Director, Analytical DevelopmentQC
Job Location:
San Diego, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Job Title: Director Analytical Development/QC
Location: San Diego or Remote U.S.
Job Type: Full-Time
Who We Are
Avenzo Therapeutics Inc. (Avenzo or Company) is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics Inc. respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer. The Company is headquartered in San Diego California.
Position Summary
Reporting to the Senior Vice President CMC the Director Analytical Development/Quality Control (QC) will lead analytical strategy and execution across preclinical and clinical programs including method development and validation specifications release and stability testing impurity control and regulatory CMC documentation for drug substance and drug product. This handson leader will operate effectively in a lean environment and oversee outsourced analytical activities with strong technical judgment.
Essential Job Functions and Responsibilities
- Lead analytical development and QC testing for biologics programs from early development through commercialization primarily through external partners
- Drive analytical characterization to define molecular behavior structure-function relationships and impact on mechanism of action (MOA)
- Author and review analytical sections of CMC filings; communicate risks timelines and data interpretation to internal teams and external stakeholders
- Build and manage Contract Development and Manufacturing Organization (CDMO) and Clinical Trial Liaisons (CTL) partnerships using metrics to manage risk and drive performance
- Oversee analytical method development transfer validation verification and lifecycle management ensure robust compliant method across testing sites. Review validation strategies acceptance criteria and method trends to ensure methods are robust controlled and compliant across testing sites
- Provide technical and quality oversight for QC activities including raw material in-process release stability and special testing for drug substance and drug product
- Ensure QC operations comply with global regulations and internal standards; serve as escalation point for critical QC and compliance issues
- Review and approve investigations (e.g. OOS/OOT deviations data integrity) ensuring they are scientifically sound risk-based trending and have effective CAPAs
- Trend QC events to identify and resolve systemic issues
- Manage the lifecycle of reference standards and critical reagents including qualification potency assignment and requalification strategies and ensuring consistent execution across internal and external labs
- Oversee the global stability program specifications CoA and QC inputs to annual product reviews alignment to regulatory filings including protocol input and approval execution data review trend analysis and reporting to support filings shelf life and ongoing product verification
- Oversee annual product quality reviews related to QC data including OOS/OOT trends stability CoAs and release testing
- Ensure effective CoA generation review and approval for clinical and commercial materials with strong data integrity specification compliance and alignment to regulatory filings
- Oversee specification development approval and lifecycle management for drug substance drug product and combination devices ensuring scientific justification phase-appropriate criteria and alignment with regulatory commitments
- Support regulatory submissions audits and inspections as a QC SME
- Establish QC processes within the QMS (SOPs training change control and risk management.
- Contribute QC metrics trends and risk assessments to QMR and Quality Council forums
- Provide leadership mentoring and oversight of QC staff and external partners
Preferred Qualifications
- Bachelors degree in chemistry pharmaceutical sciences biology engineering required or a related area degree preferred (e.g. MS or PhD) with 10 years of progressive QC QA oversight of QC and/or analytical sciences experience in the life sciences industry or an equivalent combination of academic and industry experience
- Experience supporting small molecule biologics and/or combination device programs
- Strong knowledge of FDA EMA ICH EU GMP and global QC regulatory requirements
- Proven track record supporting regulatory inspections resolving complex QC compliance issues and applying risk-based approaches
- Experience with statistical analysis of analytical data and method capability with strong scientific judgment
- Deep expertise in analytical data interpretation method capability laboratory investigations and data integrity
- Ability to apply scientific judgment to data interpretation method performance issues and complex laboratory investigations.
- Strong organizational skills and the ability to manage multiple projects with competing timelines
- Ability to work effectively in cross-functional teams and independently in a remote setting as needed
- Excellent communication and interpersonal skills with the ability to collaborate effectively with internal and external stakeholders
- Strong analytical and problem-solving abilities with a strategic mindset
- This position requires periodic/regular travel including up to 10% of work time which may include overnight travel
Physical Demands and Work Environment
Physical Demands:
- Constant or continuous use of a computer keyboard monitor and mouse to perform a variety of tasks
- Constant or frequent sitting standing or walking
- May lift and/or move objects of various weights
Work Environment:
- Remote: Home office; expected to travel to and work from the Companys headquarters in San Diego from time to time
- San Diego-based: On-site requirement (Monday through Thursday)
- Noise level in the work environment is usually moderate
- Fast-paced time sensitive environment with frequently changing priorities
- Handle multiple projects simultaneously
Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.
Salary Range
The salary range for this position is $218000 to $233000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job and the industry education and skills and certifications.
Benefits
Provided they meet all eligibility requirements under the applicable plan documents employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical dental vision and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance flexible spending accounts health savings accounts and voluntary insurance programs including voluntary life AD&D accident and critical illness. Employees will also be able to enroll in the Companys 401(k) addition employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year including a winter closure subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies which may be amended from time to time.
Other Compensation
The hired candidate will be eligible to receive an annual discretionary bonus and an equity award subject to the terms of the applicable employment agreement plan documents and Company policies.
The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.
Applications for this position are anticipated to close on August 31 2026. For more information about this posting please contact.
Equal Employment Opportunity
Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individuals actual or perceived protected characteristic or characteristics or any combination of protected characteristics including race (including traits associated with race such as hair texture and protective hairstyles including braids locks and twists) ethnicity religion religious creed (including religious dress and grooming practices) color sex (including childbirth breast feeding and related medical conditions) gender gender identity or expression sexual orientation national origin ancestry citizenship status uniformed service member and veteran status marital status pregnancy age (40 and over) protected medical condition (including cancer and genetic conditions) genetic information disability (mental and physical) reproductive health decision-making medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act) the employee or their family members status as a victim of a qualifying act of violence political activity or affiliation use of cannabis off the job and away from the workplace association with an individual who has or is perceived to have a protected characteristic or characteristics or any combination of protected characteristics or any other protected status in accordance with all applicable federal state and local laws.
Notice to Search Firms/Third Party Agencies
Avenzo does not accept unsolicited resumes from recruiters employment agencies or search firms without a valid executed search agreement in place.
Required Experience:
Director
