Associate Director, Quality Control

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Job description

TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Associate Director, Quality Control, to join our growing team. This role will oversee leading quality control activities, specifically in supporting the technical needs in the Quality Control Department. The role will work closely with Manufacturing, Quality, R&D, commercial, and our external customers, to develop, transfer, and sustain QC activities to help us take the next steps forward in our growth cycle.

Relocation and/or sign on available to non-local qualified candidates.

Responsibilities

* Establish and manage processes for method transfer, qualification, and validation from internal and external customers.
* Manage the implementation of analytical methods in the Quality Control Department to support business growth
* Propose new capital or resource investments to allow QC to keep up with the overall growth of the business
* Mentor young and growing team in best practices in analytical methods and science, under GMP and/or ISO considerations
* Author/review of technical protocols and reports to support methods qualification/validation
* Trending of quality control data
* Oversee the IO/OQ/PQ of analytical instrumentation and
* Assist Director in managing the assigned departmental budget and allocating resources per company objectives

Qualifications

* BS or higher in chemistry, biochemistry, molecular biology, bioengineering, or related field
* 7+ years of relevant life science industry experience
* 3+ years' experience with demonstrated skills in GMP and/or ISO, leading small teams of QC associates and/or scientists
* Experience in qPCR, Bioanalyzers, Fragmentation, and sequencing
* Experience with HPLC, chromatographic methods, and/or LCMS method development and execution
* Experience with method transfer of analytical or Bioanalytical assays preferred
* Experience with the method, spreadsheet, and software qualification and validation preferred
* Experience with equipment/enterprise system integrations such as LIMS integrations with laboratory equipment preferred
* Proficient in MS Office applications, such as Word, Excel, and Project
* Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements strongly preferred
* Strong multitasking abilities to complete activities in a fast-paced environment
* Ability to manage stress and balance competing demands in a high throughput environment
* Results-driven self-starter

TriLink BioTechnologies is a rapidly growing biotech firm in San Diego, CA, that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.

TriLink BioTechnologies is an EEO employer.