Director, Process Engineering (Parenterals)

 Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products.  The Operations organization at HTO is divided into 2 value streams, which produce millions of units of life-saving medicine every year for patients around the world.

The Opportunity:

This exciting role resides in the Parenteral Launch and New Technology Value Stream (PLaNT) organization and  is responsible for introduction of new products (technical transfers), implementation of new technologies and end-to-end process engineering support at our manufacturing site in Hillsboro, OR.

As the Head of the Process Engineering in PLaNT organization, you will be lead a team of motivated Parenteral Process Engineers who provide technical expertise for Make-Assess-Release (MAR) of commercial products, commercial technical transfers, and implementation of new technologies including process validation, and authoring, reviewing and approving Health Authority submission documents. 

• You’ll build and lead an empowered team of Process Engineers responsible for providing technical expertise to support MAR, technical transfers and new technologies.

• You’ll collaborate with technical experts and leaders across PT to ensure our standard of excellence.

• You’ll help establish  HTO as a center of excellence for Drug Product Manufacturing including all unit operations such as drug substance thawing, filtration, filling, lyophilization and crimping for vial and prefilled syringe products.

• You’ll partner with Manufacturing and Quality to create an environment conducive for efficient  manufacturing execution and continuous improvement.

• You’ll support product launches through all stages of Regulatory relevant activities, including successfully managing  inspections. 

Who you are:

• You have a Bachelors degree in Pharmaceutical Sciences, Life sciences, Engineering

• You have deep, relevant bio/pharmaceutical experience (15+ years), including significant cross-functional and direct group management, ideally in manufacturing, 

• You are an exceptional leader—able to inspire and motivate teams to make a big impact and deliver their best every day. 

• You have expertise in sterile process development and familiarity with Parenteral manufacturing equipment including: isolators, filling machines, lyophilizers, and crimping machines.

• You are a strategic and systems thinker with a compliance focus, anticipating technology trends and driving excellence in execution.

• You have experience in working in an FDA regulated environment in a Parenteral facility, deep knowledge of cGMP and Regulatory expectations for Pharmaceutical products. 

• You demonstrate creative leadership skills as a Visionary, Architect, Catalyst, and Coach (VACC), removing barriers, developing people and technical capabilities, and creating an environment for high performance.

• You are able to navigate and influence, embracing agile ways of working and leveraging lean tools and methodology, building networks and collaborating across organizational levels.

• You have experience  supporting the advancement of diversity, equity, and inclusion.

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $137,000 - $256,000.  Actual pay will be determined based on experience, level, 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.

Link to Benefits

Relocation benefits are provided

#gnehtoengineers 

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.