Manufacturing Engineering Manager

Location
Brisbane, CA, United States
Posted
May 26, 2021
Ref
1382495714
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY

Mammoth Biosciences is harnessing the diversity of nature to power the next-generation of CRISPR products. Through the discovery and development of novel CRISPR systems, the company is enabling the full potential of its platform to read and write the code of life. By leveraging its internal research and development and exclusive licensing to patents related to Cas12, Cas13, Cas14 and CasPhi, Mammoth Biosciences is advancing disease detection and treatment using its novel CRISPR systems that can deliver on the promise of precision medicine across diagnostics and therapeutics. Furthermore, Mammoth's CRISPR technology platform will enable new solutions in life science research, healthcare, agriculture, biodefense and more.

Based in the San Francisco Bay Area, Mammoth Biosciences is co-founded by CRISPR pioneer and Nobel Prize winner Jennifer Doudna and principal founders Trevor Martin, Janice Chen, and Lucas Harrington. The firm is backed by top institutional investors including Decheng, Mayfield, NFX, and 8VC, and leading individual investors including Brook Byers, Tim Cook, Bob Nelsen, and Jeff Huber.

TEAM

The Diagnostics team is advancing our CRISPR-based DETECTRâ„¢ platform to address unmet needs across the continuum of testing. From laboratories to the home, our mission is to democratize diagnostics with CRISPR.

OPPORTUNITY

Mammoth is looking for an experienced Manufacturing Engineering professional that will build and lead a team of 5 to 9 persons. This position is critical to Mammoth's charter of using innovative CRISPR enzymes in diagnostic products. The Manufacturing Engineering team will be the technical center for prototyping, developing manufacturing work instructions, developing manufacturing processes and test methods, selecting and interfacing with external contract manufacturing organizations, and reliability testing.

The manufacture of Mammoth's diagnostic products involve chemical reagents, thermoformed and injection molded plastics and high throughput plastic assembly operations to produce devices capable of performing molecular diagnostic testing utilizing CRISPR Cas enzymes.

This team will lead and be the center of efforts in developing and transferring manufacturing processes for the formulation and filling of reagents, the assembly of plastic components, and the packaging. This team in coordination with CMOs, lead the development of in-coming, in-process and final quality control test methods.

This team will also have a leadership responsibility in generating component and module reliability testing data.

KEY RESPONSIBILITIES
    • Work with a team of scientists and engineers from diverse fields to support Mammoth's diagnostics product portfolio from concept and design through, verification and validation, design transfer and commercialization
    • Manage a team of 6 persons that will grow to 9 persons or more in subsequent years
    • Assemble and test prototype devices that execute CRISPR-based molecular diagnostic assays; with the engineering design team, develop workflows and assembly work instructions, and quality control test methods; execute the draft assembly instructions and update the work instructions until ready for Design Transfer; execute mechanical, electrical and functional testing of prototypes; record original data and provide data results to the engineering team; evaluate the assembly and testing results with the engineering team
    • Be the primary interface with Mammoth's chosen contract manufacturing organizations (CMOs)
    • Maintain the assembly equipment within Mammoth's Quality Management System (QMS) by ensuring all calibrated devices are within specification and providing documents to the QMS files


REQUIRED QUALIFICATIONS
    • A minimum of 7 years industry experience working in a manufacturing development team that is developing a medical device or in-vitro diagnostic product
    • Bachelor of Science degree in an engineering field of study
    • Experience in working on products that have been commercialized or will be commercialized within 3 years
    • Experience working with automated and semi-automated assembly and test instruments such as laser welders, ultrasonic welders, pressure decay test instruments


PREFERRED QUALIFICATIONS
    • Experience working in the medical device or IVD industry within a 21 CFR 820 quality management system
    • Bachelor of Science degree or Masters of Science degree in Manufacturing/Industrial Engineering or Chemical Engineering
    • A minimum of 7 years industry experience working in a manufacturing development team that is developing a medical device or in-vitro diagnostic product that uses chemical reagents


BENEFITS
    • Company-paid health/vision/dental benefits
    • Unlimited vacation and generous sick time
    • Company-sponsored meals and snacks
    • Wellness, caregiver and ergonomics benefits
    • 401(k) with company matching


It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation.