CSL Behring Looking for Senior Director, Process Engineering, CMO’s and Product at King Of Prussia, Pennsylvania, United States of America Full Time

Summary:

The Senior Director, Process Engineering (virtual facility concept) is accountable to lead the process engineering teams, supporting CMO day-to-day business with process engineering and scientific knowledge and resources; focused on CMO execution and support; CMO point of contact for engineering, focused on process, system and technologies. S(he) is accountable for execution of all verification/commissioning, qualification and validation deliverables, Process technology engineering and Manufacturing Science and Technology aspects. This role leads managers with teams comprised of engineers, scientists, and project managers . Supports and understands all end-to-end functions, networks and needs from a CMO and ESI perspective and coordinates global function integration as needed.

In addition this leadership role is also accountable for product introduction and early LCM for Recombinant, MABs, Gene & Cell therapy, early product ownership/stewardship and specific process & technology ownership in this space. S/he ensures end-to-end product introduction (transfer from R&D or external products), health, quality and continuous improvement, focused on assuring product supply based on strategic planning, process & technology knowledge resources and expertise and be a key contact internally and externally.

This leader with his/her team works closely with Network Strategy to provide the necessary technical inputs to inform the strategy for near-term and long-term product demand and capacity for the products, processes and technologies in scope.

S/he leads a team of Product owner/stewards, Process & Technology owner globally in the space of Recombinants, MABs, Gene & Cell therapy. See also similarity in accountability with the job profile of Process engineer Product steward, Process & Technology owner for plasma derived products and in the fill/finishing space.

Responsibilities:

Accountability of PE CMO functions in the space of Process, System and Technologies a Manufacturing Science and Technology, Process Technology, Validation, TT representation and C&Q (in house and external contracts)

SPOC person representing all engineering function in the space of day to day operations and supports the CMO, ESI and global project execution.

Responsible for development of PE managers and staff, including motivating in a manner that promotes the achievement of CSL’s business goals and objectives.

Establish performance goals and strategic/operational objectives for department.

Coach, counsel, and appraise performance of personnel.

Develop staff competencies & capabilities to enable sustained success and career development.

Promotes high employee engagement and a positive work environment.

Responsible for organizational design, budget resource requirements and staffing decisions.

Drives changes & implements improvements through monitoring production activity and outputs in partnership with manufacturing, to effect the following:

• Real time process monitoring and data analysis trending in partnership with manufacturing
• Understands process variability and robustness on the floor to provide proactive and early observation of negative process trends and looks to eliminate or mitigate potential future performance challenges
• Understands and constantly tracks manufacturing and quality’s “day to day” challenges to ensure best support and allow improved performance anywhere in the production cycle from plasma to final product. Works to improve yield, increase process robustness, reduce costs, improve cycle times, improve throughput capacity, work toward zero deviation strategy
• Being the process, system and technology SME and owner “eyes and ears” on the floor in routine production and engages global PE and engineering function effectively
• Deliver and execute, Validation, C&Q and TT on site for the customers CMO and ESI

The detailed scope is subject of the arrangement with the individual CMO and in alignment with ESI Virtual Facility concept.

Deploys continuous improvement efforts from either internal identified needs or in implementing common or centralized process engineering improvement and modernization efforts

• Partners with COE TT/LCM to develop and enhance “Quality by Design” (QbD) life cycle management. This includes efforts to document current processes, continuous improvement of the process, the maintenance of QbD tools with new knowledge, data and experiences generated in end-to-end operations
• Drives process engineering technology ownership – manages and retires, as needed on site (following global standards)
• Execute process improvement in the sites in partnership with global PE and engineering functions
• Identification and prioritization of potential improvements resulting out of routine manufacturing
• Strive for integration of full automation and technical industrial standards, such as Industry 4.0

The detailed scope is subject of the arrangement with the individual CMO and in alignment with ESI Virtual Facility concept.

Key process engineering partner for ESI and CMO to manage changes, issues & improvements

• Partners with Quality, Manufacturing & R&D run process investigations such as root cause investigation. Focus on deviation prediction, prevention and continuous improvement in the space of Investigation and CAPA.
• Supports changes introduced through material science integration such as new filters, resins, raw materials. Supports second supplier strategy, vendor incoming material changes, global alcohol standard and other changes in partnership with PE material science group

The detailed scope is subject of the arrangement with the individual CMO and in alignment with ESI Virtual Facility concept.

As the CSL technical internal representative of PE functions for CMO and ESI, this role will be accountable for successful site implementation of global best practices, policies, and framework developed and by the Global Engineering organization.

• Develop a high-performing team of skilled PE all aspects practitioners who will execute projects in alignment with global network strategies, ESI and according to policies and practices developed by global centers of excellence.
• Provide leadership and direction for implementing new standards, cultural change and harmonization with site PE functions and their stakeholders.
• Represent PE function for CMO inspection readiness, execution, and responses. Coordinate the support of PE global and CMO-based SMEs as needed.
• Lead and direct staff providing PE expertise for issue resolution to support deviations or CAPAs and audit findings.

The detailed scope is subject of the arrangement with the individual CMO and in alignment with ESI Virtual Facility concept.

The role is following accountabilities and responsibilities of the PE Global Product steward, Process and Technology owner role (Plasma derived products and fill & finishing) in the space of Recombinants, MABs and Gene/Cell Therapy.

In addition is also accountable (from PE perspective) of the introduction of product coming from R&D or external partners in the space of Recombinants, MABs and Gene/Cell Therapy including early LCM stage after launch.

Qualifications:

Education:

Undergraduate/Graduate degree in Engineering or Scientific field. Advanced degree in a relevant Technical Field preferably combined with relevant post-graduate qualifications.

Experience:

• 15+ years or more working in Process Engineering, Operations or commercialization of biopharmaceutical products and processes in Pharmaceutical, Chemical Manufacturing or similar industry.
• Very strong knowledge in biopharmaceutical production processes and/or process development and validation.
• Strong data management knowledge.
• Demonstrated experience in process improvement development & execution
• Strong communication and conflict management skills to influence project professionals and stakeholders, including non specialists, at all levels in the organization
• Demonstrated experience in managing a multi-layered department across multiple technical specialties and global environment
• Demonstrated experience in managing, organizing, developing and deploying best practice frameworks, processes, tools and templates in an Operations context, in alignment with Enterprise standards
• 5 years or more experience working within a global Matrix organization
• Involvement in cross-functional, multicultural and international teams
• Must have a strong understanding of biopharmaceutical operations and relevant GMP regulations and regulatory guidance

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About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

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