Commercial Manufacturing Team Member - Quality Assurance

Commercial Manufacturing Team Member - Quality Assurance

The Commercial Manufacturing Team (CMT) Member is part of a team composed of representatives from Manufacturing, Quality Assurance, and Quality Control. The CMT Member operates within a matrix reporting structure: team members keep their functional reporting lines but are jointly accountable to the CMT Leader for project execution and deliverables. The CMT Member may be tasked with one or multiple products, depending on the product complexity.

As new products (NCEs) transition from development to the commercial phase, the CMT Member serves as caretaker and process innovation driver to maximize output for peak performance. The CMT Member assists in driving operational excellence and process innovation across QA along with Manufacturing and QC. The remit of the CMT Member is to deliver the value proposition potential of the product(s) by ensuring all aspects of manufacturing and release processes are conducted to ensure Right First Time and full delivery of the product(s) to downstream nodes.

Assist the CMT Leader to ensure ongoing planning, production, analysis, and review is performed within the cycle time (in production) and within the committed service processing time in Quality Assurance.

Learn material and information flows within the commercial setting to ensure robust and efficient product cycles. Maintain and update E2E-process mapping to ensure adherence to our Plan-to-Produce process while reducing cycle and service processing times.

Coordinate with the Team Leader and schedulers to optimize the production schedule for the product(s), ensuring product demand remains on track against planned deliveries and commitment dates. Participate in huddles to optimize equipment usage to improve OEE, ensuring that SAP OOP dates and invoicing dates of all batches are always updated and clearly communicated to all stakeholders, including customers.

Monitor key process data to keep manufacturing in a controlled state. Drive process improvements, including revalidation and change implementation as required to advance the knowledge space of the process.

Work within the cross‑functional CMT team to communicate all deviations and delays to relevant supervisors and stakeholders, and assist in cross‑functional investigations resulting from said deviations to ensure resolution and closure within a timely manner so as to maintain operational continuity and adherence to confirmed delivery dates. Understand daily priorities via huddle board meetings.

Prepare for and attend customer interactions (meetings, workshops, and visits) to better coordinate key deliverables and ensure customer satisfaction. Support preparation for all business reviews.

Maintain a production dashboard that is communicated weekly, bi‑weekly, or monthly, reflecting key performance indicators pertaining to the product(s) manufacturing performance.

In coordination with line functions, the CMT group may develop proposals for CAPEX investments as needed to meet production objectives. Work with the CMT Leader to develop strategic initiative concepts that may improve operations long term.

• Bachelor's Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
• Master's Degree in related field (Preferred).
• PhD in related field (Preferred).
• 4‑6 years proven experience in Quality Assurance within pharmaceutical or chemical manufacturing environments.
• 1‑3 years experience in Biotech/Pharma/CMO industry with good knowledge of CMC development of APIs and KSAs.
• Proficiency in LIMS and quality systems.
• Leading or contributing to operational excellence initiatives.
• Green Belt certification in Lean Six Sigma or equivalent (Preferred).
• Experience working in cross‑functional teams and coordinating daily priorities.
• Experience with data analysis software such as Minitab for data trending and KPI reporting.
• Strong understanding of GMP and regulatory compliance & CMO business.
• Familiarity with project planning tools and methodologies.
• Excellent communication and cross‑functional coordination skills.
• Excellent project management skills able to coordinate complex…