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Your Role: Senior Research Scientist , Synthetic Molecule API Development
As a Sr. Research Scientist in Synthetic Molecule API Development , you will play a vital role in our global team, driving new chemical entities (NCEs) towards commercialization. You will leverage your expertise in API route development and regulatory requirements to lead projects with CDMO partners . You will deliver innovative technical solutions and cultivate strong strategic relationships to bring products to the global market.
You will report to the Senior Director of Global API Development, based in Indianapolis, USA .
Your Responsibilities:
- Lead the development of robust, safe, and cost-efficient commercial routes for synthetic molecules (including peptides) . Drive technical solutions by resolving chemical process challenges at CDMO partners during the scale-up, tech transfer, and registration campaigns. Secure intellectual property by identifying patentable innovations and supporting patent filings .
- Support evaluation and selection of CDMOs for API development and manufacturing with a focus of partners in ASIA/Pacific. Provide technical oversight of CDMO partners, managing work packages and budget forecasting to ensure the delivery of project milestones in cooperation with alliance management and procurement functions.
- Conduct CDMO on-site visits to verify quality standards, process safety, and timelines while cultivating productive and long-term business collaborations.
- Collaborate closely with internal analytical development, formulation development, and other cross-functional partners to ensure the timely delivery of API quantities for development programs. Act as a point of contact to manage projects and work packages and communicate status to the global project teams .
- Prepare and review registration-relevant documentation to support global regulatory submissions and market authorizations. Ensure all API development activities comply with regulatory requirements and cGMP standards .
- Provide expert API opinions and technical guidance to support business development and licensing initiatives, including due diligence support.
What You Need to Succeed (minimum qualifications):
- Education : PhD in organic chemistry or chemical engineering , or related scientific fields (5+ years industry experience); or an M.S. degree (10+ years industry experience).
- Technical Expertise: Strong expertise in r oute selection, process development/optimization, and process tech transfer .
- Experience : Proven experience working with CDMOs and a solid understanding of cGMP production that meets regulatory requirements.
- Language : Fluent in English and Chinese (spoken and written) to facilitate communication between global teams and local partners.
What Will Give You a Competitive Edge (preferred qualifications):
- Advanced education or working experience in Chemical Engineering .
- Education in peptide synthesis or experience working with s ynthetic peptide drug development .
- Expertise in solid state property characterization and data interpretation.
- Experience with statistical tools and principles (e.g. design of experiments )
Additional Information:
- Location: China – Shanghai office
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
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