Description
The Senior Manager, Drug Product Development is a key member of the Manufacturing and Process Technology Team. To be successful in this role, the candidate should be able to work collaboratively in a fast-paced environment, navigate ambiguities, and drive results forward. This position will report to the Senior Director of Process Technologies and Manufacturing, and will serve as a business partner to other parts of organizations.
Roles & Responsibilities
- Lead formulation, Device, and Drug Product deliverables to support pre-clinical, clinical/pivotal studies leading to IND, BLA/MAA and commercial launch
- Evaluate molecules for CQAs by the means of accelerated conditions and stress exposures, characterizing molecule variants and degradants
- Plan, design and execute univariate/multivariate formulation and DP process characterization/validation studies with external testing sites, and drive timely execution with quality oversight
- Guide CRO in analytical testing with chromatographic and biophysical methods (e.g. SEC-MALS, DLS, spectroscopy etc.) to support product and process characterization
- Devise the DP and Device process technology transfer, qualification, and validation strategy, for clinical/commercial product site transfer
- Provide on-going fill-finish manufacturing support to Drug Product sites/CMOs: including technology transfers and impact assessments, during quality investigations to ensure product and process consistency
- Partner with internal/external manufacturing and quality for process improvement, transfers, compilation and review of batch records, master production records and technical support to resolve investigations, deviations, corrective/preventative actions
- Author and review technical protocols and reports, to document study findings in support of Investigational New Drug (IND), IND amendments, BLA/MAA and other global regulatory filings
- Participate in CMC/project teams for functional representation as well as support teams' objectives and project deliverables
- Evaluate biochemical and biophysical methods suitable for MaB and fusion protein molecular assessment and product characterization
- Collaborate with full-time employees, contractors, and consultants, to deliver organizational goals
Education & Licenses and Experience
Ph.D. in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and 5+years of product development experience in industry or BS/MS with 10+ years of experience
Experience with biologics formulation development, Drug Product process design, Device development, and manufacturing Fill/Finish, is highly desirable
Competencies & Skills
- Experience with MaB or fusion protein process/formulation/analytical development is a plus
- Sound understanding of analytical methods for formulation characterization (e.g. qPCR/ddPCR, UV-vis, H/UPLC, capillary electrophoresis and biophysical techniques (e.g. SEC-MALS, DLS, AUC, Fluorescence, particle analysis, etc.)
- Experience in QbD methodologies and statistical analysis using JMP
- Good knowledge of FDA guidance as well as cGMP and ICH requirements
- Experience or contribution to regulatory submissions, through any phase of product development
- Excellent communication (oral and written) and attention to detail, ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- 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 exciting 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!
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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Equal Opportunity Employer, including disability/protected veterans
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