Silverback Therapeutics, a Seattle-based biopharmaceutical company, is seeking a highly motivated individual to join our regulatory and CMC development team and contribute to development and manufacturing of antibody drug conjugate (ADC) therapeutic candidates, including antibody and linker-payload intermediates. The successful candidate will develop and implement CMC regulatory strategy in support of Silverback’s programs from pre-IND stage through late stage development. This position will serve as the CMC regulatory lead on the technical teams for development products.
The Director, CMC Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Silverback Therapeutics drug products including, IND/Clinical trial applications and BLA applications, Health Authority responses and background packages (including participating in/leading CMC-specific HA meetings). In this role, the Director, CMC Regulatory Affairs represents Regulatory Affairs on the technical teams, participates in internal development team(s) and interfaces regularly with external CMOs.
This key role requires CMC regulatory expertise through all stages of a product’s lifecycle and develops global regulatory CMC strategies. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities. The individual also performs regulatory assessments of proposed manufacturing changes and provides guidance on regulatory expectations throughout development.
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
- Independently provide phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for ADC clinical trial applications and marketing applications for development projects.
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Independently manage and prioritize Phase 1 IND and late stage projects.
- Identify, communicate, and propose resolutions to both routine and complex issues.
- Interpret global regulations and guidance. Identify regulatory opportunity and risks across development lifecycle.
- Monitor regulatory developments within the industry and anticipate and communicate possible global regulatory paradigm shifts.
- Review and provide regulatory assessments for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
- Prepare and manage CMC submissions globally while ensuring thoroughness, completeness and timeliness working in collaboration with SME’s in Research, Process Development, Manufacturing, Quality and Supply Chain. Maintain responsibility for all CMC Regulatory timelines.
- Create and maintain regulatory strategy documents, including response strategy assessments for HA interactions.
- Manage relationships with diverse internal and external teams.
- Utilize electronic systems for dossier creation and tracking.
- BS/BA degree (or equivalent) in a relevant scientific field required, with a PhD in engineering or life sciences preferred.
- 10+ years of experience in roles in the biotech and/or pharmaceutical industry requiring knowledge of biologic manufacturing processes, cGMP principles, and related FDA and other regulatory guidelines, including 3 years of experience in management/leadership roles.
- 5-7 years of regulatory CMC experience required.
- Knowledge of CMC regulatory requirements across development stages and post-approval is essential. Experience with global CMC regulations for biologics is required; experience with antibody drug conjugates preferred.
- Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods.
- Demonstrated ability to: develop/maintain strong working relationships with the CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
- Detail-oriented while also retaining the ability to see the big picture.
- Flexible with 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 collaborate with internal team and external collaborators.
- Will work tirelessly to foster an environment of transparency and direct dialogue.
- A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical needs.
- This position may require up to 10% domestic travel and limited international travel (little travel is anticipated during the COVID-19 pandemic).
Silverback Therapeutics, Inc. is a privately held, clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTACTM technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback’s lead product candidate, SBT6050, is a therapeutic comprised of a TLR8 agonist payload conjugated to a HER2-directed monoclonal antibody that targets tumors such as certain breast, gastric and non-small cell lung cancers. SBT6050 is currently in a Phase 1 clinical study in patients with advanced or metastatic HER2-expressing solid tumors (ClinicalTrials.gov Identifier: NCT04460456). Silverback Therapeutics is 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 firstname.lastname@example.org. We are an equal opportunity employer.