Production Project Manager

Bachem • Vista, CA

77d • $103,520 - $142,340

About The Position

As the Production Project Manager, you will represent Production on cross-functional customer project teams as the subject matter expert (SME). As a Production Project Manager, you ensure timely completion of project-related tasks within the operating line and manage sub-teams as needed. You will 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. You share responsibility for the project's success and managing key activities as outlined in the PM guide.

Requirements

• Bachelor's Degree in Science or Engineering (Chemistry, Chemical Engineering, Biochemistry, Biology or similar fields)
• 4-6 years Experience in Biotech/Pharma/CMO industry with good knowledge of CMC development of APIs and KSAs
• 4-6 years Excellent Project management skills able to coordinate complex activities of multiple program simultaneously
• Good presentation and root cause analysis skills, to support investigations
• Ability to trend statistical data and good understanding of chemistry
• 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
• 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., Skype)
• 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)

Nice To Haves

• Master's Degree M.S. (Preferred)
• PhD in Science or Engineering field (Preferred)
• Portfolio Management Professional (PMP) (Preferred)

Responsibilities

• 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 the cycle and service processing times, ensuring that the functional E2E-process mapping is up to date and follows our Plan-to-Produce process.
• Consult and work closely with functional area managers and scheduler to optimize the production schedule daily.
• Utilize the Huddles to communicate appropriately and consult with the line functions, ensuring that 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 is 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.

Benefits

• Competitive pay
• Annual performance bonus
• Comprehensive Medical/Dental/Vision coverage
• 401(k) plan with employer contribution
• Paid vacation, personal and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees