Brief Job description:

The QC Associate Director of Technology will be primarily focused on helping to optimize delivery of new technology to the Wuxi QC laboratory and Operations using process analytical technologies (PAT) to facilitate real-time release.

They will be responsible for analytical technology transfer, model maintenance and procedure, model updates for PAT applications, super user of PAT data management systems, supporting the transformation of AZ commercial manufacturing through continuous direct compression (CDC) for oral solid dosage forms (OSDs).

The role will partner with PET’s, Quality, Second-Line Technical Support (TOSI), Research and Development (PT&D), Sister-Sites, and IT to identify and implement new digital and PAT opportunities to continually drive improvements for Wuxi Operations.

This position will also aid the introduction of new manufacturing technologies by ensuring all QC related activities are represented.

The role may also have overarching ownership of systems and processes throughout portions of the lab.

Accountabilities:

As an Associate director, you will:

Provide expert support to continuous manufacturing of commercial products, provides analytical expert knowledge and support to the complex troubleshooting issues, and oversees the delivery of training and coaching.

Your knowledge in PAT, analytical science and technologies will be crucial in ensuring efficient and effective delivery on analytical technology transfer, modelling maintenance, control strategy and testing for commercial manufacturing and supply for CDC products, and GMP inspections.

Play a proactive role in seeing opportunities for PAT method improvements for process robustness, and major change management/project management.

Oversee the analytical technology transfer and related method validation, CMC dossier support and ensure compliance with pharmacopeia/regulatory requirements.

Essential Skills/Experience:

• Ph.D. – 3+ years, MS – 5+ years, BS – 8+ years of relevant industry experience. Degree in relevant field (Analytical Chemistry, Pharmaceutical Sciences, or Engineering etc.)
• Scientific leadership skills
• Proven track record to think and operate across functional boundaries
• Effective influencing and prioritization skills
• Good communication and stakeholder management skills
• A strong understanding of key process analytical technologies, especially NIR, Raman, microwave resonance spectroscopy.
• Demonstrated expertise in PAT method development, implementation, optimization and use of Multi-variate data analysis/ Chemometrics (MVDA, PCA, PLS)
• Knowledge of the principles and management of Safety, Health & Environment (SHE)
• Business acumen and capability to understand business cases in subject matter areas.

Desired Skills/Experience:

• Work experience in the industry in a PAT /chemometrics based role
• An understanding of other key analytical techniques such as separation science, NMR and mass spectrometry
• Previous experience and training in Lean, problem-solving tools and experience in data analysis and interpretation
• Functional mastery of written and spoken English
• Good communication and strong ownership
• Competent in problem solving and risk analysis

Key Relationships:

Internally: Related functions and departments at Wuxi site, TOSI, Research and Development (PT&D), other operation Sites, IT, Regulatory, etc.

Externally: external vendor, IDCs