Senior Associate I, Quality Control

Job Description

Job Description

What We Do:

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the utilization of oncolytic viruses through an allogeneic cell-based delivery system. Calidi Biotherapeutics is advancing this potent stem cell and oncolytic virus combination for use in multiple difficult-to-treat oncology indications. Our team is also developing a universal cell delivery system to protect, amplify, and potentiate oncolytic viruses currently in development.

Job Overview/Summary:

The Senior Associate I, Quality Control contributes to the quality of Calidi’s products and processes by overseeing external laboratory testing of GMP materials. This includes assurance that laboratory results are timely, reliable, and in accordance with all applicable regulatory requirements and internal procedures. This role collaborates cross functionally to develop, transfer, and qualify analytical methods, maintain global GMP inventory, qualify new suppliers, and support the strategic leadership of daily QC operations. Additionally, this position has supply chain tasks for inventory, clinical trial distribution, and sample logistics in compliance with regulatory standards. Ensures timely and efficient delivery of pharmaceutical products and materials across global operations while maintaining quality and traceability.

Responsibilities:

• Oversees external laboratory testing of GMP starting materials, in-process, release, and stability samples to ensure testing is performed in accordance with applicable internal procedures and specifications.
• Reviews and approves QC procedures, test results, reports and production batch records. Conducts investigations into any out-of-specification results or laboratory deviations.
• Implements appropriate corrective and preventive actions to address root causes and prevent recurrence.
• Coordinates contract laboratory vendors, monitors laboratory performance, assesses capability, and ensures actions are taken to improve, as needed.
• Troubleshoots challenges while fostering a collaborative approach with external partners to support seamless and reliable QC operations.
• Coordinates the stability testing programs for GMP materials, including reviewing stability data and reports, comparing test results against stability specifications, and establishing retest dates as appropriate.
• Builds and maintains expertise in QC analytical processes and methods critical to oncolytic virus and cell therapy product development, manufacture, characterization, and release.
• Supports development of test methods and procedures.
• Facilitates method transfer from internal development to external partners, including overseeing laboratory testing during method qualification and validations activities.
• Collaborates with Manufacturing to ensure incoming raw materials and components meet necessary quality requirements.
• Works with Quality Assurance and external vendors to qualify new suppliers, implement appropriate sampling and testing of incoming materials, and review supplier-provided quality documentation.
• Inventories GMP products and materials, including reference standards and critical reagents used in routine testing.
• Prepares and maintains appropriate permits and documentation to support global shipment of regulated materials.
• Provides CMC support on product development efforts related to formulation development, drug delivery device, container closure selection, packaging and labeling.
• Collaborates with internal and external Manufacturing, Quality Assurance, Regulatory Affairs, and Development teams to support overall CMC activities of projects in the pipeline.
• Participates in cross-functional meetings to address project timelines, tech transfer, and align on project objectives.
• Plans and implements continuous improvement of methods, processes, and systems to assure compliant manufacturing of products.
• Addresses inventory levels across multiple sites, ensuring accuracy, availability, and compliance with GMP/GDP standards.
• Guides domestic and international shipping of products and ensure chain of custody, proper handling, storage, and transportation of temperature-sensitive and controlled substances.
• Coordinates clinical trial material distribution, including investigational medicinal products and material supply as needed.
• Leads sample logistics processes, including biological sample tracking, shipment coordination, and chain-of-custody documentation.
• Develops and support all SOPs and procedures required to perform tasks related to supply chain
• Inform Technical Operations leaders as to progress, barriers/issues needing resolution and maintenance of timelines.
• Other duties as assigned.

Qualifications:

• BS or higher degree in Life Sciences, Chemistry, or a related field (e.g., Chemistry, Biology, Immunology, Microbiology) and formal training in cGMP, cGCP, cGLP, regulatory requirements
• Minimum of 5 years of experience in a QC role in a GMP manufacturing environment.
• Proven track of supply chain activities.
• Broad knowledge of QC processes and procedures, LIMS systems, and GMP regulations and guidance with demonstrated effectiveness in maintaining QC processes for compliance with regulations.
• Excellent organization and project management skills.

Mathematical Skills:

• Ability to work with mathematical concepts such as calculation of dilutions and statistical analyses.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

• Ability to define problems, collect data, establish facts, and draw valid conclusions.

Language Skills:

• Ability to read and understand technical procedures.
• Ability to write protocols and reports.
• Ability to effectively present data and respond to questions from co-workers.
• Good verbal and written communication skills.

The Perks:

• Breakroom snacks and beverages
• Competitive Total Rewards package (Medical, Dental, Vision) offered to full-time employees
• Stock options

Work Location:

Calidi Biotherapeutics employment provides the opportunity to work in beautiful San Diego, California only minutes from the nearest beach.

EOE and Accommodation

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. Calidi Biotherapeutics provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may let the recruiting contact know. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives:

Calidi Biotherapeutics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Calidi Biotherapeutics employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Calidi Biotherapeutics. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Employer’s Rights:

This job description does not list all the duties of the job. You may be asked by supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description.

The employer has the right to revise this job description at any time. The job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason.