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Principal, Process Engineer

3 months ago

Watertown, Massachusetts, United States Landmark Bio Full time

Landmark Bio is a pioneering company that converts revolutionary research into transformative medications. Launched in 2021 and headquartered in Watertown, Mass., Landmark Bio collaborates with industry leaders, academic institutions, and research hospitals to accelerate innovation in the life sciences field.

About the Role:

  • This is an exceptional opportunity to join a rapidly growing company dedicated to translating cutting-edge research into groundbreaking therapies.

Position Summary:

  • The Process Engineering role at Landmark Bio requires expertise in GMP biomanufacturing process engineering and New Product Introduction (NPI)/ Technology Transfer (TT) for Viral Vector, Fill finish, or Cell Therapy production. The ideal candidate should have Project Management experience and will be involved in supporting production with Engineering and Technology expertise post-transfer.
  • The successful candidate will work collaboratively in a fast-paced team environment, resolving complex problems creatively and practically alongside colleagues from various functions within the organization.
  • Position level will be determined by relevant experience.

Scope of Responsibilities

  • Project Planning: Develop detailed project plans, including resources, costs, timelines, tasks, risks, and mitigation strategies.
  • Project Management: Ensure team deliverables are clear, provide regular updates, and contribute to S&OP planning for project accuracy.
  • Resource Allocation: Allocate necessary personnel, equipment, and materials for successful NPI execution.
  • Risk Management: Identify and mitigate risks related to quality, regulatory compliance, and equipment compatibility.
  • Team Leadership: Lead cross-functional teams, guiding decision-making based on project philosophies.
  • Technical Responsibilities:
  • SME: Represent Engineering & Technology as the technical expert, ensuring process design aligns with facility capabilities.
  • Automation: Develop and implement equipment recipes for single-use process equipment.
  • Single Use Design: Collaborate with stakeholders to optimize single-use assembly designs.
  • Documentation: Write and manage GMP manufacturing documents, including process descriptions, batch records, and raw material lists.
  • Quality and Regulatory Compliance: Ensure NPI activities adhere to regulatory guidelines and standards.
  • Client Proposals: Assess process fit, define engineering requirements, and create detailed project plans.
  • Continuous Improvement: Identify and implement process optimization opportunities for cost reduction and product quality improvement.
  • Risk Assessments: Conduct risk assessments with cross-functional teams to manage business and quality risks.
  • Process Monitoring: Oversee daily process monitoring, including data analysis and presentation.
  • Additional Responsibilities: Perform other tasks as needed.

Qualifications

  • Education: Minimum Bachelor of Science in Biotechnology, Biological Sciences, or Chemical Engineering.
  • Experience: 10+ years in biotech scale-up, tech transfer, or manufacturing in the biopharma/biotech industry; 3+ years in team leadership.
  • Project Management Certification: PMP, CAPM, Agile, or equivalent certification preferred.
  • Technical Expertise: Experience in tech transfer and scale-up of biologic molecules for GMP production.
  • Facility Experience: Background in design, qualification, start-up, or licensure of Biologics Manufacturing facilities.
  • Problem-Solving Skills: Ability to address issues collaboratively during transfer and routine production.
  • Regulatory Knowledge: Understanding of cGMP manufacturing, analytical requirements, and industry standards.
  • Additional Skills: Proficiency in various software tools, strong communication skills, and commitment to safety and operational excellence.