Senior Manager, Quality Control

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Senior Manager, Quality Control

Welcome to an inspired career

At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do, and we need innovative, strategic problem solvers who drive business results by adopting the collective attitude necessary to make our ONE TEAM culture thrive. We embrace open, honest and transparent communications to help us achieve collective win and we constantly strive to do more. That's why we need you-to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo and advancing our mission.

Join us as a Senior Manager, Quality Control and you will be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people's lives.

How you will make an impact

The Senior Manager, Quality Control provides a full range of Quality Control (QC) activities supporting Halozyme's BioPharma stability programs. The range of functions spans commercial, clinical, and development products and programs in support of our partner relationships and internal programs. The position is pivotal to the strategy and execution of Halozyme's product and program objectives, and requires individual and team leadership, and cross-functional collaboration.

In this role, you will have the opportunity to:

• Lead and Manage the Stability Program:
  • Author, Review and approve stability protocols and reports
  • Accountable for stability data and data trending analysis
  • Perform technical data assessment for stability monitoring and perform statistical analysis
  • Author and review of stability sections for regulatory filings; apply solid understanding of regulatory requirements for FDA and global Health Authorities' requests for information
  • Ensure compliance with ICH, ISO, FDA, EU and other regulatory agencies
  • Contribute to annual budget planning, manage POs, approve invoices, and monitor spending throughout the year
  • Responsible for shelf-life extensions and evaluation of stability acceptance criteria
  • Lead strategy for program improvements

* Oversight and Management of Stability testing at internal and external laboratories:

• Ensure stability testing compliance with adherence to test methods, stability protocols, and to regulatory submissions
• Provide strategy and oversee execution of special stability studies
• Collaborate with technical team with stability input on investigations for aberrant results, OOT, and OOS results; provide impact assessment for excursions

* Support CMC teams in aspects of technology transfer, process scale-up, comparability, and process validation activities at CDMOs

To succeed in this role, you will need:

• Bachelor's degree with a minimum of 8 years of related experience and previous experience working in the pharmaceutical industry in QC (an equivalent combination of experience and education may be considered)
• Solid background in analytical chemistry across a wide range of technologies (HPLC, CE, MS, etc.) and previous experience working in the pharmaceutical or combination product industry
• Expert writing and reviewing regulatory filings skills with a strong understanding of regulatory requirements
• Proven experience leading stability programs
• Detailed understanding of GMPs, ICH, ISO, and regulatory guidelines
• Working knowledge and experience in QC assay development, qualification, and validation is desirable
• Validated ability to work closely with internal departments, partners and CDMOs including senior management on significant matters concerning projects and commitments
• Knowledge of statistical software required: Adobe, JMP, Tableau, Microsoft applications
• Previous experience in working with external parties (CDMOs, Contract Labs) is preferred

In return, we offer you:

• Hybrid work flexibility-must work onsite Tuesday - Thursday
• A collaborative, innovative team that works as one to amplify your impact-on your career, the work you do and patients' lives.

Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

The most likely base pay range for this position is $120K to $180K annually. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual's exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.