Senior Principal Scientist

🔥 5 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $179k - $212k / year

⏰ Full Time

🟠 Senior

🧬 Research Scientist

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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CSL

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1916

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $111M Post-IPO Equity on 2004-02

Healthcare • Biotechnology • Pharmaceuticals

CSL is a global leader in biotherapeutics and vaccines, focused on the needs of patients with serious and rare diseases. The company comprises CSL Behring, which develops and delivers treatments for conditions like immunodeficiency, hereditary bleeding disorders, and Alpha 1 Antitrypsin Deficiency; CSL Seqirus, a major provider of influenza vaccines; and CSL Vifor, which specializes in iron deficiency and nephrology. CSL operates an extensive R&D network focused on plasma fractionation, recombinant protein technology, cell and gene therapy, and vaccines. Headquartered in Melbourne, Australia, CSL serves patients in over 100 countries with a commitment to innovation and sustainable practices in biotechnology.

📋 Description

• Serve as a senior scientific subject matter expert for Chemistry, Manufacturing and Controls activities supporting innovative biologics • Provide expert technical assessment, scientific guidance, and risk-based recommendations to program teams • Apply scientific and technical expertise to CMC strategy discussions, including process development, analytical development, characterization, manufacturing, technology transfer, stability, control strategy, and lifecycle management • Develop data-driven technical recommendations and fit-for-purpose approaches for programs • Serve as a subject matter expert for cell and gene therapy and cell-based therapeutic platforms • Provide technical input and scientific oversight for external development and manufacturing partners • Support technical scope definition, deliverable review, issue investigation, and risk mitigation • Participate as a senior CMC expert on cross-functional program teams • Partner with Process Development, Analytical Development, Quality, Regulatory CMC, Manufacturing, Supply Chain, Engineering, Clinical Development, and other functions • Share platform knowledge, advance scientific standards and technical practices, evaluate external innovation, mentor colleagues, and promote continuous improvement

🎯 Requirements

• Advanced degree in a relevant scientific or engineering discipline preferred; Bachelor’s degree with significant relevant industry experience will be considered • 8+ years of relevant industry experience in CMC, process engineering, pharmaceutical development, biotechnology, chemical manufacturing, process development, manufacturing, or a related technical discipline • 5+ years of experience in the cell and gene therapy field preferred • Direct experience with cell and gene therapy and/or cell-based therapeutic platforms • Familiarity with AAV or other viral vector development and manufacturing is a plus • Demonstrated experience in process improvement development and execution • Ability to identify technical gaps, recommend improvements, and support implementation • Demonstrated experience organizing, developing, and deploying best-practice frameworks, processes, tools, and templates • 5+ years of experience working within a global matrix organization • Experience with cross-functional, multicultural, and international teams • Familiarity with baculovirus-based expression systems, insect cell platforms, oligonucleotides, nucleic acid-based therapeutics, recombinant proteins, or other emerging modalities is a plus • Demonstrated experience working with external development and manufacturing organizations, including CDMO selection, technical due diligence, technology transfer, governance, and issue resolution • Strong understanding of CMC principles across product and process development, analytical strategy, control strategy, manufacturing, technology transfer, stability, regulatory requirements, and lifecycle management • Demonstrated ability to influence technical direction through subject matter expertise, evidence-based recommendations, and effective collaboration in a global, matrixed pharmaceutical or biotechnology environment

🏖️ Benefits

• Incentive compensation • Equity • Inclusion and Belonging culture • Reasonable accommodation for applicants with disabilities

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