锦鲤求职岗位描述
Summary:
Senior Scientist/ Principal Scientist with expertise in formulation and process development of biologics, driving the design, optimization, and scale-up of innovative formulations and manufacturing processes for biologics like mAb, BsAb, enzyme, etc., ensuring compliance with regulatory standards, preferably with proposal design and draft experience.
Job Responsibilities:
The detailed responsibilities include but are not limited to the following:
- Lead the formulation development for biologics (e.g., mAb, BsAb, fusion) in liquid, frozen, or lyophilized forms.
- Lead drug product manufacturing process development and tech transfer to manufacturing sites.
- Generate and maintain technical documentation including protocols, reports and regulatory submission materials regarding formulation and process development.
- Troubleshoot formulation and process issues during development and manufacturing.
- Prepare technical proposals and provide detailed experimental procedures, timelines, deliverables, and pricing to support contract signing.
- Liaise with project managers to ensure proposals align with client needs and company capabilities.
- Monitor ongoing contracted projects, track deliverables, and assist in resolving any technical or scope-related issues during contract execution.
Qualification:
Education
- M.S. with 2+ years in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field.
Experience
- Minimum 2-year experience in biological formulation and process development (industry or academia).
- Experience in preparing technical documents and proposals, as well as experimental cost estimation.
- Familiarity with GMP regulatory frameworks and quality standards for drug product manufacturing.
Skills
- Familiar with formulation and process development of biological drug products.
- Strong organizational and project management skills to balance technical development and tender support tasks.
- Fluent in both Mandarin and English. Strong skills in scientific writing and presentation.
- Good communication skills, able to have clear and precise conversations in problem-solving.