Manufacturing Technology SME

PM Group is currently engaged in the delivery of multiple Life Science projects in the USA. Together we will all be sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group’s ongoing expansion in the US. Outsourced Technical Services (OTS) is an integral part of our ability to support clients across the complete project life cycle. We deliver fast, flexible outsourcing solutions for clients worldwide. You will be on-site executing cutting-edge projects for Cell & Gene Therapy, Biologics, and Pharma facilities for both US and international clients.

PM Group is an employee owned, international project delivery firm with a team of 3,600 people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners.

Responsibilities

• Cross functional Team Leadership: Lead within cross functional teams to achieve facility start up and technology transfers. The Manufacturing Technology SME in the cross-functional team plays a critical role in ensuring that the facility fit, and technical transfer is successful, compliant, and efficient, while maintaining a strong focus on collaboration, communication, and quality.
• Technical SME: The role is responsible to represent the Engineering & Technology as facility fit and technical SME. Ensure appropriate equipment specification and procurement through qualification with the QAV SME. Raw material quality for use in manufacturing working in collaboration with PD and QC SME.
• Interact with process development teams on process design finalization (and control strategy as applicable) in terms of facility/equipment specifics, manufacturability, capacity and cost analysis, process controllability and robustness.
• Coordination and Communication: Facilitate effective communication and collaboration between different teams, departments, and stakeholders involved in the technical transfer process.
• Project Planning: Work with a project manager to develop a detailed project plan outlining timelines, tasks, resources, and milestones. This plan should consider potential risks, contingencies, and strategies to address any challenges that may arise during the transfer.
• Risk Management: Identify potential risks and challenges associated with the technical transfer process, and work with the team to develop mitigation strategies to minimize these risks. This could involve quality issues, regulatory compliance, equipment compatibility, operability, cost considerations and more.
• Regulatory Compliance: Ensure that all activities related to the technical transfer comply with relevant regulatory guidelines and standards.
• Quality Assurance: Collaborate with quality assurance and control teams to ensure that the transferred process or product maintains its quality, safety, and efficacy throughout the transfer process.
• Documentation: Ensure accurate and comprehensive documentation of all steps in the transfer process. This documentation is crucial for regulatory submissions, troubleshooting, and future improvements.
• Resource Allocation: Work with the project manager to ensure the necessary resources are allocated, such as personnel, equipment, and materials, to support the successful execution of the technical transfer.
• Problem Solving: Work proactively to address any issues or roadblocks that arise during the transfer process, working with the cross-functional team to find effective solutions.
• Execute technical assessments of new equipment, instruments, and single-use technology to identify optimal solutions in a fast-paced environment.
• Training and Knowledge Transfer: Facilitate the training of personnel involved in the technical transfer, ensuring that the receiving team has the necessary skills and knowledge to continue the process smoothly.
• Continuous Improvement: Identify real time opportunities for process optimization and improvement during the transfer, with the goal of enhancing efficiency, reducing costs, and maintaining or improving product quality.
• Conduct risk assessments/FMEA
• Be able to problem solve using systematic approach to root cause analysis.
• Owner and author of relevant documents which represent the process for GMP manufacturing including, but not limited to SOPs, process descriptions, master batch records, compounding records, critical raw material lists, bill of materials, part number and specification generation, sample map.
• Owner and author of process related change controls, deviations and CAPA to ensure events have no impact to process performance and product quality, and recurrence is eliminated.
• Assess and approve non-process related change controls, deviations and CAPA to ensure events have no impact to delivery of acceptable quality product and recurrence of issues are eliminated.
• Perform other responsibilities as required.

Qualifications

• Minimum Bachelor of Science degree in Biotechnology area, Biological Sciences, or Chemical Engineering.
• 7 years’ experience with biotech process development, process scale up, tech transfer or manufacturing in the biopharma/biotech industry.
• 3 years’ experience with functional or cross functional team leadership
• Demonstrated expertise with multiple tech transfer and scale up of biologic molecules for GMP clinical or commercial production, specifically in advanced therapies manufacturing example viral vector, RNA, cell processing.
• Prior direct experience in either design, qualification, start-up, or initial licensure of Biologics Manufacturing facilities preferred.
• Demonstrated evidence of detailed direct experience with process, equipment, single use technology, automation, validation, and facility fit knowledge.
• Thorough understanding and demonstrated experience with FMEA, risk analysis, process characterization or process validation.
• Knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development.
• Understanding of regulations pertaining to cGMP manufacturing and analytical requirements for Raw Materials, Critical Components, Drug Substance and Drug Product and the translation of those regulations into process development work products and GMP manufacturing process design.
• Experience with statistics in the areas of statistical process control, modeling, and data management.
• Computer skills (MS Office Suite, statistical software, Visio, LIMS, SAP, etc or equivalent).
• Ability to solve complex problems, and a proactive preventative mindset to enable flawless manufacturing.
• Strong interpersonal and communication skills - able to clearly express ideas and point of view both verbally and in writing
• Show commitment and dedication and strive to be ahead of schedule.
• Maintain on the floor presence to support oversight of operations in conjunction with Manufacturing Leadership - amount of time on the floor will be relative to the development of manufacturing associates as the organization is established.
• Practice safety awareness always and consider safety when establishing MBR and implementing changes for manufacturing.
• Share 24/7 on-call support while the product is being manufactured.

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our Corporate Responsibility and Heath, Safety & Well-being Report 2023.

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.

RECRUITMENT AGENCIES NEED NOT APPLY