BioProcess Science Manager
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The Manager, PPD-BPS team will be responsible for managing a team of scientists & engineers. S/he will be expected to hire and develop technical talents at all levels within the organization in line with CSL’s strategic objectives. In addition, s/he will be expected to keep abreast of new technologies and approaches and strategically employs these into the leading and executing lab-work geared towards improvement and optimization of protein separation/purification processes in order to increase safety, compliance, and/or commercial profitability.
- Process Development
- Process Engineering
- Data Analytics
- Global Pathogen Safety
- PPD CMC
- Global R&D QA
- Project Management (PM)
- Regulatory Affairs
- Operations Quality
- This position reports to the Director PPD Technical Operations, Kankakee.
- Positions that report into this position: 3-10 employees
Main Responsibilities and Accountabilities: List the roles and responsibilities of the position
As a member of the PPD BPS leadership team, s/he leads strategic thinking for the Process Improvement function through:
- Aligning functional outputs with Manufacturing Operations user requirements
- Aligning functional outputs with developments in Regulatory and Quality guidances (e.g. ICH Q8/9/10/11 and FDA/EMEA process validation guidance).
- Implementing best practices in bioprocess support (e.g. application of DOE methods, use of numerical risk assessments, application of principles of Quality by Design (QbD), implementation of value-added new technologies.
- Ensuring process improvement activities aligned with local site management objectives and prioritized appropriately.
- Ensuring Process Improvement team assess and utilize the most innovative technical approaches, where feasible, for the commercial product purification processes.
- Leading value-added partnerships (internally and externally) to accomplish Process Improvement objectives.
- Building an effective Process Improvement team by hiring the right skill set as well as career development in line meet the short- and long-term departmental needs.
- Preparation and assessment of performance objectives providing appropriate feedback across all levels of performance
- Sharing project updates to customers and senior management in timely manner.
As a hands-on manager of a technical team, s/he focuses on short to long term activities. Areas of responsibilities include:
- Ensuring agreed upon targets for quality, timelines, costs, and user requirements are met
- Planning project plans with clear goals, timelines, and resources.
- Effective partnership with Manufacturing, BPD, BLP, and GDC teams to identify feasible Process Improvement opportunities.
- Leading and executing protocol-driven Process improvement studies through effective utilization of DoE methodology.
- Scale up from bench, to macro (kilo scale), and pilot scale.
- Technical transfer to pilot scale and commercial scale.
- Process characterization and support for validation activities.
- Full documentation of Process Improvement activities according to appropriate Quality standards and in support of IP.
- Ensuring data integrity and scientific rigor in TO experiments
- Support of regulatory filings and regulatory audits as appropriate.
- Maintains awareness of cGXPs, good scientific practices, follow and promote lab and office safety.
- Provides effective and transparent communications to customers and stakeholders such as but not limited to, Process Engineering, Quality, Manufacturing, and Global and local R&D and site senior management.
Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.
Combination of academic qualification and appropriate* experience in biotech industry.
- e.g., B. Sc. in Bioprocess Engineering or Biological Sciences 7 years.
- e.g., M.Sc. in Bioprocess Engineering or Biological Sciences 5 years.
- e.g., Ph.D. in Bioprocess Engineering or Biological Sciences 2 years.
*Appropriate: A combination of protein purification, plasma fractionation or bioprocess R&D manufacturing technical support experience.
Essential Skills, Knowledge and Experience
- Technical knowledge of product life cycle management, process change management, biological licensure, and plant operations,
- Demonstrated implementation of innovative solutions,
- Experience with project management,
- Functional knowledge of pFMEA and QbD,
- Proven knowledge or expertise of DoE/statistical analysis.
- Demonstrated driving and implementation of innovative solutions,
- Demonstrated people leadership and talent development are highly preferred,
- Experience with project management,
- Plasma fractionation experience is highly preferred. In-depth knowledge and hands-on experience with Protein separation/Purification process optimization and scale-up/down are required.
- Business Acumen
- Decision Quality
- Problem Solving
Energy and Drive
- Drive for Results
Organizational Positioning Skills
- Organizational Agility
- Presentation Skills
- Written Communications
- Managerial Courage
- Managing and Measuring Work
- Priority Setting
- Time Management
- Results driven
Personal and Interpersonal Skills
- Customer Focus
- Ethics and Values
- Integrity and Trust
- Motivating Others
- Peer Relationships
- Team Player
- Positive spirit