Senda Biosciences is pioneering the field of Intersystems Biology to create novel treatments for human disease. Intersystems Biology focuses on how molecular connections between botanical, bacterial, and human cells—coevolved over millennia—define health and disease. Senda's Intersytems Biology discovery platform, built using new techniques in machine learning and computational biology, has been able to generate novel, actionable insights into the trillions of interspecies molecular connections in the human body, and harnesses the power of this "pharmacy within us" with novel pharmacological approaches. The power of the Senda platform is illustrated by six preclinical programs in oncology, neurology, chronic disease, and metabolic disease. Senda was founded by Flagship Labs, the innovation foundry of Flagship Pioneering. To learn more, please visit the company's website at www.sendabiosciences.com.
The Director, Bio Process Development will have the responsibility of defining strategic approach and managing the execution of empirical studies to develop upstream and downstream processes for two novel platforms. The position will report into the VP, Process Development and Manufacturing Sciences.
- Direct all process development, scale up and characterization efforts; some hands on work is expected;
- Build a high performing process development team to achieve aggressive goals and timelines;
- Ensure a holistic and integrated approach to process development;
- Establish a culture of ideation, innovation, development, and deployment of differentiating technologies to develop high yielding, robust and scalable processes.
- Develop production and resource plans that meet production goals in terms of safety, quality, output and cost;
- Ensure that, as the company grows, capabilities meet or exceed all industry and customer requirements for cost, quality and responsiveness;
- Select, hire and develop personnel to ensure the efficient operation of the function.
- Collaborate closely with internal teams to develop an outsourced development and manufacturing strategy.
- Play an active role in negotiations and oversight of development and manufacturing partners and critical raw material suppliers
- Develop and manage budget and budget execution;
- Serve as primary author for relevant CMC sections of regulatory submissions
- Cross-functionally identify, correct, investigate and resolve all quality issues in a timely and efficient manner;
- Represent Senda Biosciences at external scientific and regulatory conferences.
- PhD in Scientific and/or Engineering discipline, 10+ years experience in Process Development role with 6+ years of experience at managerial level managing process development
- A proven track record in developing, characterizing and scaling up upstream and downstream processes for pre-clinical development and clinical manufacturing.
- Extensive hands-on experience in integrated process development, application of Quality by Design (QbD) principles, and strong expertise in use of Design of Experiment (DOE) methodologies.
- Evidence of creativity in addressing process development manufacturing approaches is required.
- Expertise in development of in-process assays to monitor process performance required.
- Familiarity with a contract manufacturing environment with an in-depth knowledge of biologics drug product unit operations, impact of process parameters, in-process characterization techniques, process development, and principles of cGMP is a plus.
- Demonstrated experience as primary author of relevant sections of INDs, IMPs and other regulatory documents.
- Hands-on, can-do individual with a collaborative personal style and the ability to work well in a fast-moving team/collaborative environment.
- Ability to effectively work independently and in a team environment.
- Active participation in the scientific community through a record of peer-reviewed publications and/or patents as well as active participation in industry forums and/or conferences.
- Established success developing staff, including effective feedback and coaching or mentoring.
Senda Biosciences is an Equal Opportunity Employer. Senda does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.