Aro Bio Therapeutics

Join the team at Aro Biotherapeutics creating breakthrough biotherapeutics based on Centyrin oligonucleotide conjugates. Centyrins are small protein domains based on the fibronectin domains of human Tenascin C that combine the affinity and specificity properties of antibodies with the stability and tissue penetration properties of small molecules. We have engineered Centyrins with an array of specificities for normal and immune cell receptors. By linking Centyrin domains together genetically, we have created multi-specific binders that retain a small footprint to enable excellent tissue penetration. Engineered for high stability, multi-specific Centyrins are readily expressed and purified from E. coli or mammalian cells.

We are developing a platform for delivery of an array of intracellularly active payloads with a focus on oligonucleotides. Our team has built a strong set of in vitro and in vivo data validating the utility of Centyrins for receptor specific uptake in a variety of cell types. Centyrin conjugate mediated delivery provides the foundation for access to a set of intracellular targets that have long been considered undruggable.

Aro is building a wholly owned portfolio of Centyrin oligonucleotide conjugates for genetic and autoimmune diseases and developing a partnered portfolio of Centyrin conjugates for payload delivery in a variety of disease areas. Led by an experienced and exceptional team, Aro is backed by an exceptional syndicate that supports our commitment to advancing drug candidates with the potential to improve patient’s lives and to building an ideal environment for scientific and leadership growth.

The Associate Director/Director Analytical Development and QC will be responsible for leading Analytical development, method qualification/validation and QC testing supporting Aro’s first Centyrin – siRNA drug conjugate clinical program. Aro’s lead program is currently in early development and poised to start manufacturing and early safety studies. The position requires previous direct experience in Analytical development function supporting Biologics or Antibody-drug conjugate drug substances, and drug products. The successful candidate will have strong interpersonal skills and a passion for the development of a new, highly innovative platform as well as strong leadership skills to build and lead an internal team of analytical scientists. In a growing and fast-paced environment, this individual must exhibit nimbleness, a willingness to step outside his or her comfort zone, a dedication to constant learning and personal development and thrive in a team environment.

Responsibilities

  • Provide leadership in analytical development and QC testing for oligonucleotide API, recombinant protein API, oligonucleotide-protein conjugate drug substance, and oligonucleotide-protein conjugate drug product
  • Contribute to the overall CMC strategy of drug development and put together analytical strategy and tactical plans
  • Develop phase-appropriate quality control strategy for intermediates, drug substance and drug products
  • Manage analytical method development and method qualification/validation for oligonucleotide API, recombinant protein API, and oligonucleotide -protein conjugates at CROs/CDMOs to support development work, toxicology and clinical studies
  • Direct analytical development and method transfer activities at CDMOs including identification of impurities and degradation products, binding and cell based bioassays, reference standard qualification and other characterization methods
  • Manage nGLP, GLP, and GMP stability programs within Aro Biotherapeutics and across CDMOs and CROs
  • Review release/stability testing data at CDMOs
  • Build internal analytical team and provide analytical support to internal/external development activities
  • Author analytical development reports and analytical related sections of IND/CTA/BLA
  • Identify and manage CDMO, CRO to accomplish analytical milestones
  • Identify and manage analytical consultants
  • Contribute to internal quality systems development and implementation (i.e. SOP, training)
  • Serve as the Analytical Development (AD) subject matter expert and AD lead on CMC cross functional project teams
  • Hire, supervise and coach analytical scientists
  • Collaborate with external CDMOs and internal partners to prepare analytical development plans and data to ensure timely delivery of nGLP, GLP Tox, GMP clinical, and commercial supplies as well as key technical studies to meet CMC timelines
  • Ensure key CMC functional documentation is completed to meet project plans (i.e. method development & qualification reports, justification of specifications, CoAs, CQA reports, etc…)
  • Timely communication and escalation of project issues
  • This position reports to the Head of CMC and is located in Philadelphia, PA

Qualifications

  • PhD. in analytical chemistry or equivalent with 7+ years of experience in analytical development/QC of biologics (antibody-drug conjugate experience preferred) and small molecule (oligonucleotide preferred) intermediates, drug substance and drug product
  • Excellent scientific knowledge of modern analytical methodologies for biologics and working knowledge of organic chemistry
  • A proven track record of implementing phase appropriate quality control strategies
  • Direct experience in managing analytical development/QC activities at CROs and CDMOs
  • Experience in authoring analytical related sections of INDs and NDAs
  • Working knowledge of GLP, cGMP regulations and ICH guidelines as well as pharmacopeia standards required; experience working in a cGMP QC environment highly desirable
  • Strong problem-solving and troubleshooting abilities
  • Strong organizational skills
  • Effective verbal and written communication skills
  • Experience managing multi-disciplinary CMC team projects that include external contract development and manufacturing organizations, contract research organizations, and consultants supporting CMC development & manufacturing
  • Ability and track record of successfully working in cross-functional teams to progress projects
  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment
  • Strong written and verbal communication skills are essential
  • Experience accomplishing goals and timelines through cross functional matrix teams
  • Demonstrated ability to be creative and take a proactive approach to team building and problem solving
  • An understanding of GLP and GMP requirements for IND enabling studies and a strong background in the steps required for development of biologic and/or nucleic acid therapeutics
  • Ability to multi-task in fast-paced start-up environment

Aro Biotherapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity/gender expression, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Aro Biotherapeutics offers a competitive benefits package including:

  • A variety of health insurance options at competitive rates
  • Flexible Spending Accounts
  • Paid Time off, including personal and vacation time
  • Company holidays
  • 401(k) with company match
  • Disability and Life Insurance
  • Commuter Benefits
  • Employee training and development opportunities
  • And more!