Job Title: Principal Scientist - Cell and Gene Therapy, Biologics, Chromatography, TFF
Location: Indiana, United States
Job Type: Full-Time
Job Summary:
We are seeking a highly skilled and experienced Principal Scientist to lead scientific initiatives in the development and optimization of processes related to Cell and Gene Therapy, Biologics, and separation technologies like Chromatography and Tangential Flow Filtration (TFF). The successful candidate will drive innovation, lead cross-functional teams, and provide scientific expertise for advancing bioprocesses from research to clinical and commercial stages.
Key Responsibilities:
- Lead Process Development: Direct the design, optimization, and scale-up of bioprocesses, including upstream and downstream activities for Cell and Gene Therapy, Biologics, and other therapeutic modalities.
- Innovative Research: Drive scientific research in cell and gene therapies, ensuring cutting-edge approaches to biologics manufacturing and purification.
- Chromatography & TFF Expertise: Serve as the subject matter expert in Chromatography (e.g., affinity, ion exchange, size-exclusion) and TFF techniques, applying these methods to the purification and concentration of biological products.
- Cross-functional Collaboration: Collaborate with R&D, clinical, regulatory, and manufacturing teams to ensure seamless process development and alignment with regulatory standards.
- Mentorship & Leadership: Mentor junior scientists, guiding the scientific team through problem-solving, experimental design, and data analysis.
- Technology Transfer: Oversee the transfer of processes from the laboratory to clinical and commercial manufacturing, ensuring scalability and compliance with cGMP standards.
- Regulatory Compliance: Ensure adherence to regulatory guidelines, prepare technical documents and reports for regulatory submissions (e.g., INDs, BLAs).
- Project Management: Manage multiple projects concurrently, ensuring timely completion of milestones, budgeting, and resource allocation.
- Continuous Improvement: Stay current with industry trends, emerging technologies, and scientific advancements in biologics and cell and gene therapy. Propose and implement continuous improvement initiatives to enhance process efficiency and quality.
Required Qualifications:
- Degree in Biochemistry, Molecular Biology, Biotechnology, or a related field, with a minimum of 8+ years of experience in biopharmaceutical process development, specifically in Cell and Gene Therapy or Biologics.
- In-depth expertise in Chromatography (affinity, ion exchange, SEC) and TFF techniques used in biologics purification.
- Proven experience in leading cross-functional teams, managing projects, and mentoring scientists.
- Hands-on experience with cGMP manufacturing and technology transfer for clinical and commercial-scale processes.
- Strong understanding of regulatory requirements (FDA, EMA, ICH) related to biologics and gene therapy.
- Excellent problem-solving skills, attention to detail, and the ability to work in a fast-paced, dynamic environment.
Preferred Qualifications:
- Experience with viral vector or plasmid production.
- Expertise in analytics related to biologics characterization (e.g., HPLC, mass spectrometry, ELISA).
- Familiarity with automation and data analytics tools used in bioprocess development.
- Experience in authoring regulatory submissions (e.g., IND, BLA, MAA).
