• Ensure reliable manufacturing of quality products in the areas of compounding, filling and packaging for validation purposes and commercial use
• Continuous improvement of manufacturing procedures, processes and related equipment in collaboration with MSAT, R&D and Quality departments
• Optimize Manufacturing output and labor efficiency while meeting required safety and quality levels
• Create an environment of strong team spirit and motivate and inspire teams to achieve ambitious goals in the short, mid, and long term
• Interface with leadership from across the Global Operations network and cross-functional representatives of different Roche Business Areas as well as with local Governmental/Regulatory officials
• Ensure that staff are appropriately trained and qualified for the activities they perform
• Manage and control expenses and investments towards the set targets
• Establish and maintain a culture of continuous improvement that generates tangible contributions to site operational performance
• Support innovation by the introduction of new technologies, manufacturing and business processes and information systems to address the changing environment, enhance existing operations and strive toward excellence in operations
• Ensure ‘Right to Operate’ through compliance with all global and local regulatory requirements applicable to RDSZ
• Maximize the service level to support the uninterrupted supply of high-quality products
• Ensure that all applicable Safety, Health and Environment requirements are fulfilled to comply with corporate group policy and local legal requirements
• Communicate the Roche Strategic Framework including the Group Business Model and the Group Management Model, reinforcing the Roche values Integrity, Courage, Passion and motivate the team to live them
• Contribute to RDSZ site activities as a member of the RDSZ Leadership Team

Skills: Manufacturing Reliability, Process Improvement, Output Optimization, Team Motivation, Cross-Functional Collaboration, Staff Training, Cost Control, Regulatory Compliance

• Develop and manage the manufacturing schedule and personnel
• Assess and qualify processes, facilities, procedures
• Coordinate manufacturing operations, generate and execute Batch Records
• Prepare and qualify new processes, equipment, and procedures
• Prepare operation reports, hire and train operators
• Interact with the engineering department to coordinate the maintenance
• Maintain a work environment that encourages high morale, action and results
• Ensure company objectives are understood and observed
• Build and lead the formulation team
• Establish and implement the formulation strategy for current and future products
• Develop QC methods to validate formulation materials
• Own technical and material transfers to contract manufacturers

Skills: Manufacturing Scheduling, Process Qualification, Batch Execution, Equipment Preparation, Operator Training, Maintenance Coordination, Team Leadership, Tech Transfer

• Ensure that, as the company grows, manufacturing capabilities meet or exceed all industry and customer requirements for cost, quality and responsiveness
• Work closely with the COO on manufacturing plans, goals, and future product innovations
• Lead plant operations and assist the organization in an upcoming regulatory inspection
• Be responsible for all aspects of Quality Control
• Effectively manage the incoming assay transfer for support of new products or enhanced control of existing products as part of continuous improvement
• Direct the company's manufacturing activities to ensure maximum effectiveness is obtained for the production of quality products within specified time and budgetary guidelines
• Be accountable to ensure products meet cGMP standards and required delivery schedules are met
• Interface with Product Development and Sales and Marketing to coordinate the production process for the introduction of new products
• Provide leadership in continuous improvement activities and successfully enable scalability to achieve goals of meeting quality, cost, and delivery objectives
• Direct all production control, production process development and shipping/receiving activities
• Lead the implementation of new initiatives from the M&SC senior leadership team
• Lead the department to achieve the agreed yearly goals on time with quality
• Lead the manufacturing ERP system design and implementation successfully 

Skills: Manufacturing Scalability, Regulatory Readiness, Quality Control, Assay Transfer, cGMP Compliance, Product Launch, Process Development, ERP Implementation

• Build on a positive business culture to drive engagement and pro-activity
• Deliver operational performance whilst maintaining the highest standards of safety and quality
• Identify long-term strategic opportunities around the utilization 
• Manufacture footprint and investment opportunities
• Develop the existing leadership team to provide career progression opportunities to support the growth of the business
• Work with the board to ensure the business continues to be recognized as best-in-class, whilst also supporting new business opportunities
• Directly supervise, monitor and build solid relationships with all present and future potential clients including carrier, OEM/ODM, EMS, etc.
• Accountable for achieving Manufacturing BU targets, business results, and managing the P&L of Manufacturing BU
• Provide strategic and tactical direction to the manufacturing BU and drive continuous improvement of the business
• Form deep partnerships with the other functional business leaders across the organization to ensure synergistic collaboration
• Develop and monitor the operating budget, productivity, contract negotiations and recommend capital projects for the manufacturing BU
• Directs and coordinates overall plant operations, guiding to resolution of issues identified in manufacturing processes
• Delineate an operational schedule to comply with the goals and customers' orders, and the manpower available

Skills: Business Culture, Operational Performance, Strategic Planning, Leadership Development, Client Relations, P&L Management, Cross-Functional Collaboration, Budget Oversight

• Lead a team of IE staff to continuously meet or exceed the plant and departmental goals and objectives
• Lead the IE team in planning for the utilization of facilities, equipment, materials, and personnel to maintain and improve efficiency
• Lead the IE team in operating with a high level of efficiency, integrity, and enthusiasm, striving to achieve excellence in all endeavors
• Lead and manage the IE group towards achieving the departmental goals and objectives
• Identify individual strengths of the Engineers, and develop training needs
• Coach and mentor the IE group to deliver excellence to internal and external customers
• Create and manage a succession plan for IE functions
• Prepare timely and accurate forecasts for the department
• Responsible for the implementation of major engineering projects within the scope of the department
• Running the daily business to fulfill the targets
• Coach and develop the production team to improve the efficiency of the organization
• Drive the improvement projects
• Approves and oversees the implementation process, as well as ensuring work is completed in the required time frame and within budget requirements
• Works with the global manufacturing VP and cross-site teams to implement the global manufacturing strategy

