Job Description

Job Summary

We are seeking a highly experienced and motivated individual to join our team as the Director of Biologics- Materials and Biophysical Characterization. The successful candidate will lead our biophysical characterization group in biologics, overseeing the analysis and interpretation of the physical and chemical properties of biopharmaceuticals. This role is critical to ensuring the quality, efficacy, and safety of our products through advanced biophysical techniques and methodologies.

Key Responsibilities

• Lead and manage the biophysical characterization team, providing scientific and technical guidance, mentorship, and support.

• Develop and implement strategic plans for biophysical characterization to support the research and development of biopharmaceuticals.

• Oversee the design, execution, and interpretation of experiments utilizing a range of biophysical techniques, including but not limited to spectroscopy, calorimetry, light scattering, advanced microscopy and chromatography.

• Collaborate with cross-functional teams, including research, development, quality control, and regulatory affairs, to ensure comprehensive biophysical characterization of products.

• Ensure compliance with regulatory guidelines and industry standards related to biophysical characterization.

• Drive innovation and continuous improvement in biophysical characterization techniques and methodologies.

• Prepare and review technical reports, presentations, and documentation for internal and external stakeholders.

• Stay current with advancements in the field of biophysical characterization and integrate new technologies and approaches into the team’s work.

• Represent the company in scientific conferences, meetings, and collaborations with external partners.

Education: Ph.D. in Biophysics, Biochemistry, Molecular Biology, or a related field with 8+ years of relevant experience or M.S. in Biophysics, Biochemistry, Molecular Biology, or a related field with 10+ years of relevant experience

Qualifications

• Minimum of 10 years of experience in biophysical characterization, with at least 5 years in a leadership or management role.

• Extensive knowledge and hands-on experience with biophysical characterization, such as particle sizing techniques across a wide range and structural analysis and interpretation using spectroscopy, microscopy, thermal and rheological methods.

• Strong understanding of the principles and applications of biophysical characterization in the context of biopharmaceutical development.

• Proven track record of developing and implementing innovative biophysical characterization strategies.

• Excellent leadership and team management skills, with the ability to inspire and motivate a diverse team of scientists.

• Strong analytical and problem-solving skills, with attention to detail and a commitment to scientific rigor.

• Exceptional communication and interpersonal skills, with the ability to effectively present complex scientific information to a range of audiences.

• Experience with regulatory submissions and compliance related to biophysical characterization.

• Demonstrated ability to work collaboratively in a fast-paced, dynamic environment.

#AR&D

Required Skills:

Accountability, Accountability, Adaptability, Analytical Method Development, Biologics License Application (BLA), Biopharmaceuticals, Chromatographic Techniques, Collaborative Research, Communication, Decision Making, Dosage Forms, Experimental Methods, Mentorship, Microscopies, Molecular Biology, Molecular Microbiology, Multidisciplinary Collaboration, People Leadership, Pharmaceutical Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Submissions {+ 5 more}

Preferred Skills:

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