Lead Process Engineer

2 weeks ago

San Francisco, California, United States Cellares Corporation Full time

Position Overview

We are in search of a dynamic and highly skilled Senior Process Engineer to become a vital member of the MSAT team, playing a crucial role in the advancement of our cutting-edge cell therapy manufacturing platform.

This role entails overseeing the initiatives related to the development, process transfer, compliance, and scalability of Cellares' manufacturing operations. The selected candidate will concentrate on the transfer of technology from Process Development to cGMP manufacturing, while also spearheading the development of process automation aimed at enhancing reliability, safety, cost-effectiveness, scalability, and compliance. Additionally, this individual will provide support on the shop floor and act as a subject matter expert (SME) for all facets of the manufacturing process.

This position is multidisciplinary, necessitating the ability to collaborate with both internal and external stakeholders across various functional areas to devise optimal solutions. The ideal candidate will possess extensive expertise in technology transfer and Manufacturing Science and Technology, and will be expected to work closely with other functional areas and partners to ensure that deliverables are achieved.

Candidates should thrive in a fast-paced, mission-driven environment and be ready to address a wide array of challenges as the organization expands.

Key Responsibilities
  • Convert client requirements into actionable project plans
  • Oversee technology transfer activities at the site level, including scale-up and process adaptations
  • Lead and/or assist in late-stage process development activities, including characterization, comparability, and qualification/validation
  • Manage the technology transfer from Process Development to cGMP Manufacturing operations, including authoring change records, drafting/reviewing/approving SOPs and batch records, and training manufacturing staff
  • Facilitate the development of manufacturing operations and business processes, including GMP system implementation and GMP readiness tasks
  • Assist in labor and equipment capacity modeling and engage in the sales and operations planning process (S&OP) for supply review
  • Define and provide user requirements for process equipment across multiple facilities for cell therapy manufacturing
  • Support the implementation and user acceptance testing (UAT) of Cellares software solutions
  • Lead root cause investigations and train manufacturing personnel to ensure robust root cause analysis
  • Recommend and implement corrective and preventive actions (CAPAs) as needed, ensuring effectiveness checks to prevent recurrence
  • Generate process or operational-related Failure Modes and Effects Analysis (FMEA) and associated mitigations and actions
  • Create training and onboarding materials for new hires and new methodologies
  • Maintain and report on process run summaries and ongoing process verification reports
  • Prepare and present data related to manufacturing processes to internal and external partners, as well as regulatory inspectors
  • Support process qualification and validation preparation, execution, monitoring, and reporting
  • Collaborate with clients on mapping manufacturing processes
Qualifications
  • Bachelor's Degree in a scientific or related discipline is required
  • A minimum of 5+ years of experience in the biotech/biopharma sector within cGMP Operations, ideally in cell and gene therapy
  • Proven experience with technology transfer in the Pharma/Biotech field
  • Experience in drafting and reviewing GMP documentation is essential
  • Strong analytical, problem-solving, and critical thinking abilities, with a capacity to lead as a change agent promoting flexibility, creativity, and accountability
  • Excellent teamwork and interpersonal skills, with the ability to influence and build strong relationships at all organizational levels
  • Familiarity with Operational Excellence and/or Lean Manufacturing is advantageous
  • Exceptional planning, organizational, technical writing, and time-management skills, including the ability to support, problem-solve, and prioritize multiple projects and deadlines

About Cellares

Cellares is pioneering the Integrated Development and Manufacturing Organization (IDMO) model, employing an Industry 4.0 approach to mass manufacture the living drugs of the 21st century. The company is innovating and operating integrated technologies for cell therapy manufacturing to enhance access to life-saving therapies. The Cell Shuttle technology integrates all necessary components for the entire manufacturing process into a flexible, high-throughput platform that offers true walk-away, end-to-end automation. These Cell Shuttles will be deployed in Cellares' Smart Factories globally to meet the total demand for cell therapies.

Headquartered in South San Francisco, California, with a commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, Cellares is backed by top-tier investors and has successfully raised over $355 million in funding.

Compensation includes a competitive base salary, comprehensive medical, dental, and vision plans, 401(k) matching, free EV charging, onsite lunches, and stock options. All displayed pay ranges are approximate, negotiable, and dependent on location.

