Senior Engineer II, MS&T

Elektrofi Inc.; Boston (MA); On-site; USD 116,000 - 162,750; Full time

Benefits offered by this job

Health insurance

401(k) matching

Tuition reimbursement

Job summary

Halozyme Hypercon, Inc. seeks a Senior Engineer II, Manufacturing Science and Technology to execute technology transfer and drive continuous process improvements for its aseptic formulation processes.

You will collaborate across Program Management, Analytical & Process Development, Quality, Supply Chain, Engineering and Manufacturing. Global travel up to 25% may be required; the role emphasizes Lean six sigma, data analysis and cross-functional leadership in a fast-paced environment supporting

Qualifications

• BS in Engineering/Sciences required; MS/PhD in Engineering a plus.
• Advanced manufacturing and technical acumen with ability to influence senior stakeholders.
• Excellent verbal and written communication skills.
• Proficient computer skills and ability to work independently.

Responsibilities

• Execute technology transfer and continuous process improvements for aseptic formulation and filling.
• Lead and own process and manufacturing risk assessments with mitigation plans.
• Review process control schemes, P&IDs, automation modules, batch records.
• Partner with internal and external stakeholders to align production plans with clinical demand.
• Support regulatory site inspections and implement new data-analytic technologies.

Job description

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 decision-making at senior levels is required.
• 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.

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 $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. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.

Equal Employment Opportunity Statement

Halozyme Hypercon, 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 (including traits historically associated with race, including but not limited to: hair texture and protective hair styles), religion, religious creed (including religious dress and grooming practices), ethnicity, color, national origin, ancestry, age (40 and older), genetic information, disability (mental and physical, including HIV and AIDS), reproductive health decision-making, medical leave or other types of protected leave, domestic violence victim status, political affiliation, medical condition (including cancer/ genetic characteristics and information), sex, gender, gender identity, gender expression, sexual orientation, marital or familial status, citizenship, pregnancy (including perceived pregnancy, childbirth, breastfeeding, or related medical conditions), military or veteran status, or any other status protected by federal, state, or local law.

Know Your Rights Poster.

Accessibility and Reasonable Accommodations

Halozyme Hypercon is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or an accommodation due to a disability, contact Human Resources at [e-mail].

Halozyme Privacy Notice

Applicant Privacy Notice.

To all agencies, please, no phone calls or emails to any employee of Halozyme Hypercon about this requisition. All resumes submitted by search firms/employment agencies to any employee at Halozyme Hypercon via email, the internet, or in any form and method will be deemed the sole property of Halozyme Hypercon unless such search firms/employment agencies were engaged by Halozyme Hypercon for this requisition and a valid agreement with Halozyme Hypercon is in place. If a candidate submitted outside of the Halozyme Hypercon agency engagement process is hired, no fee or payment of any kind will be paid.