Principal Scientist to Associate Director, Analytical Development

About the role

Structuretx is seeking a highly skilled and motivated individual to fill the position of Principal Scientist to Associate Director in our Analytical Development team. This role is in advancing our analytical capabilities and ensuring the successful development of our innovative biotherapeutics. The ideal candidate will bring a wealth of experience in analytical methodologies and a strong leadership presence to guide our team in delivering high-quality results. You will play a crucial role in shaping the future of our analytical strategies while collaborating closely with cross-functional teams to drive project success.

Key facts

What you'll do

• Lead the analytical development efforts for biopharmaceutical products, ensuring compliance with regulatory standards and industry best practices.
• Design and implement analytical methods for the characterization and quantification of drug substances and drug products.
• Oversee the development and validation of analytical techniques, including but not limited to HPLC, mass spectrometry, and other relevant methodologies.
• Collaborate with formulation scientists to support the development of drug formulations and stability studies.
• Provide technical guidance and mentorship to junior scientists and team members, fostering a culture of innovation and continuous improvement.
• Prepare and review documentation for regulatory submissions, ensuring that all analytical data is accurate and well-presented.
• Engage in cross-functional project teams, contributing analytical insights to support product development timelines and objectives.
• Stay abreast of industry trends and advancements in analytical technologies, integrating new approaches into the team's workflow as appropriate.
• Manage project timelines and resources effectively, ensuring that analytical milestones are met in alignment with project goals.
• Participate in the recruitment and training of new team members, helping to build a high-performing analytical development team.
• Represent the company at scientific conferences and meetings, sharing findings and promoting Structuretx's capabilities in analytical development.
• Collaborate with external partners and vendors to enhance analytical capabilities and support project needs.

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, or a related field with a minimum of 8 years of relevant experience in the biopharmaceutical industry.
• Proven track record of developing and validating analytical methods for biologics, with a deep understanding of regulatory requirements.
• Strong leadership skills with experience managing teams and projects in a fast-paced environment.
• Excellent problem-solving abilities and a proactive approach to overcoming challenges in analytical development.
• Proficient in using various analytical instrumentation and software, including HPLC, UPLC, and mass spectrometry.
• Strong communication skills, both verbal and written, with the ability to present complex data clearly to diverse audiences.
• Experience in preparing regulatory submissions and interacting with health authorities is highly desirable.

Nice to have

• Familiarity with quality by design (QbD) principles and their application in analytical development.
• Experience in the development of biosimilars or complex biologics.
• Knowledge of statistical analysis tools and methodologies for data interpretation.

Skills & tools

• Proficiency in analytical techniques such as HPLC, LC-MS, and other relevant methodologies.
• Strong understanding of biopharmaceutical development processes and regulatory frameworks.
• Experience with data analysis software and tools for method validation and statistical analysis.
• Familiarity with laboratory information management systems (LIMS) and electronic laboratory notebooks (ELN).

Practical notes

• This position is based in Shanghai, within the Pudong District, known for its dynamic business environment and innovative culture.
• The successful candidate will be expected to work collaboratively in a team-oriented atmosphere while also demonstrating the ability to work independently when required.
• Structuretx offers a competitive salary and benefits package, along with opportunities for professional development and career advancement.
• Candidates requiring visa sponsorship should indicate this in their application, as we are open to considering qualified international applicants.

If you are about advancing analytical development in the biopharmaceutical sector and are looking for a challenging and rewarding opportunity, we encourage you to apply for the Principal Scientist to Associate Director position at Structuretx. Join us in our mission to develop innovative therapies that make a difference in patients' lives.

About the company

Medicine is our platform. Accessibility is our cure.