  • Lead Process Engineer

    2 weeks ago

    San Francisco, California, United States Ammobia Full time

    Principal Process EngineerAbout AmmobiaAmmobia is dedicated to transforming the ammonia sector. As a pioneering startup, we are innovating the Haber Bosch 2.0 process, which facilitates efficient and sustainable ammonia production. Traditionally, ammonia manufacturing has been a significant source of pollution, characterized by a rigid and slow-moving...

  • Lead Process Engineer

    1 week ago

    San Francisco, California, United States Cellares Corporation Full time

    Position OverviewCellares Corporation is on the lookout for a dynamic and highly skilled Senior Process Engineer to become a vital part of our MSAT team, playing a crucial role in the advancement of our cutting-edge cell therapy manufacturing platform.This role encompasses a range of responsibilities related to the development, transfer, compliance, and...

  • Process Engineer

    3 days ago

    San Francisco, California, United States Page Full time

    About the RoleWe are seeking a highly skilled Process Engineer to join our team at Page. As a key member of our engineering team, you will be responsible for designing and implementing process systems for our clients.Key ResponsibilitiesDesign and develop process systems, including process-mechanical, Bulk Gas delivery, and PSSS (VHP/Gas/Chemical)...

  • Process Engineering Lead

    2 weeks ago

    San Francisco, California, United States ICONMA, LLC Full time

    Role OverviewThe Software Asset Management Lead plays a crucial role in supporting the IT organization by overseeing the comprehensive software asset management processes.Key ResponsibilitiesCollaborate with the ITSM Manager to enhance software asset management practices.Work closely with the Software Asset Management Process Owner to ensure effective...

  • Process Engineering Lead

    2 weeks ago

    San Francisco, California, United States ICONMA, LLC Full time

    Position OverviewThe Software Asset Management Lead plays a crucial role in supporting the IT department by overseeing the comprehensive software asset management processes.Key ResponsibilitiesCollaborate with the ITSM Manager to enhance software asset processes.Engage with the Software Asset Management Process Owner to ensure effective implementation and...

  • Lead Process Engineer for Ammonia Innovation

    2 weeks ago

    San Francisco, California, United States Ammobia Full time

    Principal Process Engineer About Ammobia Ammobia is dedicated to transforming the ammonia sector. As a pioneering startup, we are advancing Haber Bosch 2.0 - an innovative ammonia synthesis method that facilitates efficient and environmentally friendly ammonia production. Traditionally, ammonia manufacturing has been a significant source of pollution,...

  • Lead Process Engineer for Ammonia Innovation

    2 weeks ago

    San Francisco, California, United States Ammobia Full time

    Principal Process EngineerAbout AmmobiaAmmobia is dedicated to transforming the ammonia sector. As a pioneering startup, we are advancing Haber Bosch 2.0 – an innovative ammonia synthesis method that facilitates efficient and environmentally friendly ammonia production. Traditionally, ammonia manufacturing has been a significant source of pollution,...

  • Lead Process Engineer for Ammonia Innovation

    2 weeks ago

    San Francisco, California, United States Ammobia Full time

    Principal Process Engineer About Ammobia Ammobia is committed to transforming the ammonia sector. As a pioneering startup, we are advancing Haber Bosch 2.0 - an innovative ammonia synthesis method that facilitates efficient and environmentally friendly ammonia production. Historically, ammonia generation has been a significant source of pollution,...

  • Lead Process Engineer for Ammonia Innovation

    2 weeks ago

    San Francisco, California, United States Ammobia Full time

    Principal Process Engineer About Ammobia Ammobia is dedicated to transforming the ammonia sector. As a pioneering startup, we are developing Haber Bosch 2.0, an innovative ammonia synthesis method that enables efficient and environmentally friendly ammonia production. Traditional ammonia manufacturing has been characterized by significant pollution and...

  • Lead Process Engineer for Ammonia Innovation

    2 weeks ago

    San Francisco, California, United States Ammobia Full time

    Principal Process EngineerAbout AmmobiaAmmobia is dedicated to transforming the ammonia sector. As a pioneering startup, we are advancing the Haber Bosch 2.0 process, which facilitates efficient and environmentally friendly ammonia production. Traditionally, ammonia manufacturing has been associated with significant pollution and a rigid operational...

