Associate Director Analytical Development and Quality Control

Location
Redwood City, CA
Posted
Oct 06, 2021
Ref
4107528004
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Contract

Associate Director, Analytical Development and Quality Control

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:

As a member of the Allakos team you will have the opportunity to be a key member of the Analytical Development and Quality Control (ADQC) group and responsible for setting up a “central QC lab” in a contract testing laboratory (CTL) for our late-stage clinical biologic (Mab) molecule AK002.  The incumbent will set up the analytical programs in the CTL, oversee the method transfer and validation for product licensure or post-approval change to the testing site, manage the routine and stability testing accordingly.  Additionally, there will be a strong focus on BLA or sBLA activities including analytical support for PPQ, product characterization, comparability studies, specification setting, and regulatory document writing and review.

The position will focus on the drug product (DP) testing initially and may further support the drug substance (DS) in the future. The incumbent is expected to drive and own the assigned activities to meet project timelines and work closely with cross-functional teams. This position will report to Director, ADQC.

Primary Responsibilities:

  • Plan and execute the “central QC lab” strategy under aggressive timeline for AK002 DP release and stability testing.
  • Oversee the remaining DP testing performed by the DP contract manufacturer, support the DP manufacturing and development team in various activities including DP lifecycle management as the analytical lead.
  • Own the assigned projects with hands-on responsibility. Review and approve relevant analytical study protocols and reports.
  • Manage the analytical method transfer, validation, reference standard qualification, stability, specification, analytical comparability, assay troubleshooting, QC deviation, change control, etc.
  • Escalate significant issues to the ADQC Director and/or relevant project teams in a timely manner and drive the mitigation or problem-solving activities.
  • Identify areas for improvement across the QC testing network and Allakos ADQC team, align and implement the improvements internally and externally.
  • Build collaborative relationships with other stakeholders including DS and DP Manufacturing, Process Development, Site Manager, Tech Transfer Lead, Quality Assurance and Regulatory Affairs. Adjust and align on the roles and responsibilities across different functions as needed.
  • May support the Module 3 BLA and IND writing or review based on the area of expertise.
  • Travel domestically and internationally up to 10% of the time.

Qualifications:

  • At least 12 years of relevant experience (10+ with M.S., 8+ for Ph.D.) successfully working in the biopharmaceutical industry with proven track record of leadership and success.
  • At least 5 years managing cross functional projects and leading teams.
  • Extensive experience in analytical transfer and validation, product characterization, stability, and QC cGMP activities for biologics, such as Mabs and recombinant proteins.
  • Strong background in method validation, transfer, verification, qualification, bridging studies, stability trending, OOS closure, etc.
  • Experience working with CTL is preferred.
  • Experience in DP manufacturing, prefilled syringe or autoinjector development is preferred.
  • Experienced in BLA authoring and review is a plus.
  • Experienced in people and stakeholder management, conflict resolution, and building consensus.
  • Good understanding of cGMP-regulations including relevant US/EU regulatory and quality requirements, practices, and standards.

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.