Responsibilities:
- Participate in and/or lead project teams for drug substance process development and characterization.
- Develop and characterize laboratory drug substance processes and translate them to scalable processes.
- Proactively advise and share expert knowledge with subordinates, peers, and senior management; mentor staff to troubleshoot strategic/experimental issues.
- Author and review key regulatory documents, laboratory data, technical memos, and reports.
- Lead project strategies; define responsibilities and timelines; develop control strategies.
- Provide leadership in a matrixed team setting; develop robust processes for cGMP manufacturing.
- Collaborate cross-functionally with organic/analytical chemists, engineers, drug product development, and program management.
- Identify and nurture continuous improvement ideas within the department.
Qualifications:
- BS (16+ years); MS (14+ years) or PhD (8+ years) in Chemistry or allied field, plus 8+ years pharmaceutical laboratory experience.
- Proven scientific leadership; strong interpersonal and communication skills; ability to lead cross-functional process development teams.
- Experience with GMP drug substance manufacturing and process development.
- Experience managing and developing scientific leaders.
- Strong understanding of modern organic chemistry, mechanistic theory, process development, control strategy development, and regulatory starting material strategies.
Benefits (if eligible): paid time off, medical/dental/vision insurance, and 401(k).