Sr/Principal Process Engineer

BioSpace; Redwood City (CA); Presencial; USD 150.000 - 230.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

Life Insurance

Disability Insurance

401k with Match

Company Equity

PTO and Holidays

ESPP

Flexible Spending Accounts

Student Debt Program

Mental Health Program

Onsite Gym

Descripción de la vacante

BioSpace is seeking a senior leader to drive hands-on process development for the ECO Synthesis platform in collaboration with R&D, Operations, Quality, and Engineering teams.

You will steer scale-up activities to ensure robust, well-characterized processes ready for cGMP manufacturing, while championing safety, GDP-compliant documentation, and rigorous data analysis.

Formación

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related field with 10+ years of industrial experience, or MS with 8+ years.

Responsabilidades

• Provide technical leadership in process development for ECO Synthesis platform.
• Lead scale-up strategy ensuring robustness and GMP readiness.
• Maintain laboratory safety, GDP-compliant documentation, and risk assessments.
• Mentor early-career engineers and scientists on documentation and experimental rigor.
• Deliver technical work and technology transfer packages for siRNA processes.
• Create engineering design tools: mass/energy balances, PFDs, equipment specs, cost models.
• Serve as liaison with external vendors for equipment qualification and support.

Conocimientos

Flow chemistry

Biocatalysis

Oligonucleotide synthesis

Process modeling

Statistical analysis

Leadership

Cross-functional collaboration

Python

R

Educación

Bachelor’s degree in Chemical Engineering or Biochemical Engineering

MS with 8+ years experience

Herramientas

Aspen Plus

SuperPro Designer

COMSOL

DynoChem

Python

R

JMP

Descripción del empleo

Key Responsibilities

Providing technical leadership in hands‑on process development, applying advanced engineering principles to drive the design, build‑out, and maturation of the ECO Synthesis® platform in close partnership with cross‑functional development teams

Leading the scale‑up strategy for the ECO Synthesis® platform, ensuring process is robust, well‑characterized, and ready for transition into a cGMP manufacturing environment.

Championing laboratory safety, maintaining a clean and compliant workspace, conducting process hazard analyses and risk assessments, and ensuring safe working environment for all team members.

Overseeing documentation quality, ensuring batch records, SOPs, and development reports meet GDP standards; providing mentorship and guidance to early‑career engineers and scientists on documentation and experimental/statistical rigor.

Leading the development and delivery of key technical work, including internal and external presentations, detailed technical reports, and comprehensive technology transfer packages for siRNA manufacturing processes.

Owning the creation of engineering design tools, including mass and energy balances, process flow diagrams (PFDs), equipment specifications, and cost models to support scale‑up, facility integration, and long‑term platform deployment.

Serving as primary technical liaison with external vendors, driving equipment selection, qualification, and support activities essential for effective process development and scale‑up.

Skills, Knowledge & Expertise

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related field with 10+ years of relevant industrial experience, or M.S. with 8+ years.
• Expertise in flow chemistry, biocatalysis, or oligonucleotide synthesis technologies (e.g., SPOS, enzymatic platforms).
• Demonstrated leadership in scale‑up activities, including tech transfer of biocatalytic or nucleic acid–based processes from laboratory to pilot or commercial manufacturing environments.
• Proficiency in process modeling and simulation tools such as Aspen Plus, SuperPro Designer, COMSOL, or DynoChem; and proficient with data analytics or scripting tools (e.g., R, JMP, Python).
• Strong leadership, communication skills, with the ability to collaborate effectively across cross‑functional teams including R&D, Operations, Quality, and Engineering.

Additional experience that would be valuable for this role includes

• Prior experience managing early career engineers, scientist, or research associates.
• Expertise in purification technologies, such as chromatography, filtration, or enzyme/oligonucleotide purification workflows.
• Experience with facility design or equipment specification, for nucleic acid manufacturing.
• Deep understanding of quality systems and regulatory expectations, including ISO-based quality frameworks and GMP principles.

Job Benefits

• Medical, Dental and Vision Insurance
• Basic Life, AD&D, Short- and Long-Term Disability Insurance
• 401k with Company Match up to 4%
• Company Equity
• Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time
• Annual Lifestyle Account for reimbursement of fitness programs, equipment and more
• Employee Stock Purchase Program (ESPP)
• Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)
• Student Debt Program (Company Contribution to Loans)
• Mental Health Wellness Program
• Subsidized onsite lunch program
• Onsite Gym Facilities
• Paid Parental Leave
• And More!