Senior Director, CMC Technical Lead

Job Description

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 a Senior Director, CMC Technical Lead , 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 an experienced CMC Technical Lead to join our Program Management and Portfolio Strategy team. This is a technical role that will lead cross-functional program teams – from early development through launch. This role will serve as the primary technical and strategic interface between internal cross-functional teams, external partners, and regulatory authorities to ensure successful development of biologics on the Hypercon™ Platform. The role requires dynamic leadership expertise in biologics nonclinical development and CMC and strong decision-making abilities. 

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

• Drive the development and implementation of the integrated scientific, technical, and regulatory strategy of programs in the portfolio ensuring alignment with overall program objectives and regulatory requirements.
• Partner with the program manager, functional heads, and technical SMEs to integrate nonclinical, formulation, process and analytical development, manufacturing and regulatory plans.
• Partner with the program manager, functional heads, and technical SMEs to identify risks, and implement mitigation strategies for each program.
• Support regulatory strategy development and health authority interactions as the lead contributor
• Act as the primary technical interface between the company and Alliance Partners, ensuring transparent communication and alignment.
• Facilitate effective decision-making by preparing clear program updates, risk assessments, and recommendations for governance and senior leadership.
• Facilitate technical governance meetings, decision-making forums, and stage-gate readiness reviews.
• Serve as the primary interface between the Program team and Company leadership, ensuring that the program’s technical strategy and operational plans are aligned with Elektrofi’s short- and long-term goals.
• Foster a collaborative, high-performing team environment that encourages accountability and solution-oriented thinking.

Requirements:

  To succeed in this role, you’ll need:

• Advanced degree (BS considered with strong experience) in scientific or engineering discipline.
• 12+ years of biotech/pharma industry experience, including 5+ years of CMC program leadership in biologics development.
• Proven ability to lead complex, cross-functional teams in a matrix environment.
• Ability to operate strategically while also managing tactical execution details.
• Strong team player who can rapidly build positive relationships, proactively partner across teams with the ability to motivate and influence others and negotiate diplomatically.
• Deep understanding of end-to-end drug product development, manufacturing, and regulatory expectations for biologics. Experience working with high-concentration and subcutaneous formulations is preferred.
• Strong understanding of biologics CMC development, from preclinical through clinical stages with regulatory submission experience (IND/CTA, BLA/MAA). 
• Excellent oral and written communication skills, and attention to detail to ensure high quality presentations and regulatory submissions.

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 $235,000-$285,000 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.

Click here to view the 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 View email address on us.fitly.work.

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.

 
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