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MSAT Process Engineer

Pendulum Therapeutics

Pendulum Therapeutics

San Francisco, CA, USA
Posted on Wednesday, January 24, 2024
About Pendulum
Pendulum® is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics (probiotics + prebiotics) that have demonstrated clinical efficacy to treat conditions like metabolic syndrome, inflammation and neurodegeneration.
Pendulum has created proprietary pipelines to build a unique discovery platform that identifies key, novel bacterial strains and the prebiotics that feed them.
We are a highly collaborative team of scientists, engineers, physicians, marketers and salespeople interested in improving human health by using the latest research from diverse fields, such as microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition. We believe strongly in an individual’s transparency and strong communication to enable the most effective and efficient path to team success.
If you’re interested in building a new category of products that will help improve the lives of people globally and you love working in a cross-functional, collaborative, inspiring environment, please continue reading!
Position Summary:
We are seeking a Manufacturing Science and Technology (MSAT) Scientist or Process Engineer to join our Process Engineering team and support Pendulum’s current and future commercialization efforts. Reporting to the Staff Engineer, you will play a crucial role in ensuring manufacturing runs smoothly. You will work closely with the manufacturing team to troubleshoot any issues that arise in manufacturing, assist engineering in developing new processes and transfer new processes to manufacturing. Additionally, you will be responsible for authoring Technical Reports, Standard Operating Procedures (SOPs), User Requirement Specifications, and Process Validation Protocols to ensure effective documentation and compliance within the manufacturing processes.

What You'll Do:

  • Perform product technology transfer such as Microbial Fermentation and Purification processes from the Process Development team to GMP Manufacturing.
  • Perform Risk Assessment & Mitigation during product technology transfer and manufacturing.
  • Act as the primary liaison between manufacturing and process engineering, delivering updates and resolving process-related issues, ensuring seamless manufacturing outcomes.
  • Author Technical Reports, SOPs, User Requirement Specifications, and Process Validation Protocols.
  • Develop a dashboard to track key performance indicators for manufacturing and equipment performance.
  • Conduct thorough evaluations of processes and equipment, recommending advancements for improved efficiency and robustness.
  • Provide technical training to Manufacturing Operators on new processes.
  • Assist in CAPA investigations and recommend dispositions.
  • Build a collaborative network, influencing cross-functional teams effectively.
  • Engage actively in departmental and company-wide initiatives, contributing to overarching goals through teamwork and leadership.
  • Maintain and update knowledge of technologies integral to both upstream and downstream manufacturing operations
  • Understake and successfully execute additional projects and assignments to refine and improve manufacturing systems.
  • Perform other duties as assigned.

Knowledge Requirements:

  • B.S. in a technical field (biotechnology, chemical engineering, bioengineering or related field).
  • 3+ years in process engineering or manufacturing operations within a pharmaceutical or biotech manufacturing organization.
  • Mandatory experience in biologics
  • Proven experience working with current Good Manufacturing Practices (cGMP) In-depth knowledge and understanding of manufacturing processes.
  • Experience with equipment commissioning and validation requirements
  • Familiarity with executing process transfer into a manufacturing setting.

Salary & Benefits

  • $87,975 - $102,638
  • Medical, Dental, and Vision
  • Commuter Benefits
  • Life & STD Insurance
  • Company match on 401 (k)
  • Flexible Time Off (FTO)
  • Equity
Pendulum Therapeutics, Inc. is committed to creating a diverse environment and is proud to be an equal
opportunity employer. All qualified applicants will receive consideration for employment without regard to
race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics,
disability, age, or veteran status. We welcome all to apply.