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Job Title: Director, Process Engineering

Department: CMC

Location: Remote Switzerland

Overview Of Role

We are seeking an experienced bioprocess engineering professional to join the CMC team and support ongoing process development, technical transfer, BLA/IND/IMPD authoring and agency interaction activities, in preparation for commercialisation (and/or incremental clinical studies). In particular, this role will focus on leading & authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. This role will also contribute strategically and technically to future lifecycle considerations e.g. productivity improvements, scale-up vs. scale-out decisions etc..

The candidate must have a proven track record in supporting the development, scale-up, registration and manufacture of biologics processes. The candidate must also excel in communication and collaboration, as this role requires many interfaces both internal and external to Summit. The successful candidate will also be comfortable with change, being flexible to deal with shifting landscapes and new challenges.

Roles and Responsibilities

  • BLA/IND/IMPD Authoring
    • Be accountable to successfully deliver CMC chapters to regulatory documents
    • Develop and execute processes to ensure data integrity
    • Identify and close technical/content/compliance gaps
    • Collaboratively work across the broader CMC, regulatory and quality departments to deliver desired outcomes (including external vendors when applicable)
    • Actively support dialogue/interaction with regulatory agencies
    • Support PLI/PAI preparation and delivery
  • Strategic / Technical
    • Develop lifecycle management strategy
    • Understand key challenges and opportunities specific to product/process/supply chain
    • Prioritise post-approval opportunities and develop business cases for further investment/development
    • Support general problem solving and technical/strategic contributions across the CMC department/activities where applicable
  • Regulatory Compliance
    • Stay up to date on relevant regulatory requirements and guidelines related to biologics process development and manufacture
    • Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations.
  • Risk Management
    • Identify potential risks and challenges within the development and filing history of products and develop mitigation plans
    • Proactively address issues in the moment
  • Vendor Management
    • Oversee relationships with external vendors (where applicable), including CRO’s, consultants and technical services
  • Communication, Collaboration and Leadership
    • Subject matter and personnel leadership accountabilities
    • Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CRO’s/CDMO’s.
    • Participate in project team meetings to provide updates on subject matter status and address any issues or concerns.
  • Additional duties as assigned

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree in a relevant scientific discipline; advanced degree preferred
  • Minimum of 15+ years’ experience in bioprocess engineering, supporting the process development, scale-up and manufacture of biologics processes at a pharma, biotech or contract development and manufacturing organization (CDMO)
  • Experience with late phase product development, control strategy, validation and authoring/reviewing associated regulatory submissions
  • Broad understanding of regulatory and GMP requirements for late phase/commercial biologics products
  • Strategic thinker, ability to identify and prioritize action to maximize value and minimize risk over the mid to long term
  • Project management skills, tools, principles, and applications
  • Experience in overseeing external vendors
  • Proficiency in relevant software applications
  • Comfortable interacting with all levels of the organization, customers, and suppliers
  • Able to work with abstract global problems
  • Nimble in a highly dynamic and agile organization
  • Intuitive with well-honed interpersonal and communication skills
  • Organized and demonstrates effective team and subject matter leadership
  • Effective with global workgroup associates
  • A promotor of inclusion and collaboration
  • Able to work independently
  • Able to handle multiple projects simultaneously while maintaining high-quality results
  • Capable of providing and implementing innovative solutions to unique and pressing situations
  • Technically proficient in industry standard technology and/or available software, processes, and industry trends to streamline and or improve efficiencies
  • Knowledgeable of and compliant with SOPs, Change Controls, Deviations, Investigations and CAPAs
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