Senior Manager, Drug Substance Development

TheSenior Manager Drug Substance Development is a key member of the Process Technology team responsible for advancing drug substance development activities across programs. To be successful in this role the candidate must be able to work collaboratively in a fast-paced environment navigate ambiguity and drive results. This position reports to the Senior Director Process Technologies and Manufacturing and serves as a strategic partner across cross-functional teams.

Roles & Responsibilities

1. Lead drug substance development activities across preclinical clinical and commercial programs including technology transfer process characterization validation support lifecycle management and support for IND BLA/MAA and commercial launch activities.
2. Serve as a key technical lead for CDMO relationships providing oversight for manufacturing readiness campaign execution issue resolution and performance follow-up.
3. Support compliant and reliable manufacturing operations through review of batch records deviations investigations change controls and risk assessments.
4. Collaborate closely with Quality Regulatory Analytical Drug Product Supply Chain and Project Management teams to align technical strategy timelines and supply plans.
5. Contribute to the preparation authoring and review of technical reports regulatory submissions and responses to health authority questions inspections and audits.
6. Represent the function on CMC and project teams supporting team objectives and key project deliverables.
7. Plan design and execute univariate and multivariate drug substance process characterization and validation studies with external sites including development of small-scale models quality oversight and timely execution.
8. Collaborate effectively with employees contractors and consultants to deliver organizational goals.

Education & Licenses and Experience

Advanced degree in chemical engineering biochemical engineering biochemistry biotechnology pharmaceutical sciences or a related scientific discipline required; MS or PhD preferred with 8 years of drug substance development experience in the biopharmaceutical industry.

Strong experience in drug substance development including process development technology transfer manufacturing support and regulatory CMC contributions for late-stage programs is highly desirable.

Competencies & Skills

• Experience with monoclonal antibody or fusion protein process development is a plus.
• Experience with QbD methodologies and statistical analysis using JMP.
• Strong knowledge of biologics drug substance processes including upstream and downstream operations scale-up process characterization validation support and technical troubleshooting.
• Hands-on experience working with CDMOs and external partners in development and manufacturing settings.
• Excellent communication collaboration and project management skills with strong attention to detail and the ability to work independently and effectively across technical and cross-functional teams.
• Proven ability to manage multiple priorities in a fast-paced environment with flexibility to travel domestically and internationally as needed.
• Travel may be required for up to 25% of time worked.

Why Join Us
Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company and we are looking for top talent to join our team. We are nimble collaborative and passionate about achieving our mission!

This job description has been designed to indicate the general nature and level of work performed by employees in this position. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to the job.

Arcutis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race color sex age national origin religion sexual orientation gender identity status as a veteran and basis of disability or any other federal state or local protected class.

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