Position Summary: A cutting-edge Biotech is looking to expand their Analytical team by bringing on a Principal Scientist.
Key Responsibilities:
- Lead and oversee analytical development projects for biologics and CGT, from early to late-stage development.
- Design and implement robust analytical strategies to support product development and regulatory submissions.
- Develop and validate analytical methods for the characterization and quality control of biologics and CGT products.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure seamless project progression.
- Mentor and manage a team of scientists, fostering a collaborative and innovative work environment.
- Stay current with industry trends and advancements in analytical technologies and methodologies.
- Prepare and review technical reports, regulatory documents, and scientific publications.
Qualifications:
- Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or a related field.
- Minimum of 4 years of industry experience in analytical development for biologics and CGT.
- Proven experience in early and late-stage development projects.
- Strong leadership and internal management skills, with a track record of mentoring and developing scientific talent.
- Expertise in analytical techniques such as HPLC, mass spectrometry, ELISA, and cell-based assays.
- Excellent problem-solving skills and the ability to work effectively in a fast-paced, dynamic environment.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.