About Us:

Culture’s mission is to make bioprocess development and scale-up as fast and easy as scaling software. Towards this aim, Culture’s first offering enables biopharma, biotechnology, and synthetic biology companies to run their bioprocessing R&D in the cloud. Clients design, manage, and analyze bioprocess experiments in Culture’s Console web application. Culture’s offering enables customers to focus on designing and improving their process versus spending time and effort building out their own high-throughput process development laboratory. While customers remotely observe the process and analyze data, the experiments are executed in Culture’s cloud bioreactor facility in South San Francisco. The facility is enabled by Culture’s proprietary 250mL and 5L single-use bioreactor technology and software systems.

At Culture, we combine our passions for biomanufacturing, engineering, and operations to build new solutions that make bioprocess development and scale-up faster. We value curiosity, communication, collaboration, customer focus and a drive for results.

The Opportunity:

Culture Biosciences is looking for a Senior Manufacturing Engineer to help with transition of new products from design to manufacturing. We are looking for a candidate to develop and maintain manufacturing processes that deliver reliable and high-performance hardware. You will work with internal team members from the fields of mechanical, electrical, bio, and chemical engineering to improve and maintain high quality bioreactors and single use assemblies.

What you'll do:

• Lead design transfer to manufacturing activities. Play a key role in creating device master record for the new product.
• Participate in design and validation and verification of the manufacturing process for the new product.
• Create and maintain manufacturing process instructions, and standard operating procedures for manufacturing.
• Set up manufacturing data collection and analysis to monitor KPIs and guide process improvements.
• Adjust manufacturing processes and documentation to ISO 9001 requirements.
• Be the technical interface between the Hardware R&D, Bio-Ops team, and the Manufacturing team.
• Scale hardware engineering prototypes from conception to higher manufacturing volumes.
• Enhance Culture's in-house manufacturing capabilities as well as our external manufacturing partnerships.
• Manage, initiate, and implement documentation control and change order system.
• Identify the root cause of hardware quality issues, often by designing and performing tests.

About you:

• Bachelor's degree in an engineering discipline (Mechanical, Aerospace, Biomedical or comparable).
• 8+ years professional experience as a manufacturing engineer in ISO 9001/13485 environment.
• Have practical knowledge of ISO 9001 and ISO 13485 requirements.
• Experienced in Lean Manufacturing and Manufacturing Quality Control.
• You have experience working with ERP systems (NetSuite, SAP)
• Able to work cross-functionally with different teams or departments.
• You’re proactive and a self-starter.
• You’re either already passionate about or curious about how biomanufacturing, biotechnology, biomedical sciences, bioengineering, and/or synthetic biology can positively impact human health and the planet.
• You are kind, curious, and enjoy learning new things.
• You value communication and connection on a multidisciplinary team.
• You have experience working in a CAD platform.
• You have experience using product life cycle management system (Agile / Arena)

In return, we offer a supportive environment. We value:

• Lifting each other up and enabling others to be their best.
• Commitment to reliability.
• Empowering ownership to drive progress.
• Trying new things; big innovations start with small ideas and actions.

Location & Schedule:

• This is an onsite position. We’re looking for someone based in the San Francisco Bay Area who is able to work in person at our office in South San Francisco at least 4 days per week.

Base Salary Range:

Culture Biosciences's compensation package includes market competitive salary, equity for all full time roles, and great benefits. Our expected salary range for this role is $145,000 to $170,000. We are hiring for multiple levels and backgrounds so final offers may vary within the range provided based on experience, expertise, and other factors.

Benefits:

• Competitive salary and equity compensation
• Medical, Dental, Vision, and Life insurance
• Medical and Dependent Care FSA (prorated based on start-date)
• 401(k) plan with company match
• Responsible Time Off (non-accrual based) policy, 10 paid company holidays and a week-long winter break
• 12 weeks of parental leave at full salary
• For onsite employees:
• Commuter benefits
• Access to on-site child care facility, subject to availability
• Free onsite breakfast, lunch, snacks, coffee, and gym (varies based on COVID-19 restrictions)

Culture Biosciences provides equal employment opportunities to all employees and applicants. We seek to build a company that promotes inclusion and expands the diversity of our industry as a whole. We encourage people with identities underrepresented in biotech and technology to apply.