Senior Director, Head of CMC
2 weeks ago
Job Description
Job Description
About Seismic Therapeutic
Seismic, a biotechnology company, is determined to help patients by integrating machine learning, structural biology, protein engineering, and translational immunology to create optimized therapies for patients with autoimmune disease.
At our core, we are focused on phenomenal science, supportive culture, a diverse team, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that.
The opportunity
Seismic is seeking an experienced CMC professional to lead and run Seismic’s CMC activities.
As Senior Director you will help to establish or refine key systems and best practices and be the overall responsible day-to-day leader from a strategic, technical, and operational standpoint.
In addition to being a key contributor to the CMC strategy, this is a role that requires a dynamic, hands-on leader, who will move proactively lead the CMC function and interface seamlessly throughout our R&D org.
This is an exciting opportunity to join as a key member of the Seismic team.
The Role
Senior Director, Head of CMC
Seismic Therapeutic is seeking a highly experienced and motivated Senior Director, Head of CMC to lead our CMC operations within our Drug Creation organization. This is a critical role, that will report to Seismic’s CTO, that will oversee all aspects of our CMC activities, from cell line development to drug product manufacturing for our biologic modalities.
Responsibilities:
Oversee day-to-day CMC operations, which are completely externalized.
Own and continuously update our CMC strategy as each new development program comes online.
Leverage support from external consultant SMEs as needed.
Manage all of the CDMOs and CROs in our supply chain covering cell line development, process and formulation development, analytics, GMP drug substance and drug product manufacturing, label, pack, distribution, and storage of our cell lines and products.
Manage CMC within budget and keep timelines on track.
Anticipate and troubleshoot roadblocks and hurdles – communicating with appropriate internal stakeholders as needed
Qualifications:
Ph.D. in Chemistry, Biochemistry, or a related field.
18+ years of experience in CMC operations, preferably in large pharma and small biotech with a specific focus on biologic modalities, such as Fc fusions and monoclonal antibodies.
A technical background in process development is desirable with broad knowledge around upstream, downstream, formulation and analytical development
Proven track record of success in managing external CMC operations for biologic drug products.
Strong understanding of regulatory requirements for biologic products.
Excellent communication, collaboration, and problem-solving skills.
This position will be in our Watertown, MA office location.
Equal Opportunity Employer
Seismic Therapeutic is an equal opportunity employer. We will not tolerate discrimination on the basis of race, color, national origin, sex, sexual orientation, gender identity, religion, age, disability, veteran's status, pregnancy, genetic information or on any basis prohibited by federal, state or local law.
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