Senior/ Advisor – Peptide Process Development

Job Description:

Responsibilities

• The employee leads technical aspects of drug substance manufacturing including process optimization, technical transfers and development of the technical agenda.
• This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.
• The successful candidate should have a proven track record of driving technical agendas and influence externally in the peptide space.
• Provide technical oversight and stewardship for peptides and manufacturing processes.
• Leads resolution of technical issues including those related to control strategy and manufacturing.
• Proven experience at leading post launch technical agendas and delivering projects that have driven substantial step changes in manufacturing (specific to M&Q and may not be required for development).
• Employ excellent communication skills to manage internal and external relationships.
• Manage project work through active coaching and delegation of junior scientists and engineers.
• Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.

Qualification & Experience

• PhD in scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, or related fields, or equivalent industry experience.
• PhD + Post Doc in Chemistry (focusing more Peptide chemistry) with 12+ years