About Us

Shattuck Labs, Inc. (www.shattucklabs.com) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, ARC®, platform simultaneously inhibit checkpoint molecules and activate costimulatory molecules within a single therapeutic. The company’s lead wholly owned program, SL-172154 (SIRPα-Fc-CD40L), which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in a Phase 1 trial. A second compound, SL-279252 (PD1-Fc-OX40L), is being evaluated in a Phase 1 trial in collaboration with Takeda Pharmaceuticals. Additionally, the company is advancing a proprietary Gamma Delta T Cell Engager, GADLEN™, platform, which is designed to bridge gamma delta T cells to tumor antigens for the treatment of patients with cancer. Shattuck has offices in both Austin, Texas and Durham, North Carolina.

 

About the Position

In this position, you will be accountable for the development of analytical methods, protein characterization, formulation development, and stability programs for DS & DP. You will lead a team to support and expand analytical development, formulation development and stability to help advance novel cancer therapies into human clinical studies. Furthermore, you should be hands-on and able to work independently, mentor junior associates, and provide insight to improve processes and communicate results in development team meetings. This position will report to the VP of CMC.

Summary of Key Responsibilities

  • Provides strategic leadership and technical expertise in analytical method development for release and stability testing of drug substance, raw materials, intermediates and drug product 
  • Identifies analytical science capabilities and technology tools needed to enable research, manufacturing, process development, QC testing, and new drug candidate formulation development
  • Applies scientifically-driven thinking to the development of scientifically sound, well understood, and robust analytical methods
  • Coordinates with other internal departments to review/approve qualification/validation of analytical methods
  • Leads analytical method transfer, qualification and validation to commercial QC and as needed for contract laboratories
  • Develop phase‐appropriate quality control strategy (partner with Quality) for drug substance and drug product
  • Manage product stability study programs
  • Leads development of scientifically sound and data driven specifications
  • Oversees analytical and QC activities at CDMOs and Contracting Testing Laboratories, including the review and approval of test records, forms, methods, protocols and reports
  • Prepares and delivers technical reports, documents, batch analyses, analytical methods, reference standard, etc. for regulatory submissions
  • Participate in drafting and reviewing of Module 3 for NDA and other regulatory filings as required
  • Publish or present scientific findings in peer-reviewed journals or conferences
  • Mentor junior associates and scientists

 

Required Qualifications

  • PhD in analytical chemistry, biochemistry, or protein chemistry with 7+ years preferred or BS/MS with 15+ years’ biologic (prefer proteins) molecule analytical development experience in the biopharma/pharmaceutical industry

 

Required Skills

  • Excellent scientific knowledge in analytical chemistry and protein chemistry
  • Strong analytical development knowledge/experience for drug substance and drug product
  • Ability to translate & develop research methods into qualified analytical assays
  • Effective verbal and written communication skills
  • Proven leadership of teams and developing people
  • Experience interacting with/managing CROs and CDMOs
  • Experience drafting analytical sections of INDs and NDAs
  • Knowledge of cGMP and applicable FDA, EMA and ICH guidance, and familiarity with the USP and other compendia.
  • Proven track record of understanding and (with Quality team) implementing phase appropriate quality control strategies
  • Ability and track record of successfully working in cross‐functional teams to progress projects as a representative of CMC team
  • Ability to navigate and be successful in a fast‐paced, matrixed work environment
  • Desire to be a part of a highly innovative company aimed at helping patients with serious diseases
  • A successful candidate must possess exceptional attention to detail, organizational, interpersonal, and communication skills, and demonstrate critical thinking and problem-solving ability
  • Must have the ability to multi-task to meet critical deadlines and the independent initiative to solve interdisciplinary problems
  • Candidate must be sharp, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential
  • Must enjoy working in collaboration with others and small teams to achieve goals through effective building of relationships with co-workers

 

 



 Note to External Recruiters: Our Human Resources department manages all open positions and candidate recruitment. We kindly ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. Please note that we will consider failure to comply with this request when determining whether to enter into a professional relationship with a recruiting agency. Please also note that submission of unsolicited resumes does not create any obligations for Shattuck Labs, implied or otherwise.