Back to jobs
New

Senior Staff Manufacturing Process Engineer

Foster City, CA

We’re a well-funded start-up. You’ll get a chance to wear many hats, be a part of a growing team, and have the potential for exciting financial and career growth.

Here’s what sets us apart. We’ve set our sights on some of the biggest challenges facing biology today. We’re amassing a world class team of engineers, scientists, team builders and problem solvers to tackle these challenges heads-on. We’re passionate about developing the next generation technologies that will unravel the complexities of biology.

This is a unique opportunity to build, be part of an exciting start-up and be surrounded by good humans who are super capable, humble and down-to- earth.

We are looking for a Senior Staff Manufacturing Process Engineer to join the team. This role will play a critical part in scaling and maturing manufacturing for the key consumable components of our novel life science instrument platform. The Sr. Staff Manufacturing Process Engineer will oversee the consumable life cycle management (LCM) - from New Product Introduction (NPI) to drive continuous improvement across Manufacturing and lead sustaining engineering for released consumable products — while representing Operations on cross-functional teams throughout the product lifecycle. 
 

Essential Duties include but are not limited to the following:

  • Lead new process transfer and qualification of new consumable manufacturing processes, transitioning products from R&D & pilot scale into full-scale production.
  • Represent Consumable LCM on cross-functional teams throughout the product development lifecycle, providing manufacturability, process, and operational input into design and business decisions.
  • Own sustaining engineering support for released consumable products, including troubleshooting, root cause analysis (5-Why, fishbone, 8D) and implementation of corrective and preventive actions (CAPA). Investigate and resolve non-conformances and deviations.
  • Identify, prioritize, and lead continuous improvement projects to improve yield, cycle time, capacity, and COGs across consumable manufacturing lines.
  • Partner with Product Development Team to develop a variety of tech transfer deliverables, including product BOM, manufacturing process design, pFMEA, control plan, equipment sourcing & onboarding and process work instructions.
  • Partner with the broader Operation Team to complete operational readiness for new consumable products, including batch records, space control, labeling & packaging, supply chain readiness, MFG capacity & capability and staff training. 
  • Develop and optimize process performance monitoring system and apply Lean Manufacturing, Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE) methodologies to optimize processes and reduce variations.
  • Ability to lift to 30 lbs occasionally and to comply with personal protective equipment (PPE) requirements. 
  • Comfortable working hands-on in a manufacturing cleanroom environment as needed to support troubleshooting, validation, and process development activities.  
  • Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
  • Ability to comply with personal protective equipment requirements.

Minimum Qualifications:

  • Bachelor's degree in Mechanical, Chemical, Biochemical, Materials Science, or related Engineering discipline; advanced degree preferred. 
  • Typically requires 12 years of progressive experience in manufacturing/process engineering, spanning NPI, continuous improvement and sustaining engineering within a consumables, medical device, or life sciences manufacturing environment.  
  • Demonstrated experience leading new product introductions from development through full-scale production launch.  
  • Strong hands-on experience in cleanroom and/or ISO/cGMP manufacturing environments.  
  • Proficient in process validation methodologies (IQ/OQ/PQ), FMEA, root cause analysis, and CAPA processes.  
  • Working knowledge of statistical tools (SPC, DOE, Minitab/JMP or similar) for process characterization and improvement. 
  • Proficient in utilizing AI tools to conduct experimental design, data analysis, build MFG KPI & SPC charting and monitoring systems. 
  • Excellent cross-functional communication and project management skills, with a proven ability to represent Operations on cross-functional teams and influence technical and business decisions. 
  • Ability to author, review, and maintain technical documentation (SOPs, protocols, work instructions, batch records). 
  • Demonstrated ability to perform the Essential Duties of the position with or without reasonable accommodations. 

Preferred Qualifications:

  • Experience with flow cell, microfluidics, reagents, or other single-cell/genomics consumable manufacturing.
  • Lean/Six Sigma Green Belt or Black Belt certification.
  • Project Management (PMP) certification.  
  • Experience with manufacturing automation implementation and scale up.
  • Experience with MFG ERP, MES, PLM, and web-based batch record systems.
  • Prior experience in a fast-paced start-up environment, comfortable wearing multiple hats.  

We  provide competitive total compensation packages, including base pay, benefits, and equity. In California, the estimated base salary range for this position is $160,000- $210,000/year. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

What you can expect from us:

You’ll feel the energy when you walk in our door – we work hard, we have fun and we have ambitious plans to grow. Cellanome offers a comprehensive employment package that includes a competitive salary, generous stock options, great individual, and family health plans, a 401(k) and flexibility to balance work and life.

We embrace and celebrate the diversity of our employees. We are committed to equal employment opportunity regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, veteran status, or other class protected by applicable law. We are proud to be an equal opportunity workplace.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Create a Job Alert

Interested in building your career at Cellanome? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Cellanome’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 07/31/2029

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.