Senior Engineer 2, Manufacturing Science

2 days ago

San Diego, United States Halozyme Full time

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We look forward to discovering your talents.

Welcome to an inspired career.

At Halozyme, we're proud of what we do, and we continue 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 Engineer 2, Manufacturing Science & Technology and you'll 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 Engineer 2, MSAT is a key contributor in one or more fields of protein process technology transfer, laboratory management, scale-down study design and execution, process validation, and large-scale drug substance manufacturing. In this role, you will lead scale-down downstream laboratory operations and reporting to support process characterization, continuous improvement, quality investigations, and patent generation. You will support the technology transfer of data, processes, and technical specifications to contract development and manufacturing organizations (CDMOs) and the implementation of scale-up manufacturing operations for clinical and commercial production.

In this role, you'll have the opportunity to:

  • Perform scale-down experiments to support data generation or manufacturing issue resolution

  • Maintain laboratory inventory, equipment, and procedures in a state of readiness to implement upon strategic plans

  • Lead the identification and implementation of process improvements in productivity, reliability, and yield while maintaining product quality attributes

  • Lead the development and transfer of manufacturing unit operations and associated control strategies for drug substance processes

  • Author study plans, study protocols, data presentations, study reports, and technical assessments

  • Support process scale-up, production, process monitoring, technology transfer documentation, and process validation activities at CDMOs

  • Author procedures, work instructions, and process training aids describing essential functions or best practices

  • Interact with CDMOs and other third-party service providers

  • Occasional weekend work is required

To succeed in this role, you'll need:

  • BS degree in a physical or life science with a minimum of 8 years of experience (an equivalent combination of experience and education may be considered)

  • Proficient in downstream/purification of biologic proteins including chromatography, virus filtration, tangential flow filtration, normal flow filtration, and buffer preparation.

  • Proven technical expertise and experience in the manufacturing and process development of biopharmaceutical products

  • Advanced skills in building and maintaining positive relationships with internal and external collaborators, including Analytical Sciences, Quality, Regulatory Affairs, Supply Chain, and Project Management

  • Depth of knowledge of both scale-down and manufacturing scale downstream process equipment required

  • Working knowledge of process control systems (e.g., Unicorn, PID controllers, Delta V, etc.) is strongly preferred

  • Knowledge of software required: Statistical analysis and data trending software (JMP, Minitab, Tableau or equivalent), Smartsheet, Microsoft 365.

In return, we offer you:

  • Hybrid work flexibility-must work on site Tuesday - Thursday

  • Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.

  • Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.

  • 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 annual salary for this position is between $111K - $166K 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.

AccessibilityandReasonableAccommodations:
Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at hrbox@halozyme.com.

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