Main Purpose and Objectives:
- The TS/MS Associate Director leads/mentors technical staff and oversees chemical synthesis processing related to cGMP API commercial manufacturing.
- Manages routine production support while balancing technical projects and process optimizations; guides direct reports on priorities and time management.
- Supports technical transfer of new processes, develops and executes process and process-related validation plans, establishes process control and capability, and maintains GMP compliance in associated documents and activities.
- Partners with engineering, manufacturing, validation, QA, QC, development, and regulatory to implement the technical agenda.
Responsibilities:
- Maintain a safe work environment and lead safety initiatives (HSE goals).
- Hire, manage, and grow a team supporting technology transfer, process validation, manufacturing operations, and continuous improvement.
- Ensure oversight and technical excellence for investigations and complaints.
- Provide technical review/approval of quality documents, plans, regulatory submissions, and validation-related studies.
- Interact with regulators/customers/stakeholders and support internal/external audits.
- Provide strategic direction to improve process capability, control, yield, and productivity across the site portfolio.
- Network globally to share best practices and harmonize control strategies.
Basic Requirements:
- BS or MS in Chemistry, Microbiology, Biochemistry, Biochemical engineering, or related science.
- 5+ years of cGMP commercial API manufacturing experience in Technical Services or related disciplines.
Additional Preferences:
- Experience in small molecule, peptide, or oligonucleotide manufacturing.
- Technical leadership; organizational/administrative skills.
- Strong project management; analytical/quantitative problem-solving.
- Ability to communicate/influence across stakeholders; strategic thinking.
Other Information:
- Occasional travel (5β10%).
- Onsite work required; on-call; shift work may apply.