Skills: Team Leadership, Efficiency Planning, Staff Development, Goal Achievement, Mentorship Skills, Succession Planning, Project Implementation, Global Strategy

• Experience in a pharmaceutical, biotechnology or cell and gene therapy cGMP environment
• Proven track record in product development at a senior level within the Cell and Gene Therapy field
• Strong reputation as a scientist and leader in the industry
• Deep understanding of CAR T cell or NK cell manufacturing 
• Extensive experience and expertise in cGMP cell therapy (or biologics) and aseptic manufacture
• Strong leadership, risk management and project management skills
• Function building and staff development experience
• Expertise in problem-solving and leading investigations
• Excellent communication, interpersonal and collaboration skills
• Ability to work within cross-functional teams
• Attention to detail and well-organized
• Willingness to think outside of the box and adapt best practices in a constantly evolving environment
• Self-motivated with a strong sense of ownership and accountability in areas of responsibility
• Ability to be innovative within the constraints of a cGMP environment with a drive to reduce cost-of-goods
• Experience working in a fast-paced, entrepreneurial, high-growth setting 

Qualifications: BS in Materials Science with 5 years of Experience

• Regulatory experience including audits, organizing and writing regulatory submissions, and personal interactions with manufacturing regulatory bodies
• Good knowledge and understanding of Quality requirements
• Demonstrated ability to work closely with management and regulators
• Strong and proven leadership capabilities
• Proven managerial skills such as self-motivation, enthusiasm and ability to interact within a multi-disciplinary environment with multiple stakeholders
• Broad and significant experience in Biopharmaceutical development and manufacturing with a strong background in the manufacture of CAR T cell or NK cell technologies
• Understanding of and exposure to multiple gene editing or engineering delivery technologies
• Comprehensive and demonstrated experience of CMC development from Research through registration and ongoing technical and scientific support post approval
• Experience in educated risk-based decision making through the development life cycle
• Experience in presenting and defending development strategies and processes at FDA/EMA / PMDA meetings
• Experience with CMC regulatory requirements for ATMP products
• Ability to train and coach colleagues to improve overall team process knowledge
• Demonstrated track record of delivering positive results consistently

Qualifications: BS in Biochemistry with 6 years of Experience

• Proven project management skills for technical programs
• Ability to grasp complex technical issues and make sound decisions based on data and information from various sources
• Track record of success in leading cross-functional teams
• Communication excellence through multiple media
• Ability to deliver objectives on time in pressurized, fast-paced environments, whilst also meeting all compliance, quality and cost targets
• Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority
• Ability to initiate and drive through change programs
• Experience of business partnering at a senior level
• Experience in managing technical teams
• Experience in implementing and leading continuous improvement projects
• Industry experience at the management level in the manufacturing sector
• Ability to understand the bigger picture, find a way and just get things done
• Naturally analytical with strong attention to detail, able to break down problems and use the team to develop and implement solutions

Qualifications: BS in Cell Biology with 4 years of Experience

• Previous experience as an Engineering Manager in a high-demand, dynamic environment, including experience in developing the team
• Working experience in batch manufacturing (one-offs, prototypes, etc.)
• Experience or at least substantial exposure to manufacturing processes such as turning, milling, CNC and manual, grinding and mechanical assembly
• Experience with mechanical assembly or fabrication
• Understanding of fabrication work and processes
• Experience with materials including metals, plastics, and composites
• Experience with a management system, whether in Excel or an ERP or MRP system and harnessing it to aid traceability, predictions and workflow management
• First-class organisational, time management and interpersonal skills
• Ability to multitask and meet targets and deadlines
• Ability to manage a heavy workload and conflicting priorities without compromising on output or accuracy
• Great leader, quick to earn respect and motivate people to improve the work environment
• Possess an organised and thorough approach to work
• Strong professional image, generating immediate personal credibility
• Strong work ethic and ability to work on own initiative

Qualifications: BS in Molecular Biology with 7 years of Experience

• Prior experience with electro-mechanical products
• Prior experience in Medical Device Manufacturing or the regulated industry 
• Prior manufacturing experience in high complexity products
• Experience in process development, scale-up, tech transfer and/or manufacturing
• Leadership experience with management responsibilities
• Excellent knowledge of biopharmaceutical / pharmaceutical plants and unit operations
• Understanding of manufacturing enterprise systems, electronic batch management and having a broad overview of site-level interactions
• Knowledge of Lean and/or Six Sigma methodologies
• Excellent trouble shooting, problem solving and communication skills
• Demonstrates high commitment to cGMP, EHS and people development
• Good interpersonal skills and the ability to work in a team environment
• Able to understand interactions/ complexity of different manufacturing expertise, for example, Upstream processing/Downstream processing/ Equipment Preparation/ Buffer
• Demonstrate a thorough understanding of various products and their respective processes
• Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure

Qualifications: BS in Pharmacology with 6 years of Experience