Senior Manufacturing Development Associate
San Francisco, CA, USA
Posted on Tuesday, January 30, 2024
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!
We are seeking a Senior Manufacturing Development Associate to join our growing team and support Pendulum’s current and future commercialization efforts. In this role, you will identify gaps and needs and resolve them with minimum supervision. You will lead other associates by example in the operation of large-scale fermenters to meet production needs for clinical trial studies, as well as for commercial release. Working closely with our stellar Manufacturing, Quality, and Compute teams, you will be working hands on in the front lines of production, while helping to continuously improve our cutting edge bioprocess from the ground up. Our ideal candidate brings previous leadership experience in a cGMP bioprocess or biotechnology setting, and enjoys working with precision in a fast-paced, changing environment, while bringing kindness, collaboration, passion, and dedication to their work.
What You'll Do:
- Assist the Plant Manager, Manufacturing Manager and Production Lead to ensure timely execution of tasks and schedule conflicts are resolved to ensure production goals are met
- Determine priorities and ensure team members are following workflows; exercise good decision making and demonstrate initiative to meet production deadlines; train/mentor junior level teammates
- Resolve technical problems; collaborate with Quality to report/investigate deviations and determine Corrective and Preventative Actions (CAPAs)
- Assist with shift scheduling coverage and be comfortable with a flexible working schedule based upon manufacturing schedule needs
- Weekly setup, running, and tear down of large scale fermentors including monitoring of in-process fermentation parameters
- Ensure batch records are filled out accurately and completely according to cGMP guidelines.
- Seed train propagation and downstream processing of fermentors
- Ensure Standard Operating Procedures (SOP) are followed and update them as required to reflect the current process
- Undertake and implement projects with a focus on safety and/or compliance risk reduction, process and equipment reliability improvement, and capacity/productivity/efficiency enhancement.
- Ensure department is clean and organized at all times and free of hazards and safety violations, maintain areas in high state of inspection preparedness
- Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and SOPs
- Ensure and assist in the following:
- -Setup, running, and tear down of large scale fermentors including monitoring of in-process fermentation parameters
- -Ensure sub-assemblies are created and sterilized according to production schedules
- -Assist in monitoring of manufacturing inventory and preventative maintenance of process equipment
- -Perform cleaning & sanitizing of facility & equipment in the food production areas as needed. Including but not limited to CIP and Sanitization of process equipment at the to established levels of cleanliness and sanitation.
- -Work to ensure production areas are organized at all times and free of hazards and safety violations, maintain areas in high state of inspection preparednessWork
- -With QA/and QC to ensure sterilized sub assemblies,Cleaned equipment and process materials are always released and available for use.
- -Maintain records to comply with regulatory requirements utilizing current Good Manufacturing
- -Practices (cGMP) and SOPsParticipate in job rotation to cover for PTO and Sick times
- AA or BA/BS in a technical field (biotechnology, chemical engineering, bioengineering, microbiology, biochemistry) or equivalent experience, and experience working in a cGMP industrial setting
- Experience with manufacturing scale fermentation units (e.g. PALL, Sartorius, DASGIP, Applikon and New Brunswick Eppendorf)
- Knowledge of anaerobic microbiological techniques and SIP & CIP of process equipment
- Ability to identify gaps and risks and be a self starter who has demonstrated the appropriate judgment and initiative to proactively address them
- Strong attention to detail and strong experience in aseptic techniques
- Ability to work flexible hours as needed on any shift
- Experience training and mentoring a junior associates and being a team player with an open, transparent communication style
- Proficient in Google suite and/or Microsoft Office
- Must be able to lift 50lbs and stand for long periods at a time
Salary & Benefits
- $77,595- $87,975
- Medical, Dental, and Vision
- Commuter Benefits
- Life & STD Insurance
- Company match on 401 (k)
- Flexible Time Off (FTO)
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.