Executive/Senior Director of Analytical Development, Formulation Development, and QC

Location
San Carlos, California
Posted
May 18, 2022
Ref
4523145004
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Contract

Executive/Senior Director of Analytical Development, Formulation Development, and QC

Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.

Allakos is committed to developing innovative therapies that transform patients’ lives.  We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.

Position Summary:

The Executive/Senior Director of Analytical Development, Formulation Development, & Quality Control will be the functional lead and have primary responsibility for all activities associated with analytical method development/optimization/validation, quality control, formulation development, and stability testing of Allakos’ antibody drug substance and drug products. The successful candidate will work closely with Quality Assurance, Development/Manufacturing/Supply Chain, Project Management, and Regulatory Affairs to ensure timely formulation development and development & validation of methods as well as the timely testing and release of materials. This person will be responsible for the collection of data and the finalization of the reports and summaries required to support global regulatory submissions. In addition, this person will be responsible for establishing and maintaining excellent working relationships with multiple contract testing laboratories. Prior experience with method development/validation and the demonstrated ability to work effectively in an environment that utilizes contract testing laboratories for analytical development and quality control testing are requirements for this position. This position reports to the Senior Vice President of Process Development and Manufacturing.

Your Role:

  • Build and lead members of the Formulation Development, Analytical Development (AD) & Quality Control (QC) team. Establish adequate staffing to support aggressive growth plan.
  • Advance and manage Allakos’ product specifications, quality control system and stability testing
  • Oversee all activities associated with quality control and stability testing of Allakos’ pharmaceutical products at Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs)
  • Oversee activities associated with formulation development for Allakos’ clinical candidates.
  • Identify and address technical and validation gaps in analytical methods and QC testing in preparation for BLA/MAA submissions and product commercialization. Work with CTLs CMOs to devise and implement improvements in analytical methods
  • Identify, evaluate, and implement new analytical methods and quality control strategies
  • Ensure compliance of analytical testing activities with applicable compendia (eg., USP, NF, EP) and regulatory guidance documents
  • Coordinate and oversee analytical methods transfers to and between CMOs and CTLs
  • Manage the development and supplies of reference standards and critical reagents across testing sites
  • Contribute to or oversee the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results
  • Work collaboratively with Development/Manufacturing/Supply Chain, to ensure that QC analytical methods are aligned with process needs/capabilities and product requirements
  • Serve as primary author or reviewer of CMC sections related to pharmaceutical development, analytical methods and method validation, specifications, and stability in INDs, IMPDs, MAAs, BLAs, and other regulatory submissions
  • Lead a technical development team for an early stage project

Qualifications and Expertise:

  • Advanced degree (MS, PhD) in Chemistry, Biochemistry, Analytical Chemistry, or a related field preferred
  • At least 15 years relevant combined QC and AD experience. Previous 10 years of managerial experience required.
  • Experience leading Analytical Development team and working in partnership with process development team to deliver appropriate product control strategy
  • Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to development, testing and stability of pharmaceutical products
  • Experienced in all phases of biologics drug development is a plus
  • Ability to travel up to 10% 
  • Ability to effectively prioritize and demonstrated ability to deliver high-quality results on tight timelines
  • Excellent written and verbal communication skills
  • Accuracy and attention to detail
  • Excellent cross-functional team participation skills
  • Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues in a virtual environment
  • Willingness to work in a dynamic and changing corporate environment 

The salary is competitive and commensurate with experience and qualifications.

The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.