Sr. QC Pharmaceutical Specialist

Healthcare is becoming increasingly more targeted and the future of biologics manufacturing will need to support a more diversified portfolio serving smaller patient populations across multiple disease areas.

When our business is changing, we have to evolve in parallel. For the Roche Manufacturing network and drug product site Hillsboro Technical Operations, this translates into small to mid scale production and more agile manufacturing, filling and packaging of medicines. Along with the new technologies and products, work processes, health authority requirements and working methods will change and evolve. The level of automation and the use of robotics will increase. New skill sets will be required to work with various types of devices. Visual inspection and packaging will expand in variety and complexity. Aseptic filling in syringes and other formats will become the preferred solution for our patients convenience. Overall, we have to become faster and more efficient to deliver our future pipeline and contribute to the financial targets of our organization.

To realize the needs of the changing portfolio and to modernize operations, Roche has been investing in the Hillsboro Technical Operations (HTO) site; a manufacturing organization responsible for the reliable delivery of biologics drug product & finished goods, both for Roches commercial portfolio as well as launch products. Examples include: new small volume modular filler, new technologies such as a side loader cartoner and new facilities like solar field & power reliability. In addition, the QC laboratory expansion will complete in Q2 2025, and a new Direct Material (DM) Primary / Secondary Packaging QC testing lab and Stability Sample Storage Hub will be completed by the end of 2026. The overall investment decisions will exceed $100 million of investments to the site.

In a nutshell: As part of Roche's strategic initiative, the Hillsboro site is undergoing significant changes to adapt to the evolving landscape of biologics manufacturing. The focus is on enabling small to mid scale production, 2 new product transfers per year, and the integration of new technologies to meet the needs of a diversified product portfolio serving smaller patient

populations across multiple disease areas.

The Opportunity:

Are you looking to expand your experience with analytical, microbial or bioassay methods and contribute to the process of bringing these methods to the Quality Control Laboratory? The HTO Quality Control team is investing in our ability to bring current and new methods to the Quality Control Lab quickly and efficiently in a standardized and compliant manner. As a Senior QC Pharmaceutical Specialist I, you will serve as or support the analytical transfer lead on various Technology Transfer Projects. This position plays a meaningful role in establishing the validation history and maintaining the validated state of various test methods (bioassay, chromatography, microbiology and compendial assays, general chemistry) used to release our drug products or maintain our aseptic fill/finish manufacturing facility. This role serves as a technical authority and is expected to standardize work practices associated with method transfers, sustain the qualified state of these methods, and share their knowledge with junior associates to increase the overall technical capability of the Quality Control Organization.

Job Functions:

• You will lead or complete transfer of analytical, microbial and bioassay methods to and from the site by facilitating detailed gap assessments, defining clear and comprehensive transfer plans, completing the transfer activities per plan and summarizing transfer activities in collaboration with QC Operations, Quality Validation and other pharmaceutical Specialists from the donating and receiving sites.

• You will validate analytical, microbial and bioassay methods used to test and support the stability of pharmaceutical drug products in collaboration with network Product Control Strategy Scientists, Quality Validation, and QC Operations following standard operating procedures and industry standards.

• You will define, establish, standardize, implement and/or improve practices for maintaining the validated state of analytical, microbial and bioassay methods throughout its lifecycle through periodic reviews, monitoring, and re-qualification.

• You will serve as a site representative on network-wide technical method teams formed to discuss emerging issues through resolution, improve and standardize execution of current methods, and introduce technologies for performing these methods. The information discussed at these teams are routinely submitted via a sponsor to decision making bodies within the relevant/impacted functional areas including HTO. As a representative, you will be the voice for HTO and are accountable for ensuring information / decisions are disseminated to and from these teams.

• You will participate in Quality Control Investigations (e.g.: Out of Specifications, Out of Expectations, Over Action Limits, local and global process deviations) using established Root Cause Analysis tools and generating data-based impact assessments related to supported methods within established timelines.

• You will collaborate with key partners to identify and complete Corrective and Preventive Action Plans related to supported methods, completing assigned actions through self or others with tact and effective communication skills.

• You will author, review, and/or approve various business process & compliance related documents such as, standard operating procedures, work instructions, monitoring protocols, monitoring reports, gap assessments, and risk assessments related to the supported methods.

Who You Are:

Sr. QC Pharmaceutical Specialist:

• You hold a Bachelors of Science degree with 4-7 years of progressive experience in the pharmaceutical or scientific industry or 2-4 years of experience with a Graduate degree. 3 years of experience working in a cGMP or similarly regulated environment is required.

• You possess a deep understanding of analytical, microbial, or bioassay methods, method validation practices, regulations, and industry guidelines and consistently apply this understanding when performing your tasks.

• You are a strong problem-solver and have the proven ability to troubleshoot and resolve method-related issues.

• You have the judgment / discretion to raise matters of significance, ensuring efficient testing operations and regulatory compliance.

• You possess exceptional social skills and strong written and verbal communication skills. You use these skills to build effective cross functional teams and commit to timely informed decisions and completion of simple to moderate actions from others.

• You have a passion and ability for mentoring and inspiring others and are able to build/ maintain effective cross functional teams without direct management responsibilities.

Work Environment/Physical Demands/Safety Considerations

• You will be working on site in a flexible open space work environment with random visits to a QC laboratory environment that requires laboratory gowning (lab coat, goggles, gloves)

• You will work on/interact with computerized systems/screens for long periods of time (6-8 hours)

• You may be required to lift up to 25lbs

• You may have to work with hazardous materials and chemicals

Relocation benefits are available for this position.

The expected salary range for the Sr. QC Pharmaceutical Specialist based on the primary location of Hillsboro, Oregon is $67,400 to $125,200 . 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.

Link to Benefits

#gnehtoquality

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