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Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) · 1 day ago

Senior Manager, Drug Product Development

United States

Full-time

Remote

Senior Level

$150K/yr - $160K/yr

5+ years exp

Arcutis Biotherapeutics, Inc. is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases. The Senior Manager, Drug Product Development will lead formulation and drug product deliverables, support pre-clinical and clinical studies, and collaborate with internal and external partners to drive product development and regulatory submissions.

BiopharmaBiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

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

Qualification

Biologics formulation developmentDrug Product process designDevice developmentManufacturing Fill/FinishAnalytical methodsQbD methodologiesFDA guidance knowledgeRegulatory submissions experienceCommunicationAttention to detailSelf-motivationAdaptabilityPositive attitude

Required

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

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

Preferred

Experience with MaB or fusion protein process/formulation/analytical development

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

Travel may be required for up to 25% of time worked