Halozyme Jobs (1)

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Principal Engineer, Manufacturing Improvements- this is a remote position.

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 Principal Engineer, M anufacturing Improvements 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 Principal Engineer, Manufacturing Improvements plays a meaningful role in implementing, executing, and streamlining Make, Test and Release systems to facilitate on time and in full delivery of our products throughout the Halozyme external manufacturing supply network.

They provide technical leadership within a team of support staff focused on reliable, efficient and high-quality supply of our Enhanze technology at all commercial contract development & manufacturing organizations (CDMOs).

The Manufacturing Improvements team is the primary liaison between Halozyme support functions and their counterparts at the sites of manufacture.

This role streamlines systems and metrics related to the technical, Quality Assurance, Quality Control, Supply Chain and Manufacturing Functions at Halozyme and our External Manufacturing Suppliers.

The role supports cross site consistency in measurements and defined processes to ensure and delivery.

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

• Act as a senior systems leader within the team of remote staff dedicated to full-time, on-site support at each drug substance site of manufacture in driving consistency of output and delivery across sites and scales.
• Collaborate with Quality Assurance, Quality Control, MSAT, Manufacturing, Supply Chain, Operations Strategy and the External Manufacturing Site Leads to align all functional metrics, Quality plans, manufacturing supply plans and financial tracking across or DS supply network and ensure the metrics are accurately monitored, reported, and supporting systems are maintained across functions to enable success.
• Assist in building and maintaining scalable and sustainable systems across sites supporting the best interest of Halozyme functional teams for reliable and efficient execution and on time product release.
• Work multi-functionally within each entity to support the on-site remote staff who are supporting all critical steps requiring monitoring, troubleshooting or partnered oversight and support on site as necessary in times of planned absence.
• Act as the secondary point of contact for manufacturing related issue escalation within the functions listed above and assist the Manufacturing Improvements Lead in overcoming roadblocks in alignment to schedule.
• Monitor and support as necessary, day to day batch specific technical support (process monitoring, event triage, batch review prioritization) objectives, analytical testing plans and supply chain inventory controls .
• Work collaboratively with CDMOs to implement and / or improve policies, procedures, and establish the necessary service level agreements to ensure reliability of Quality business systems, technical objectives and documented process flows in drug substance manufacturing, testing and release.

To succeed in this role, you’ll need :

• Bachelor’s Degree in relevant scientific or engineering field with a minimum of 10 years of experience in Operations, Quality Assurance, manufacturing sciences and Technology (MSAT) or related field within the biopharma industry (an equivalent combination of experience and education may be considered).
• Proven experience supporting external manufacturing oversight and manufacturing and quality systems in GMP environments.
• Strong expertise in drug substance operations, testing, supply chain and lot release systems.
• Deep knowledge of GMP’s, global regulatory requirements (FDA, EMA, ICH), and other relevant regulatory guidelines, policies, and guidance documents.
• Proven track record effecting positive and sustainable change with a track record of aggressive problem solving and system development in a collaborative, and supportive learning environment.

In return, we offer you :

• Remote work flexibility
• 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 $124K - $170K annually. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation.