Senior Scientist, Small Molecule API Process Development Job Description Template
Our company is looking for a Senior Scientist, Small Molecule API Process Development to join our team.
Responsibilities:
- Support Translational Research and Business Development as a technical consultant;
- Follow all safety and compliance regulations and company policies at work;
- Support Manufacturing Management and Quality in deviation investigations and product life cycle management;
- Lead selection and evaluation of CROs and CMOs and manage their activities to ensure timely delivery of high quality work packages;
- Collaborate with other functional areas in the CMC project team to deliver project milestones on time and within budget;
- Author relevant sections in regulatory filings and address agency questions.
Requirements:
- Must have hands-on experience in API process development, tech transfer, and manufacturing support for small molecules;
- Experience in both early stage and late stage process development is desired;
- Experience working with antisense oligonucleotides process development is preferred;
- Working knowledge of statistical design of experiments (DOE) is desired;
- Requires working knowledge of IND/IMPD/NDA/MAA filing, being familiar with quality and regulatory requirements;
- Must have excellent problem solving skills and verbal and written communication skills;
- Experience working with contract manufacturing organizations is preferred.