Senior Engineer II, Manufacturing Science and Technology

Description:

Welcome to an inspired career.

At Halozyme Hypercon™, a wholly-owned subsidiary of Halozyme Therapeutics, Inc., 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 Senior Engineer II, Manufacturing Science and 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

Halozyme Hypercon is seeking a talented, enthusiastic, and experienced Senior Engineer II, Manufacturing Science and Technology to execute technology transfer and continuous process improvements for our patented and proprietary HyperconTM formulation process. This role reports to the Sr. Director, Manufacturing Science & Technology and will support the company with multiple technology transfers and routine manufacturing process support at global CDMOs and business partner manufacturing sites. This role operates will manage stakeholders cross-functionally both internally and externally. The work for this role is highly matrixed with the complexity of working on several technology transfer programs in parallel as the company executes the 5-year manufacturing strategy for projected growth. The role will serve as an interface between Program Management, Analytical & Process Development, Quality, Supply Chain, Engineering, and Manufacturing for internal, partner, and CDMO stakeholders. The role will participate in cross-functional teams to successfully accomplish goals and objectives, while continuously improving manufacturing supply and process performance. Global travel up to 25% of time may be required during start-up of new manufacturing sites to support technology transfer and batch manufacturing. Lean six sigma methodologies will be leveraged to create, implement, measure, and report on key performance indicators (KPIs) for manufacturing performance. The individual should thrive in a fast-paced and dynamic environment and be a key player in the company’s growth. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals.

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

• Perform all duties according to the company’s core values, policies, and applicable regulations.
• As a member of the MS&T Team, be a change leader to develop and implement innovative approaches to meet the challenges of the rapidly growing business.
• Responsible for technology transfer execution and routine manufacturing support for bulk aseptic formulation and filling processes from Phase I clinical through commercialization.
• Create technology transfer plans, campaign summary reports, process change documentation to support change controls, and CMC support documentation.
• Lead and own process and manufacturing risk assessments with mitigation action plans.
• Review engineering drawings, P&IDs, automation control modules, batch records, process control and validation strategies.
• Partner closely with stakeholders to ensure internal & external production plans and capacity are aligned with clinical demand needs.
• Support manufacturing network during regulatory site inspections.
• Partner with PM and IT functions to implement new technologies for data analysis and process monitoring

Requirements:

To succeed in this role, you’ll need:

• B.S. Degree in Engineering/Sciences is required; Advanced M.S./PhD degree in Engineering is a plus consideration.
• Minimum of 8 years of experience working in a cGMP/cGCP environment is required, preferably working in biologics or cell & gene therapy within the biopharmaceutical industry. Preferred experience should be a combination of work experience in Manufacturing, MS&T, Technical Operations, and/or Development.
• Minimum of 5 years supporting process technology transfers and new manufacturing site start up is strongly preferred.
• Minimum of 5 years of experience with aseptic bulk formulation and filling processes for monoclonal antibodies (mABs), antibody-drug conjugates (ADCs), antibody oligonucleotide conjugates (AOCs), vaccines, and/or cell & gene therapies.
• Having both bulk drug substance and aseptic drug product experiences is a plus consideration.
• Shown ability to inspire change and build new processes within a diverse and matrix organizational environment is required.
• Advanced manufacturing and technical acumen with ability to influence and direct stakeholder decis