Job Description
This leader will create the environment in the group for collaboration across the interconnected, interdependent global network for all the areas of responsibilities within scope, demonstrating a Boundary less Organization mindset (right people, place, time). This includes personal engagement, sponsorship of active participation in management of knowledge, communities of practice, technical networks, product stewardship, technology platforms and best practices sharing in the flow of the core work.
Key responsibilities will include:
- Lead with Technical Excellence through: Commercial Manufacturing support, introduction of new processes to the site, supporting franchise/network investigations and initiatives, Regulatory strategies for filings and inspections and a relentless focus on problem solving through structured analysis underpinned by the Production System – MPS)
- Problem solving within the site Integrated Production Team (IPT) structures.
- Supporting experimental design, execution, data analysis and interpretation.
- Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
- Supporting deviation management and timely closure against site metrics.
- Supporting change control prioritization and implementation and compliant closure.
- Authoring and reviewing of batch documentation, technical reports, and global regulatory submissions.
- Supporting multidisciplinary teams (e.g. Manufacturing Science and Technology, Quality, Analytics, Regulatory) for process improvement and troubleshooting with end-to-end product focus.
- Serving as a key site Leader during internal and external inspections
- Lead and support various site and manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
- Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
- Top of Form
Your profile:
- This role requires an experienced individual with a minimum of 10 years’ (for PhD), 12 years’ (for MSc) or 14 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
Business Acumen and Financial Management
- In-depth knowledge of financial systems (budgets, expenses, product standards and variances.)
- Creates awareness of cost levers, driving productivity at all levels.
Problem Solving
- Gathers and analyses data and effectively responds to new, complex, or problematic situations; creates solutions that drive value for the Company and our customers, incorporating innovative approaches.
- Leverages the Production System (MPS) or equivalent tools, e.g. 8 step problem solving.
- Models and teaches scientific problem-solving approaches to group and peers.
- Demonstrates a lean mindset and drives continuous improvement.
Project Management
- Organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery and right first time by integrating with partner areas.
Strategic Thinking and Working across Boundaries
- Thinks and acts beyond one’s silo.
- Bridges boundaries across teams, functions, divisions, geographies, external stakeholders, and customers.
- Practices and sponsors Inclusive Behaviours and mindsets in the flow of work.
Productive Communication
- Plans and delivers ideas and information to others in a clear and impactful manner.
- Continuously communicates to align with partners and stakeholders.
- Communicates effectively with direct reports and employees.
Leadership & Managerial
- Sets clear performance standards including stretch goals for self and workgroup.
- Overcomes obstacles.
- Holds self and others accountable for achieving results.
- Works proactively to remove barriers to achieving and exceeding goals.
- Communicates a sense of urgency, high performance bars and changes to deliverables in a timely manner with workgroup and stakeholders.
Build Talent
- Utilizes standard performance management and talent management processes.
- Build diverse talent within the workgroup with the capabilities necessary for future success.
- Continuously assess competencies versus future needs and plan to fill gaps.
- Reward and develop employees to ensure individuals reach their full potential.
People Management
- Builds and invests in an Open, Collaborative, and diverse organisation culture.
- Is an experienced Coach and teacher of people.
- Demonstrated application of culture and business change methodologies (e.g. Change Execution Methodology, Inclusive behaviours, etc) when realizing site and cross functional process improvement initiatives.
- Demonstrates Inclusion and Leadership behaviours, including integrity, resilience, and flexibility.
- Ensures team members have the skills and capabilities to do their jobs.
- Maintains and develops empowerment.
- Ensures regular team communications using the Tier Process.
- Oversees conflict resolution.
- Oversees and carries out Performance Management, Talent Management activities, including employee development plans.
So, if you are ready to:
Current Contingent Workers apply
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