Production Project Manager

A brief overview

As the Production Project Manager, you will represent Production on cross-functional customer project teams as the subject matter expert (SME). You ensure timely completion of project-related tasks within the operating line and manage sub-teams as needed. You proactively update the project leader and business development/sales on scope changes and collaborate with the customer SME and other cross functional PMs to develop solutions for product-related issues, including deviations, OOX, and scope changes.

What you will do

• Ensure ongoing production, analysis, review is performed within the cycle time (in production) and within the committed service processing time in QC and QA.
• Map processes (material and information flow) down to detail levels that allow the time needed for every task or group of tasks to be measured; develop strategies to reduce cycle and service processing times and keep functional E2E-process mapping up to date following the Plan-to-Produce process.
• Consult and work closely with functional area managers and scheduler to optimize the production schedule daily, ensuring projects remain on track against project timelines; utilize Huddles to communicate and consult with line functions, ensuring SAP OOP dates and every batch are always updated.
• Drive process improvements, including revalidation and change implementation as required to advance the knowledge space of the process.
• Compile campaign reports after every production campaign based on defined KPIs, trends and lessons learned.
• Accountable for BoM and recipe maintenance and responsible for the Master Batch Record maintenance after every campaign.
• In coordination with the line function, develop proposals for CAPEX investments as needed to meet production objectives.
• Prepare for and attend customer interactions (meetings, workshops and visits) to better coordinate key deliverables and ensure customer satisfaction.
• Serve as a crucial link, communicating customer needs and strategies to the production team, serving as the advocate for the product within the team, securing resources and assets for their programs, and ensuring information flow within the department to build and enhance the customer relationship.

Qualifications

• Bachelor's Degree in Science or Engineering (Chemistry, Chemical Engineering, Biochemistry, Biology or similar fields) required
• Master's Degree M.S. preferred
• PhD in Science or Engineering field preferred
• 4-6 years Experience in Biotech/Pharma/CMO industry with good knowledge of CMC development of APIs and KSAs required
• 4-6 years 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 required
• Chemistry, Manufacturing, and Controls (CMC) knowledge associated with IND and NDA filings
• 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, Master Control, Document-sharing (SharePoint, ShareFile), ERP (SAP), online and video-conferencing meetings (i.e., MS Teams)
• Excellent written and oral communication skills
• Works independently and capable of managing one's time
• Familiarity with drug substance characterization analysis (HPLC, UPLC, LC-MS, MS, GC-MS, AAA, CHN)
• Portfolio Management Professional (PMP) preferred