Principal Engineer 1, Manufacturing Sciences & Technology
Principal Engineer 1, Manufacturing Sciences & Technology
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Job Description
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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. Thats why we need youto 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 youll be part of a culture that welcomes diversity thinks differently to solve problems works collaboratively as one team and delivers meaningful innovations that impact peoples 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 youll 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 youll need:
Bachelors 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 GMPs 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 impacton 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 individuals 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 .
To view all our open positions please visit our career page. Additionally our benefit offerings can be found here.
Required Experience:
Staff IC
Employment Type
Full-Time
