Silverback Therapeutics, a Seattle-based biopharmaceutical company, is seeking a highly motivated individual to join our CMC product development team to support the development and manufacturing of antibodies at Contract Manufacturing Organizations (CMOs). The successful candidate will lead the cell culture development and manufacturing oversight functions at Silverback to support pipeline programs from pre-IND stage through establishment of commercial manufacturing.
- Guide the development of phase-appropriate mammalian cell culture process and scale-up activities at CMOs, balancing speed and quality.
- Lead the efforts on cell culture process characterization, process performance qualification and establishment of commercial manufacturing.
- Interface effectively with interdependent technical functions such as cell line development, purification, antibody conjugation and product analytics.
- In partnership with CMC colleagues, develop CMC plan to align with overall program strategy and to meet the requirements of pre-clinical and clinical teams.
- Review and approve protocols, technical reports, batch records, change controls, manufacturing deviation investigations.
- Lead and coordinate with internal CMC and regulatory groups to support IND-enabling studies and late stage development.
- Review and provide oversight for CMC drug substance process sections of regulatory documents.
- PhD or MS degree in engineering or life sciences, with 12+ years of relevant experience in the biotech industry in roles requiring knowledge of biologics upstream manufacturing processes, cGMP principles, and related FDA and other regulatory agency guidelines.
- Strong knowledge of GMP / ICH /EMA guidelines.
- Expertise and experience in development, characterization, and validation of commercial cell culture manufacturing processes.
- Proficient in statistical design of experiments (DoE) and data analysis.
- Experience with development and/or assessment of mammalian cell lines for production of proteins is a plus.
- Familiarity with antibody drug conjugates is desirable.
- Minimum of 5 years of management experience, including experience managing the work of other CMC internal, contract, and CMO staff.
- Detail-oriented while also retaining the ability to see the big picture.
- Flexible, results oriented and demonstrated ability to work in a fast-paced, timeline-driven environment.
- Excellent problem-solving and decision-making skills; provides strong critical thinking and constructive feedback.
- Proven ability to effectively communicate and collaborate with internal team and external collaborators.
- Will work tirelessly to foster an environment of transparency and direct dialogue.
- Ability to travel (5-10%) to domestic/international sites. Currently travel restrictions apply due to COVID-19.
- A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical needs.
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company leveraging our proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Our platform enables us to strategically pair linker-payloads that modulate key disease-modifying pathways with monoclonal antibodies directed to specific disease sites. Initially, we are creating a new class of targeted immuno-oncology agents that direct a myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. We are located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options. Qualified candidates should forward their resumes to email@example.com. We are an equal opportunity employer.