Sr. Viral Vector Analyst, CMC

Immix Biopharma, Inc.; Los Angeles (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

The Senior CMC Consultant for Viral Vector Analytics at Immix Biopharma provides oversight of analytical strategy across clinical to commercial stages, focusing on retroviral vector analytics and lifecycle management from development to validation at CDMOs and CTLs.

The role liaises with manufacturing, process development, QA/QC, and program teams to deliver timely results, manage risk, and ensure compliant, efficient vector quality for patients and program milestones.

Qualifications

• Advanced degree (MS or PhD) in life sciences with 8+ years of applicable work experience in cell and gene therapy.
• Strong technical knowledge of retroviral vector analytics lifecycle (safety, potency, purity, identity, strength).
• Demonstrated hands-on problem-solving, assay troubleshooting, and investigations.

Responsibilities

• Provides oversight and leadership for the vector analytics program from clinical to commercial stages, aligning with objectives and timelines.
• Leads analytical method development and validation for retroviral vector programs (cell-based/molecular/microbial assays).
• Executes risk-based strategies for vector analytics integrated with manufacturing and product lifecycle.
• Leads planning and delivery of the vector stability program.
• Ensures timely issue resolution and strong collaboration with CDMOs/CTLs and cross-functional teams.
• Reviews analytical method qualification/validation documents and regulatory submissions support.
• Contributes to regulatory document sections as required.

Skills

Vector analytics lifecycle

Assay troubleshooting

Cross-functional communication

Problem solving

Data analytics

Education

MS or PhD in life sciences

Job description

The Senior CMC Consultant for Viral Vector Analytics provides key support for analytical strategy integrated with product development and launch programs . Primary accountability and focus on clinical and commercial retroviral vector analytical testing, enabling advancement of our innovative therapies and availability to patients. This role provides direct oversight, CMC technical expertise and management of viral vector analytical method lifecycle from development to validation and routine testing at CDMOs and CTLs.The Senior CMC Consultant for Vector Analytics acts as a key, solution-oriented liaison between Immix and CDMO/CTLs program teams and operates in a dynamic cross-functional environment including Manufacturing, Process Development, Quality Assurance, Quality Control, proactively managing risks and driving compliant, efficient, and predictable vector quality.

Key Responsibilities

• Provides engaged oversight and execution leadership for the vector analytics program from clinical to commercial stages, ensuring alignment with the strategic business objectives, compliance with lifecycle requirements, and program timelines.
• Leads the planning, execution and delivery of analytical method development and validation for the retroviral vector program based on demonstrated hands-on experience and expertise with various assays for in-process and vector product release testing (cell-based / molecular assays, microbial assays, etc)
• Proactively executes risk-based strategies for the vector analytics, integrated with the vector manufacturing and product lifecycle.
• Leads the planning, coordination, execution and delivery of the vector stability program
• Ensures timely issue resolution and execution of action items, enhances the partnership with the CDMOs/CTLs through broad and deep technical expertise, action-oriented cross-functional communication
• Collaborates with CMC functional areas to ensure successful execution and delivery of results.
• Reviews analytical method qualification and validation documents (protocols, reports, procedures, plans, investigation reports, etc) applicable to the product and process lifecycle.
• Supports authorship and review of pertinent sections for regulatory documents and submissions, as required.

Qualifications, Skills and Competencies

• Advanced degree (MS or PhD) in life sciences (molecular biology, biochemistry, , or a related life science field with 8+ years of applicable work experience in cell and gene therapy
• Strong technical knowledge and deep understanding of retroviral vector analytics(safety, potency, purity, identity, strength) lifecycle and requirements
• Demonstrated hands-on problem-solving skills, assay troubleshooting, investigations.
• Ability to work and communicate effectively across all levels, functions and organizations.
• Detail-oriented with strong data analytics skills.

Preferred Attributes

Experience working in a small or mid-sized clinical-stage biotechnology company where hands-on execution and strategic leadership are both required.

Comfort operating in a high-growth environment with evolving processes, shifting priorities, and visibility to senior leadership.

Compensation and Benefits

Immix Biopharma offers a competitive compensation package that may include base salary, performance-based bonus. Final compensation will be determined based on experience, qualifications, location, internal equity, and business needs.

Equal Employment Opportunity

Immix Biopharma is an equal opportunity employer. The company considers all qualified applicants for employment without regard to race, color, religion, sex, national origin, disability, veteran status, age, sexual orientation, gender identity, genetic information, or any other status protected by applicable law.