The Principal Technical Manager is a key member of the Hillsboro Innovative Therapies (HIT) team, responsible for the process development, manufacture, and supply of personalized immunotherapies in collaboration with our global partners. Additionally, this role is part of the consolidated analytical development team within the Pharma Technical Cell and Gene Therapy (PTC) organization dedicated to advancing therapies aimed at treating or curing various diseases.
The Opportunity:
In this role, you will lead and implement operational, analytical development, and quality control (QC) activities to support the clinical development of cell therapies. You will design, develop, and implement various analytical methods to enable the manufacturing of cell therapeutics. This position requires collaboration with technical development teams (TDTs), other PTC functions, and global teams to achieve rapid clinical proof of concept and readiness for commercial production.
As a Potency and Immunoassay subject matter expert (SME), you will play a crucial role in the design, development, qualification, validation, and transfer of potency and immunoassays to support GMP production. Your expertise will be pivotal in ensuring high-quality standards and compliance with regulatory requirements.
Apply advanced theory, technical principles, and expert judgment to develop and optimize potency and immunoassays
Design, develop, qualify, validate, and transfer potency and immunoassays to support GMP production
Write, review, and approve method development/qualification protocols and reports
Design experiments, capture execution, and report data in a lab notebook
Support product release and characterization by establishing and implementing SOPs and testing methods in full compliance with cGMP regulations and evolving expectations
Author CMC regulatory submissions to ensure they are accurate and fully aligned with governing SOPs and QC specifications
Provide technical input to ensure rapid resolution of any operational or technical issues.
Support internal and external audits and regulatory inspections
Who You Are:
Bachelor’s degree and 8 years of relevant experience OR graduate degree with 6 years of experience OR PhD with 3 years of experience. Preferred disciplines: Chemistry, Biochemistry, Molecular Biology or relevant scientific discipline
Experience is in the pharmaceutical or biopharmaceutical industry
Experience developing and qualifying potency and immunoassays (e.g. cytokine, cell killing, cell activation)
Sound knowledge of GMP, pharmacopeial, and regulatory guidance documents and considerable analytical/QC experience
Experience authoring test methods, technical reports, and regulatory documents
Professional level written and oral communication skills, ability to organize and present information in informal and formal group settings
Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical method development and qualification/validation
Preferred Experience:
Prior experience in cell therapy development
Flow cytometry, cell imaging, and cell culture experience
The expected salary range for this position based on the primary location of Oregon is $95,600 - 177,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Relocation benefits are approved for this posting.
This is an onsite role; remote or hybrid options are not available.
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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.