CMC Lead, Director

Employer
CSL Behring
Location
Kankakee, Illinois
Posted
Oct 07, 2021
Ref
R-149297
Discipline
Science/R&D, CMC
Hotbed
BioMidwest
Required Education
Doctorate/PHD/MD
Position Type
Full time

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!

Job Description

Position Purpose

This senior leadership role will be responsible for project-specific Chemistry, Manufacturing and Control (CMC) teams accountable for CSL plasma product development (PPD) projects.  The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM). During early clinical development, the CMC Lead defines the manufacturing plan and ensures clinical supply.

To accomplish these objectives, the CMC Lead will provide strategic direction, technical expertise, coordination and oversight of cross-functional, global and local CMC teams including representatives from Process Development, Analytical Development, Global Pathogen Safety, Technology Transfer, Quality, Regulatory Affairs, Validation, Manufacturing, and Quality.

Main Responsibilities and Accountabilities:

1. In close collaboration with R&D and operations, defines and ensures execution of the phase appropriate process, analytical, and manufacturing programs

  • For clinical development, define needs based on non-clinical and clinical study designs and application
  • For Life Cycle Management (LCM) projects, defines manufacturing operation development targets
  • Oversight of process scale-up and transfer activities
  • Responsible ensuring process/product characterization and comparability after process changes
  • Accountable for development of process control strategy including leading development of product specifications in a cross-functional team.

2. Ensures alignment on and communication of CMC strategies, objectives, and deliverables

  • Regularly reports to Core Project Teams, Steering Committees and established governance bodies on progress against deliverables, timelines, and project risks
  • Reset priorities, request additional resources and make key decisions about directions for the CMC delivery teams

3. Accountable for delivery of the Quality Section during clinical development, market authorization, and LCM changes for the CSL PPD projects including:

  • Participating in the process scale-up and technology transfer activities within CSL Behring production sites;
  • Contributing to the strategic aspects of product characterization, comparisons, manufacturing trending, trouble shooting and process changes, including a coordinated and well-structured dossier of reports;
  • Maintaining line-of-sight for all other aspects of the development process in Validation, QA, QC and Engineering, including ensuring a consistent and coordinated approach to their respective studies and reports;
  • Maintaining line-of-sight on all aspects of site manufacturing delivery (contracts, production, coordination, validation, regulatory activities).

4. Ensures appropriate and continuous communication with Research, Development, and global CMC groups relating to topics interfacing with CMC and associated activities.

5.Accountable for CMC/QbD related project and product documentation (for example: risk assessments, PFMEAs, monitoring strategies,…) in accordance with global CMC/QbD policies

6. Executes globalization/ harmonization initiatives across sites that drive efficiencies, establishes best practices, and return values to CSL Behring.

Position Qualifications and Experience Requirements:

Education

Ph.D., Masters, or BSc (or equivalent) in Biochemistry, Biology or related field

Experience

Minimum 10 years of experience in pharmaceutical industry with emphasis on manufacturing operations, process design, and process validation. Demonstrated experience in project management and or leadership by influence preferred. Advanced knowledge of biological manufacturing processes and advanced CMC/QbD requirements for plasma derived or biotechnology therapies is preferred. Technical and regulatory writing experience. Previous experience working across sites and as part of international teams is highly desirable.

Competencies

  • Language: Fluency in German is a strong asset
  • Superb Leadership: An outstanding demonstrable track record of leadership and results, coupled with a performance driven approach. Motivates, inspires and influences others across the organization and enterprise to achieve results in line with company strategy. Strong leadership skills to lead teams in a global setting, understand needs of customers/stakeholders, use proactive approaches to meet their needs in an effective and timely manner, and to build and maintain effective working relationships
  • Technical: Understands the fundamental patient safety strategies and GMP related aspects for assuring the safety of biological products. Understands scale-down models and critical aspects of relating performance of these to large scale operations. Understanding of biological product manufacturing requirements and process validation.
  • Teamwork: Demonstrated ability to work effectively with and help others on interdisciplinary teams to accomplish objectives. Fosters a working atmosphere conducive to collaborative efforts.
  • Customer Service: Understands customers/stakeholders and takes a proactive approach to meeting their needs in an effective and timely manner. Builds and maintains effective working relationships and partners with customers.
  • Planning and Prioritization: Plans and organizes work activities for self and team, if applicable; manages several tasks at once. Responds with a sense of urgency to time-sensitive issues. Translate insights into solutions that create value and challenge the status quo; lead and adapt to change; taking and managing risks appropriately
  • Cross cultural sensitivity and flexibility: Works effectively across varied and different international conditions. Understands and respects differences in people and cultures.
  • Initiative: Identifies opportunities and issues and proactively acts and follows through on work activities to capitalize or resolve them. Ability to act in a complex and rapidly changing environment
  • Data Gathering, Analysis, Problem solving, Integrity: Seeks or collects and synthesizes information from a variety of stakeholders and sources in an objective, unbiased manner. Uses analytic skills and methods to solve difficult problems with effective solutions, is excellent at honest analysis, demonstrates and promotes high standards of ethical conduct.
  • Results Oriented: Focuses on desired results and sets and achieves challenging goals. Demonstrates a flexible approach to new tasks. Develops tools and techniques to create work efficiency and achieve outcomes in timely fashion.
  • Strong Technical Writing Skills : Superior writing and presentation skills.
  • Attention to Detail: Ensures information is complete and accurate; follows up with others to ensure that deliverables are complete and commitments are fulfilled.