  • Process Engineering Manager

    2 months ago

    San Francisco, California, United States Diamond Foundry Full time

    We are seeking a dedicated and experienced Process Engineering Manager to join our team in the semiconductor industry. The ideal candidate will oversee and optimize manufacturing processes to enhance yield, quality, and compliance with industry standards.Responsibilities:Collaborate and coordinate with a cross functional team to transfer technology from R&D...

  • Process Engineering Internship Opportunity

    3 days ago

    San Francisco, California, United States RippleMatch Opportunities Full time

    About RippleMatch OpportunitiesRippleMatch Opportunities is a leading platform that connects top talent with top employers. Our AI-powered job matchmaker brings opportunities directly to you by matching you with jobs you are qualified for.Role OverviewThis role is with RippleMatch's partner companies, who are looking to hire top talent. As a Process...

  • Lead Process Engineer for Innovative Ammonia Solutions

    2 weeks ago

    San Francisco, California, United States Ammobia Full time

    Principal Process EngineerAbout AmmobiaAmmobia is dedicated to transforming the ammonia sector. As a pioneering startup, we are advancing the Haber Bosch 2.0 – a state-of-the-art ammonia synthesis method that facilitates efficient and environmentally friendly ammonia production. Historically, ammonia manufacturing has been a significant source of...

  • Lead Process Engineer

    2 weeks ago

    San Jose, California, United States Sanmina-SCI Full time

    Lead Process Engineer - Plating TechnologiesThe printed circuit board (PCB) sector is undergoing a significant transformation, emphasizing cutting-edge technology and miniaturization. Sanmina-SCI's PCB division is at the forefront of this evolution, presenting remarkable opportunities for proficient engineers across diverse disciplines. We are seeking...

  • Process Improvement Engineer

    2 weeks ago

    San Francisco, California, United States Championx Full time

    ChampionX is on the lookout for a skilled Process Improvement Engineer to enhance our team. This role presents a unique chance to contribute to a company that is consistently evolving and offers a competitive salary along with a comprehensive benefits package. Why You Should Explore This Opportunity: Become part of an organization that prioritizes employee...

  • Process Engineer

    1 week ago

    San Francisco, California, United States Primient Full time

    About PrimientPrimient is a leading manufacturer of plant-based ingredients, committed to producing safe, high-quality, and sustainable products. Our company values include Safety, Excellence, Integrity, and Growth, and we strive to create a collaborative and inclusive work environment.The OpportunityWe are seeking a highly skilled Process Engineer to join...

  • Lead Scientist, Fermentation Process Engineering

    2 weeks ago

    San Diego, California, United States Web-atrio Full time

    Lead Scientist, Fermentation Process EngineeringStatus: ArchivedCompany: Web-atrioSUMMARY:The Lead Scientist will serve as a key contributor in the optimization of biologics manufacturing processes, including scale-up, technology transfer, and process validation, aimed at advancing late-stage biologics towards commercialization.The ideal candidate will...

  • Process Engineering Trainee

    2 weeks ago

    San Francisco, California, United States RippleMatch Opportunities Full time

    Position OverviewThis internship opportunity is associated with RippleMatch's partner organizations.About RippleMatchRippleMatch is revolutionizing the recruitment landscape for the Gen Z workforce. By streamlining the hiring process through innovative matching technology and automation, RippleMatch significantly reduces the time-consuming aspects of...

  • Engineering Manager, Molding Processes

    1 week ago

    San Francisco, California, United States G&W Electric Full time

    About G&W Electric: G&W Electric has been a pioneer in engineered electrical power grid solutions since 1905. Joining our team means becoming part of a global network of dedicated manufacturing professionals committed to enhancing the technologies that ensure safe and reliable electricity delivery. Our workplace culture prioritizes employee success,...

  • Lead Industrial Process Engineer

    2 weeks ago

    San Bernardino, California, United States Burlington Stores Full time

    Position SummaryAs a Lead Industrial Process Engineer at Burlington Stores, you will be instrumental in enhancing operational effectiveness and fostering productivity advancements. Your responsibilities will include establishing and sustaining precise engineered benchmarks, defining and promoting "Best Practices" across various job roles, and aligning with...