Commercial Manufacturing Team Member

Responsibilities

• Assist CMT to ensure ongoing planning, production, analysis and review is performed within the cycle time (in production) and within the committed service processing time in QC and QA.
• 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 the cycle and service processing times.
• Coordinate with Team Leader and schedulers to optimize the production schedule for their product(s), ensuring product demand remains on track against planned deliveries and commitment dates. Participate in the Huddles to optimize equipment usage to improve OEE, ensuring that SAP OOP dates/ invoicing dates of all batches are always updated and clearly communicated to all stakeholders, including customers.
• Monitor key process data to ensure manufacturing remains 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, delays to relevant supervisors and stakeholders, but also assist in cross-functional investigations resulting from said deviations to ensure resolution and closure within a timely manner so as to maintain operations 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 to ensure customer satisfaction. Support preparation for all business reviews.
• Maintain a production dashboard that will be communicated weekly, biweekly or monthly, reflecting key performance indicators pertaining to the product(s) manufacturing performance.
• In coordination with the line functions, the CMT 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 required.
• Master's Degree MSc preferred or
• PhD in Science or Engineering field preferred.
• 4-6 years proven experience in production, quality control, or quality assurance within pharmaceutical or chemical manufacturing environments required.
• 1-3 years’ experience in Biotech/Pharma/CMO industry with good knowledge of CMC development of APIs and KSAs required.
• Leading or contributing to operational excellence initiatives. Green Belt certification in Lean Six Sigma or equivalent is preferred.
• Experience working in cross-functional teams and coordinating daily priorities required.
• Experience with data analysis software such as Minitab, for data trending and KPI reporting.
• Strong understanding of GMP and regulatory compliance & CMO business.
• Proficiency in SAP, LIMS, and quality systems.
• Familiarity with project planning tools and methodologies required.
• Excellent communication and cross-functional coordination skills.
• Excellent project management skills able to coordinate complex activities of multiple programs simultaneously, assist with customer interactions, good presentation and root cause analysis skills, to support investigations, ability to trend statistical data and good understanding of chemistry, and manufacturing. Peptide manufacturing knowledge preferred.
• Chemistry, Manufacturing, and Controls (CMC) knowledge associated with in-line products. Understanding of all key guidelines, ICHQ3C, Q3A, Q3R, Q7A, Q1, 21 CFR 514.8, etc.
• Effective interpersonal and facilitation skills and works well in a team environment.
• Strong organization skills, attention to details, and ability to work in a fast-paced work environment.
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
• Strong problem solving skills and can quickly troubleshoot and implement solutions.
• Excellent computer skills, especially MS Office, MS Project, Minitab, PowerBI, Master Control, Document-sharing (SharePoint, Share…