Process Development Specialist

il y a 4 jours

France, FR Barrington James Temps plein

Job Title: Process Development Specialist – Engineering Background (Sterile Drug Products)


Job Overview:

We are seeking a highly skilled Process Development Specialist with a strong engineering background to join our team. The ideal candidate will have extensive experience in the commercial manufacture/scale-up of sterile drug products, bringing a deep understanding of process development, optimization, and troubleshooting in a regulated environment. The role will be pivotal in advancing the development of manufacturing processes, ensuring smooth scale-up from laboratory to commercial production, and maintaining the highest standards of product quality and compliance.


Key Responsibilities:

  • Process Development & Optimization:
  • Lead the development, optimization, and scale-up of processes for the manufacture of sterile drug products, ensuring they meet regulatory standards and quality requirements.
  • Collaborate with cross-functional teams to design and implement efficient, robust, and scalable processes for commercial production.
  • Conduct process characterization and risk assessments to identify potential issues and implement mitigation strategies.
  • Manufacturing Scale-Up:
  • Oversee the transition of processes from R&D to commercial-scale manufacturing, ensuring a seamless scale-up and minimizing production delays.
  • Provide technical expertise to resolve scale-up challenges and optimize production efficiency while maintaining product quality.
  • Work closely with operations teams to support the establishment of commercial manufacturing processes.
  • Regulatory Compliance & Documentation:
  • Ensure that all processes and procedures are compliant with FDA, EMA, and other relevant regulatory agencies.
  • Prepare and review process development reports, batch records, and other regulatory submissions.
  • Ensure that all manufacturing processes are validated and meet Good Manufacturing Practice (GMP) standards.
  • Continuous Improvement:
  • Identify opportunities for continuous process improvement, cost reduction, and efficiency gains within the sterile drug product manufacturing process.
  • Lead or participate in root cause analysis and corrective/preventive action (CAPA) investigations for process deviations or failures.
  • Collaboration & Leadership:
  • Work closely with the quality, engineering, and manufacturing teams to drive innovation and ensure timely delivery of projects.
  • Mentor and provide technical guidance to junior staff and cross-functional teams as required.
  • Present findings, process improvements, and technical updates to senior management and other stakeholders.


Required Qualifications:

  • Education:
  • Bachelor's or Master's degree in Chemical Engineering, Biomedical Engineering, Pharmaceutical Engineering, or a related field.
  • Experience:
  • Minimum of 5-7 years of experience in process development, scale-up, and commercialization of sterile drug products.
  • Proven track record in commercial manufacturing and scale-up of sterile dosage forms (e.g., injectables, biologics, or other sterile formulations).
  • Experience with process validation, technology transfer, and GMP in the pharmaceutical or biotechnology industry.
  • Technical Skills:
  • Strong knowledge of sterile manufacturing processes, including aseptic processing, filtration, lyophilization, and other related technologies.
  • Expertise in process modeling, data analysis, and process control systems.
  • Familiarity with quality systems, regulatory requirements, and industry best practices.


Other Skills:

  • Strong problem-solving, analytical, and troubleshooting skills.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Ability to manage multiple projects and priorities in a fast-paced environment.


Preferred Qualifications:

  • Experience in process automation and advanced manufacturing technologies.
  • Familiarity with statistical process control (SPC) and other process optimization tools.
  • Advanced degree (MSc or PhD) in engineering or related field.
  • Six Sigma or Lean Manufacturing certification.


Why Join Us?

  • Opportunity to work with cutting-edge technologies in the pharmaceutical industry.
  • Collaborative and dynamic work environment.
  • Competitive compensation and benefits package.
  • Professional growth and development opportunities.

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