Senior Manager, Contract Development and Manufacturing Organizations

CSL Behring
Published
November 5, 2021
Location
King of Prussia, PA
Category
Job Type

Description

About CSL

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

Job Purpose

Manage and have oversight of 3rd party CDMOs supporting development and manufacturing of clinical products for Recombinant Product Development, Cell and Gene product development and Plasma Product Development areas within CSL Behring R&D.

Main Responsibilities and Accountabilities:

1. Lead selection of CDMOs in line with project strategies, defined business targets, technical requirements, and current procurement guidelines and processes

  • Manages, secures, and coordinates communication channels to assure SME and functional group alignment with regards to technical project deliverables and procurement/sourcing guidelines
  • In collaboration with requisite SMEs (PPD/RGPD/ESQA/ESI/Legal/Procurement/etc.) develops, negotiates MSAs/ SOWs and manages project execution

2. Business Management oversight of CDMO process development & clinical manufacturing and related tasks, in support of PPD and RGPD areas

  • Balance internal and external needs; Advocating CSL needs to the CDMO and CDMO needs to CSL to assure mutual success.
  • Identification and escalation of projects risks and mitigation strategies via joint project team meetings with CDMO/CRO

3. Manages communications both internally and externally within the business to deliver proposals, solutions, and mitigate conflict that will drive corporate goals.       

  • Develops and executes communication and escalation strategies as appropriate
  • Relays CSL Strategy for long term alignment with internal functions
  • Work with Execution Teams and to ensure CDMO/CRO contractual requirements for on-time in full delivery of clinical products are met, while fostering a culture of mutual accountability and trust

4. Responsible for management, issue resolution and escalation and prioritization of CDMO/CRO activities while meeting internal guidelines including but not limited to leading Joint Steering Committees, developing, tracking and reporting against KPIs for assigned partners.

5. Manages associated budgets and CDMO Spend, including PO generation and has oversight of related invoicing

Position Qualifications and Experience Requirements:

Education

MSc in Biochemistry/Biology/Chemistry, (Bio)chemical Engineering

Experience

  • 7 years of experience in biotechnological process development (multiple disciplines preferred) and or cGMP manufacturing, with direct experience leading global, cross functional teams.
  • 3 years’ experience managing CDMOs for the development and/or manufacture of biotechnological development of therapeutic proteins, gene therapy, and/or small molecules.
  • Previous experience in tech transfer, management and/or oversight of manufacturing processes for cGMP Drug Product sterile filling and related analytical testing.
  • Experience negotiating clinical and or commercial manufacturing agreements.

Competencies

Organizational Skills

  • Can multi-task and is able to prioritize conflicting demands. Is able to marshall or influence resources (people, funding, material and support) to get things done.
  • The ability to grasp new concepts quickly and to assimilate data from new sources
  • Ability to coordinate across cultures, time zones, and locations
  • Ability to proactively plan and execute on assigned projects. Can anticipate and adjust plans as required to achieve priorities. 

Communication skills:

  • Ability to communicate to meet the needs of the business
  • Ability to manage complexity and integrate regulatory requirements into CDMO deliverables
  • Recognizes confidential information and can manage the information accordingly
  • Excellent written and spoken communication skills (in English)
  • Can concisely provide the information people need to do their jobs and in a timely fashion.

Energy and drive

  • Has the ability to steadfastly push self and others for results. Can be depended on achieving results.
  • Has perseverance, will pursue tasks with energy, drive and personal commitment to meet deliverables.

Personal and interpersonal

  • Is customer focused.
  • Comfortable in exerting influence on cross -functional teams at multiple management levels.
  • Culturally sensitive. Can work across cultures and incorporate culturally appropriate communication styles into routine activities.
  • Demonstrates integrity and is trusted. Is able to maintain confidential information and admits mistakes.
  • Builds effective and constructive relationships, can utilize diplomacy and tact to comfortably diffuse conflict situations.
  • Maintains composure when under pressure and is able to handle stress without demonstration of frustration when challenges arise. Proposes solutions to challenges and drives for results.
  • Is an active and attentive listener and can accurately restate the opinions of others even when he/she disagrees.
  • Develops and maintains good peer relationships.

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