Job Description

This position is part of the consolidated analytical development team responsible for supporting the development of new modalities in the newly created Pharma Technical Cell and Gene Therapy (PTC) organization, the position is based in Hillsboro, Oregon. PTC focuses on the development of cell and gene therapies for the treatment or cure of various diseases. In this role, you will lead and execute operational, analytical development, and quality control (QC) activities in support of the clinical development of iNeST RNA/DNA vaccines and cell therapies.

As a member of the Hillsboro Individualized Therapies (HIT) Analytical Development and Testing (ADT) team, you will be implementing and maintaining lab systems to enable the CT manufacturing of iNeST DNA/RNA and cell therapeutics. You will help define the requirements for QC operations and establish processes to ensure production consistency and product quality. This role requires close partnership with PTC functions and global teams to achieve speedy clinical proof of concept and readiness for commercial production.

Primary responsibilities include management and administration of laboratory systems (e.g., LIMS, CDS, LES, etc.).

Responsibilities:

Support analytical method implementation and testing in partnership with MSAT, SSF development colleagues, Quality and other functions in PTC

Establish, implement and use SOPs, specifications, and testing methods in full compliance with cGMP regulations and evolving expectations

Serve as the Laboratory Systems Lead who owns the management and administration of ADT\xe2\x80\x99s laboratory systems

Build and test master data, deploy and maintain lab systems in compliance with regulations and SOPs

Provide technical input to ensure rapid resolution of any operational/technical issues (discrepancies and deviations)

Support root cause analysis (RCA) following the principle of investigating to the best of our capabilities, and subsequent implementation of corrective and preventive actions (CAPA)

Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by practicing experimentation and learning

Develop new business processes to constantly improve ourselves

Write, review or approve protocols and reports under limited supervision

Support internal and external audits and regulatory inspections

Define the user requirements for laboratory systems with the input from subject matter experts

Perform technical review of data and assess against established acceptance criteria

Identify discrepancies and provide input to the design of quality investigations and CAPA initiatives as needed

Participate in and/or lead project teams and process improvements initiatives

Provide input to set performance goals and departmental objectives

Establish work priorities to meet targets and timelines; manage competing priorities

Serve as the ADT representative on cross-functional and multi-site teams

Apply advanced theory, technical principles, and expert judgment to address a broad range of problems

Serve as a technical subject matter expert (SME) in support of department functions

Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

Perform any other tasks as requested by Management to support analytical activities

Qualifications/Requirements:

B.S./B.A. degree and eight years of experience or Master\xe2\x80\x99s degree plus six years of experience or an equivalent combination of education and experience. Degrees are preferably in Chemistry, Biochemistry, Molecular Biology or relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry

Sound knowledge of GMP and considerable QC experience

Experience managing and administering laboratory systems (e.g., LIMS, CDS, LES, etc.), including building and testing master data

Professional level written and oral communication skills, ability to organize and present information informal and formal group setting

Ability and willingness to take risks and make difficult decisions under ambiguity in order to deliver strong business results and achieve high productivity

Strong analytical intuition, troubleshooting skills and problem-solving capabilities

Work in an office and laboratory environment

Flexibility in problem solving, providing direction and work hours to meet business objectives

Demonstrated ability to work independently to accomplish tasks

Ability to sit, stand and move within work space for extended periods and lift up to 25 lbs

May be required to sit at a computer terminal or laboratory bench for extended periods

Ability to travel to other sites, as required

Relocation benefits are approved for this posting.

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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.

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