Job Type
Full-time
Description
How you will make an impact Halozyme Hypercon is seeking an experiencedCMC 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.
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Salary Description
$235,000 - $285,000
