To meet our strategy of rapidly advancing our novel products into clinical trials and beyond, we seek the services of an Analytical Sciences expert to lead critical activities within the CMC function. Reporting to the Senior Vice President, Head of CMC, the Director of Analytical and Formulation Development will provide guidance and oversight for all aspects of analytical development, formulation development and GMP testing at contract development and manufacturing organizations (CDMOs). This includes ensuring adherence to technical plans, project timelines and budget at CDMO sites for timely execution of method development and qualification, product and impurities/variants characterization, quality control testing, and the development of new and optimized formulations. The Director of Analytical and Formulation Development will work both independently and with cross-functional teams to provide high-quality support of multiple therapeutic projects. The position will function remotely, with occasional travel to Attralus’ San Francisco Bay Area home office, along with onsite visits to contract laboratories as appropriate and safe.


ROLES, RESPONSIBILITIES & EXPECTATIONS 

  • Provides scientific expertise to design and implement innovative yet efficient solutions for the analytical testing and characterization of novel therapeutics, solving challenges and ensuring that project deliverables meet aggressive timelines.
  • Manages analytical and formulation development activities, including, but not limited to: supporting requests for proposals for analytical and formulation services; participating in review and approval of contracts, work orders and change orders; supporting design and scheduling of CMC development activities and GMP testing of Drug Substance and Drug Product.
  • Serves as a scientific/technical point of contact to CDMOs regarding the following: analytical method development and qualification/validation, analytical support of process development, formulation and drug product development, reference standard selection and qualification, critical reagent sourcing and evaluation, product and impurities characterization, analytical testing review, OOS/OOT/deviation investigations, and stability studies.
  • Manages relationships with scientific and operational counterparts at contract facilities, including communication and technical oversight, to meet accelerated timelines and to ensure timely delivery of materials to support IND-enabling studies and activities.
  • Serves as an author on regulatory filings and external communications as a subject matter expert on analytical sciences, formulation development, and GMP testing.
  • Collaborates with CMC teammates to support pre-clinical and clinical supply chain, including analysis and documentation of samples, reagents, intermediates and finished products.
  • Ensures product integrity through diligent assessment of GMP compliance.
  • Manage technology transfer between contract organizations and collaborators, ensuring effective information flow, timeline execution, issue resolution, training, and documentation in accordance with governing quality system requirements while leveraging robust risk management practices.
  • Travels to contract facilities or business partners, both domestic and international, as required.
  • Works on cross-functional teams to ensure effective communication between Attralus and its CDMOs and suppliers, and keeps internal stakeholders appropriately informed with CMC activities.
  • Supports adherence to budgets, project plans, and performance requirements.


REQUIREMENTS/QUALIFICATIONS

  • BS/MS/PhD in Biochemistry, Biology, Immunology discipline or equivalent with 12 to 15 years of experience in the biotechnology or pharmaceutical industry
  • Broad and extensive experience in recombinant protein method development, characterization, and GMP testing (lot release and stability) is essential
  • Experience with oversight of analytical method development by or transfer to contract service providers is highly desirable 
  • Experience in the establishment of GMP product specifications is preferable
  • Experience in the design and management of IND-enabling stability studies is highly desirable
  • Previous authorship of CMC sections of regulatory filings associated with therapeutic proteins is highly desirable
  • Experience with formulation development and/or GMP drug product manufacturing is a plus
  • Strong understanding of cGMP, FDA and EMA guidance, ICH guidelines, and is preferable
  • Experience in drafting requests for proposals, review of work orders and change orders, and maintenance of budgets for analytical and formulation services is a plus 
  • Excellent written and verbal communications skills, both internal and external, are essential 
  • Must have prior success in collaborative teamwork, including both remote and face-to-face interactions 
  • Project management and/or multidisciplinary team leadership experience is a plus
This position has been filled.