Principal Engineer 1, Manufacturing Sciences & Technology

Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site.

In order to move forward, you will need to create an account. Your password must be eight characters long, contain at least one special character, one capital letter and a number.

We look forward to discovering your talents.

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 Principal Engineer 1, Manufacturing Sciences & 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 Principal Engineer 1, Manufacturing Sciences & Technology (MSAT) leads operational objectives related to external manufacturing oversight of new and existing downstream manufacturing processes at Halozyme. The role interacts with external contract development and manufacturing organizations (CDMOs), and provides support for planning, execution, and oversight of commercial manufacturing activities at all external manufacturing sites.

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

• Support MSAT team members and provide leadership in the identification of robust and consistent controls for Drug Substance processes, focusing on downstream operations.

• Act as the principal subject matter authority for CMC topics related to downstream drug substance manufacturing: assist in authoring relevant sections of regulatory submissions and requests for information (RFI) responses; establish, rationalize, and defend manufacturing processes and operations for inspection related activities

• Design, draft, and/or review study plans, protocols, reports, and batch process records to support external manufacturing and CMC strategies and present proposals to CMC team on manufacturing strategy and execution in accordance with Halozyme standard policies and procedures as well as current Regulatory guidelines

• Develop, standardize, and improve policies, procedures and systems related to GMP Operations and Manufacturing Sciences and Technology (MSAT) in support of product commercialization and lifecycle management

• Help establish an effective paradigm for leading and improving external manufacturing relationships, activities and process lifecycle at external CDMOs while maintaining full compliance with FDA/EMEA and all major regulatory guidelines

• High proficiency in process monitoring, data analysis, and ability to process and summarize complex data into clear and timely communication

• Perform technical assessment of deviations, non-conformances and change controls and the impact on validated manufacturing processes in a sophisticated and diverse manufacturing landscape

• Collaborate with other functional groups to author, revise, review regulatory submissions; develop and implement plans for manufacturing changes that require health authority approval

• Assist in department budgeting, vendor selection, scope of work establishment and review, and end-to-end project oversight

• Attend seminars/conferences as the need arises to maintain extensive and comprehensive knowledge of innovative principles and techniques relating to production, purification, and testing of bio-therapeutic proteins

To succeed in this role, you'll need:

• Bachelor's Degree in relevant scientific or engineering field with a minimum of 12 years of experience in manufacturing, process development, manufacturing sciences & technology (MSAT) or related field within the biopharma industry (an equivalent combination of experience and education may be considered)

• Extensive experience supporting technology transfer, process validation, and commercial manufacturing operations of recombinant proteins in GMP environments

• Knowledge of regulatory requirements for recombinant protein pharmaceutical products

• Experience in Phase 3 and commercial launch stages of Biologics registrations

• Experience maintaining a positive working relationship with contract manufacturing partners

• Extensive knowledge of GMP's, global regulatory guidelines (FDA, EMA, ICH), and other relevant regulatory guidelines and policies

In return, we offer you:

• 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.

The most likely base pay range for this position is $143K - $200K 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.

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.

Accessibility and Reasonable Accommodations:

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.

To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here.