Manager, Product Development Expert Team (PDET) & Tech Transfer

Employer
CSL Behring
Location
Pasadena, California
Posted
Jun 05, 2022
Ref
R-168395
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Contract
Job Description

Summary of Role:

The Manager, PDET and Tech Transfer is part of a global team responsible for providing technical project management support within Biopharmaceutical Process Development.

The two main elements to this position are Product Development Expert Team (PDET) management and technology transfer of gene and cell therapy related processes and its associated analytics.

Using Technical Project Management principles, activities associated with this position include supporting TT Leads, CMC Leads, Biopharmaceutical Process Development departments and external testing laboratories to ensure success of BPD projects. This role is also responsible for supporting the planning, development, and coordination of the transfer of cell therapy related processes, including analytics between CSL sites and from and to external partners.

The role may also include responsibility for the coordination of outsourcing activities including analytical support, custom raw material manufacture, and equipment evaluations. Tech Transfer projects need to be intimately managed, goals set, progress measured against formal protocols while maintaining key relationships with internal and external stakeholders. The requirements of projects, internal customers and external customers must be met in terms of quality, cost and timeliness. Through exposure to the product development pathway and global bio-pharmaceutical trends, the role will also help guide R&D policy, support the preparation of regulatory packages, and identify new opportunities for cost savings and process efficiencies.

Reporting Structure:
  • This role reports to the Senior Manager, PDET and Tech Transfer in Pasadena.

Responsibilities:
  • Along with the CMC Lead, facilitate Product Development Expert Team (PDET) meetings, including provision of agendas, actions, and minutes.

  • Manage PDET related documentation.

  • Collaborate with department managers, CMC leads, and global project managers and develop detailed PD specific project plans.

  • Plan, develop and coordinate technology transfer activities associated with the R&D Pasadena site to and from other CSL manufacturing sites or external contract development or manufacturing providers.

  • Coordinate and/or write documents describing policy or procedures, interfacing where necessary with Subject Matter Experts.

  • Establishment and motivation of interdepartmental project teams.

  • Identification of new trends in the regulation of bio-therapeutics in relevant fields and ensuring CSL technology is best practice.

  • Act as a source of expert advice on all aspects of Technical Project Management and Technology Transfer while also transferring back into CSL knowledge obtained from external collaborations

  • Support the preparation of regulatory packages at each stage of the product lifecycle

Tech Transfer Responsibilities include:
  • Support the TT Lead and Tech Transfer teams

  • Ensure agreed targets for quality, yield and recovery, cost and timeliness are met

  • Plan work and resources

  • Write formal transfer protocols with measured deliverables and document project closure/completion through formal reports

  • Maintain full documentation and reporting using CSL’s Quality Systems such as implementing Change Controls via the TrackWise platform

  • Coordinate on-site evaluation and guidance of process transfer, assay transfer, quality systems, and cGMP production, where appropriate

  • Facilitate communications between internal and external stakeholders to ensure project targets are met

  • Generate cost estimates for projects for internal and external customers, provide budget forecasts and maintain tracking of ongoing project costs

Key Relationships (both internal and external)
  • BioPharmaceutical Development Teams

  • CMC Team

  • Global Project Management

  • R&D Quality

  • CMO Operations

  • Global Regulatory Affairs

Job Environment
  • Position is based at Pasadena, CA, USA

  • Minimal travel expectations.

  • Domestic and international travel, as needed.

POSITION SPECIFICATION

Essential Qualifications/Experience:
  • Bachelor’s degree in Biological Science, Engineering, or a related field.

  • An advanced degree (MSc, PhD) in Science or Engineering, PMP certification or equivalent is a plus.

  • At least 6 years hands-on experience in related process development activities.

  • Understanding of and experience in the production of bio-therapeutic proteins, including cell therapies, cell culture, chromatographic separation of proteins and other methods of protein purification, formulation activities, bio-analytical in-process and release assays, from bench-scale to commercial scale. 

  • Working knowledge of GMP/GLP regulations and application to manufacturing and clinical testing principles.

Essential Skills, Knowledge & Attributes:

  • Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions

  • Excellent work ethic, self-motivation, and ability to adapt in a dynamic team environment

  • Ability to lead successfully within extended, global multinational project teams and handle multiple challenges under pressure

  • Excellent organizational skills; proactive, management of multiple tasks of varied complexity simultaneously

  • Experience in Project Management would be an advantage

About Us

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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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