qualifications & Experience

Education & Experience: Master’s degree in Engineering, Biotechnology, Life Sciences, or a related discipline, with 10+ years of experience in biotech or pharmaceutical operations, cell and gene therapies, device and combination products preferred, including 5+ years in a senior leadership role overseeing GMP manufacturing and aseptic processing.

You have deep expertise in aseptic manufacturing operations, cleanroom controls, environmental monitoring, and equipment qualification (IQ/OQ/PQ) within a strict cGMP-regulated environment.

You have a comprehensive understanding of facility design and operations, critical utility management, and EHS regulatory standards for biomanufacturing environments.

You are a strategic leader with a hands-on approach who excels at building and mentoring high-performing operational teams.

You are driven by operational excellence and continuous improvement, maintaining high standards for safety, quality, and accountability.

You are a collaborative partner capable of aligning cross-functional teams and managing vendor relationships to execute complex project timelines.

The hiring range for this role is $205,000 - $240,000, annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Base salary is just one part of the overall compensation at Aspect, team members also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

Who We Are

Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine designed to restore or supplement biological function and deliver curative therapies for some of the most elusive diseases. Aspect is developing these bioengineered cellular medicines by applying its full-stack tissue therapeutic platform, which integrates proprietary AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials. Aspect is advancing its therapeutic pipeline across multiple endocrine and metabolic diseases, including diabetes and rare endocrine disorders. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you!

Curious about our current perks and benefits? Learn more here.

All aspects of employment - including the decision to hire, promote, discipline, or terminate - are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, citizenship status, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, political affiliation, or any other status protected under federal, state, provincial, or local law.

If you're interested in joining our team but don't see a job posting that matches your experience or background, we encourage you to submit a general application to be considered for future opportunities!

Ready to apply?

You'll be redirected to Aspect Biosystems's application page.