Associate Director, Technical Operations Drug Substance

Responsibilities

• Reporting to the Director, Technical Operations, the incumbent will assist in strategy development and will independently manage project assignments.
• Effectively manage a team of engineers and scientists supporting drug substance technical transfer by developing a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members.
• Provide end-to-end technical support to assigned areas of focus throughout the project lifecycle including but not limited to quality risk management, strategy development, development of standard operating procedures and master batch records, process development, and process performance qualification.
• Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.
• Review and approve project documents as necessary including drug substance and process support and media technical documents, documents pertaining to utilities, manufacturing equipment and other processes, change controls, batch records, standard operating procedures, corrective and preventative actions among others.
• Act as a subject matter expert in support of quality risk assessments and regulatory inspections.
• Supports team safety, environmental, and compliance objectives.
• Escalates and consults on an as-needed basis with next level manager on more complex decisions impacting critical project milestones.

Qualifications

• Required: Bachelor's, Master’s, or Doctorate degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or related life science or engineering discipline.
• Minimum of four (4) years (Doctorate), six (6) years (Master's), or seven (7) years (Bachelor’s) experience in pharmaceutical operations, technical services, and/or quality operations including prior people management experience.
• Effective decision-making, problem-solving, and communication skills.
• Ability to manage multiple priorities and complex problems in a fast-paced environment.
• Aseptic manufacturing and GMP manufacturing experience, preferably with biological drug substance.

Preferred

• Capital project experience.
• Experience using Lean/Six Sigma tools.