Director/Senior Director, Drug Product Development & Manufacturing

Summary:

Silverback Therapeutics, a Seattle-based biopharmaceutical company, is seeking a highly motivated individual to join our CMC team and contribute to development and manufacturing of ADC drug products. The successful candidate will provide strategic and technical leadership to the development and optimization of formulations and phase-appropriate drug product processes to support Silverback’s programs from pre-IND stage through late stage development, while ensuring uninterrupted clinical drug supply.

Responsibilities:

  • Manage external CMO to ensure quality, timely production and supply of drug product to support all pipeline programs.
  • Lead the development of formulations (liquid and/or lyophilized) for antibodies and antibody drug conjugates.
  • Oversee technical drug product process development and manufacturing of ADC drug product at CMOs, working with drug substance team to enable transition to drug product.
  • Guide development of early and late-stage drug product manufacturing process, including optimization, characterization, and validation.
  • Contribute to the design and development of stability programs to support shelf-life and distribution of drug product.
  • Provide insights to design manufacturability screen for assessment of potential development candidates.
  • Develop CMC plan in alignment with overall program strategy, and the requirements of pre-clinical and clinical teams.
  • Lead and coordinate with internal CMC and regulatory groups to establish specifications for drug product to support IND-enabling studies and late stage development.
  • Review and approve protocols, technical reports, batch records, change control process, manufacturing deviation investigations.
  • Review and provide oversight for CMC drug product process sections of regulatory documents.

Qualifications:

  • PhD or MS degree in engineering or life sciences, with 12+ years of experience in roles in the biotech industry requiring knowledge of biologic manufacturing processes, cGMP principles, and related FDA and other regulatory guidelines.
  • Experience in development of liquid and/or lyophilized formulations for protein therapeutics and/or conjugates.
  • Experience in process development, and clinical or commercial cGMP production of protein therapeutics and/or conjugates.
  • Experience with characterization and validation of commercial drug product manufacturing process for protein therapeutics and/or conjugates.
  • 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.
  • Flexibility 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 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.
  • 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 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 careers@silverbacktx.com. We are an equal opportunity employer.