Senior Manager, Drug Product Development

Arcutis Biotherapeutics

About The Position

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.

Requirements

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
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

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