Senior Engineer 2, Process Development
Job Description
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Senior Engineer 2, Process Development-San Diego
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 constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team - we rise by lifting others up and believe in the power of working together for the collective win. That's why we need you-to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.
Join us as a Senior Engineer 2, Process Development 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, Process Development is a key contributor in one or more fields of protein process technology transfer, laboratory management, small-scale study design and execution, process validation, and large-scale drug substance manufacturing. This position leads day-to-day small-scale upstream laboratory operations and reporting to support process characterization, continuous improvement, quality investigations, and patent generation. The position supports 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:
- Maintain laboratory inventory, equipment, and procedures in a state of readiness to implement upon strategic plans
- Complete scale-down experiments to support process data generation or manufacturing troubleshooting activities
- Lead the identification and implementation of process improvements in productivity, reliability, and yield while preservice 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
- Interacts with CMOs 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 upstream/cell culture production of biologic proteins including aseptic technique, mammalian suspension cell culture, fed batch processes, media preparation, 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
- Knowledge of equipment required: Strong knowledge of an area specific (i.e., cell culture or chromatography) of manufacturing and analytical equipment required: familiarity with a broad range of automation controls and manufacturing control systems desired.
- Knowledge of other equipment desired: Solid understanding of process control systems (e.g., PID controllers, Delta V, Unicorn, etc.) is strongly preferred. Working level knowledge of statistical software is desired.
- 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-requires 3 days weekly to work on site and more as needed
- 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 base pay range for this position is $111K to $166K per year. 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.
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