Process Manager, Upstream MSAT

About the role

The Process Manager in the MSAT group is a functional project lead, who will independently design, execute, and support manufacturing activities and processes including technology transfer activities both from the client(s), Process Science and internally to GMP manufacturing facility.

Responsibilities

• Independent planning and design of demanding function-related tasks in customer projects, with pronounced interface management and complexity as a specialist/process expert
• Provide technical and strategic planning support for business development activities with respect to new client projects and new business initiatives
• Independent decision-making in changing processes and action patterns
• Direct communication and representation to our customers in face-to-face as well as virtual meetings for your own project section, which may include management of meetings
• Advising our customers on the specialist project strategy over the product life cycle
• Collaborating with Process Science for designing, supporting and developing scalable upstream for a broad range of biopharmaceuticals to include definition of required control strategies
• Transfer of customer processes (upstream) to internal and external production sites through execution of the New Product Introduction (NPI) process
• Ensure compliance with international technological and regulatory standards
• Responsible for meeting timelines and milestones according to the overall project plan to include management of resources to accomplish objectives
• Collaboration as a technical expert in an interdisciplinary and cross-functional project team
• Timely creation and review of protocols and reports
• Participation in customer audits and inspections by authorities
• Supporting the quotation process in collaboration with Business Development
• Onboarding and orientation of new employees
• Lead gap assessment between sites, tech transfer and Process Science and author of technical gap assessment report
• Support manufacturing for critical USP unit operations
• Review and approve Master Batch Record, SOP, and Fingerprints
• Provide Process training to manufacturing, technical operations, Quality assurance for the new campaign
• Authoring technical reports as required

Qualifications

Years of Experience (one of the following):

• A university degree in STEM and 8+ years of related experience
• A master's degree in STEM and 5+ years
• A PhD in STEM and 3+ years of experience

Preferred Technical Experience

• Expertise in Single Use Bioreactors and related process equipment, inoculum scale-up, large scale mammalian cell culture, Perfusion/continuous processing, Harvest processing to include depth filtration and centrifugation, scale up, and associated In Process Control (IPC) methods
• A familiarity with process control systems is essential
• Experience in GMP guidance, process performance qualification/validation (PPQ) and continued process verification (CPV)/Process monitoring
• Advanced ability with Microsoft Office (Word, Excel, Project, Visio, and PowerPoint), and Statistical analysis packages for data management and presentation
• Technical writing for memoranda, reports, protocols and similar documents

General Attributes

• The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills
• High level of initiative with an entrepreneurial mindset and analytical thinking
• Demonstrates ability to work both independently and as a member of local / global teams
• Excellent customer service skills and ability to meet client project deadlines
• Flexibility to switch between projects

Working Conditions

• GMP manufacturing environment working with biologics and chemicals
• Personal Protective Equipment must be worn as required
• Normal office working conditions
• Will interact with a cross functional team
• Pace may be fast and job completion demands may be high

Physical Requirements

• Frequent lifting up to 25 lbs
• Frequent standing/walking to work in GMP production environment for extended periods
• Frequent sitting for extended periods to use computer