Senior Engineer II, Manufacturing Science and Technology
About the role
Halozyme Hypercon™, a wholly-owned subsidiary of Halozyme Therapeutics, Inc., is reinventing the patient experience and building the future of drug delivery. We are 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 Hypercon™ formulation process. This role reports to the Sr. Director, Manufacturing Science & Technology and supports multiple technology transfers and routine manufacturing process support at global CDMOs and business partner manufacturing sites.
The role operates in a highly matrixed environment, managing stakeholders cross-functionally both internally and externally, and involves working on several technology transfer programs in parallel as the company executes its 5-year manufacturing strategy for projected growth. Global travel up to 25% may be required during start-up of new manufacturing sites to support technology transfer and batch manufacturing.
Responsibilities
- Perform all duties according to the company’s core values, policies, and applicable regulations.
- Act as 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.
- Leverage Lean Six Sigma methodologies to create, implement, measure, and report on key performance indicators (KPIs) for manufacturing performance.
Requirements
- B.S. Degree in Engineering/Sciences is required; Advanced M.S./PhD degree in Engineering is a plus.
- Minimum of 8 years of experience working in a cGMP/cGCP environment, preferably in biologics or cell & gene therapy within the biopharmaceutical industry.
- Preferred experience should be a combination of work 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.
- Experience with both bulk drug substance and aseptic drug product is a plus.
- Ability to inspire change and build new processes within a diverse and matrix organizational environment.
- Advanced manufacturing and technical acumen with ability to influence and direct stakeholder decision-making at senior levels.
- Excellent verbal and written communication skills.
- Strong organizational and customer service-oriented skills.
- Ability to work independently and as part of a team.
- Proficient computer skills.
Benefits
- 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.
Pay
The most likely base pay range for this position is $116,000-$162,750 per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation. Total compensation could include bonuses, sales incentives, and equity awards.