Senior Process Engineer

Senior Process Engineer


Position Summary:

We are looking for a talented Senior Process Development Engineer with 10+ years in the pharmaceutical industry to join our team. As Senior Process Engineer you play a key role in scale-up, optimization, and transfer of manufacturing processes. You enable the production of safe, effective, and high-quality parenteral sustained release formulations using InnoCore’s SynBiosys® and InGell® biodegradable polymer platforms. You ensure appropriate product quality, consistency, and compliance with regulatory standards (such as FDA, EMA, and GMP) in order to secure timely CTM or commercial batch supply for our clients. You work in the formulation and process development team and collaborate cross functionally (eg. with polymer-, analytical-, or quality experts and with (external) GMP manufacturing teams). You work typically on multiple projects, external as well as internal. You report to the Director Development.

 

Key Responsibilities:

  1. Process Development, Scale up and Transfer
  • Lead the scale up and optimization of processes for long acting injectables (small molecules, peptides, or proteins)
  • Collaborate with early development to translate lab-scale processes into commercially viable manufacturing strategies.
  • Ensure scalability and consistency from lab scale (tox batches), to pilot scale and further on to CTM and commercial production.
  • Lead the transfer of processes to (external) GMP manufacturing teams
  1. Process Optimization and Continuous Improvement
  • Analyze manufacturing processes to identify bottlenecks or inefficiencies and propose improvements.
  • Implement process enhancements to improve yields, reduce waste, and enhance product quality and consistency.
  • Employ Lean Six Sigma methodologies to drive continuous process improvement initiatives.
  1. Technical Support & Troubleshooting
  • Provide technical expertise and support troubleshooting for manufacturing issues related to process, equipment, or product quality.
  • Work with GMP manufacturing teams to resolve technical and process related deviations and ensure timely product release.
  1. Regulatory Compliance, Validation and Manufacturing support
  • Ensure processes comply with all relevant regulatory guidelines (FDA, EMA, GMP) and internal quality standards.
  • Apply QbD and risk based development (ICHQ8) and build product specific knowledge about relation between CQA’s and CMA’s, and CPP’s.
  • Conduct risk assessments (e.g. FMEA, HAZOP) to identify potential process risks and develop mitigation strategies.
  • Support manufacturing teams in equipment qualification (IQ/OQ/PQ), aseptic process validation (TSB) and generate appropriate documentation (protocols, reports) if required.
  • Support manufacturing teams to writing process validation plans, including performance qualification (PQ) and cleaning validation if required.
  1. Cross-functional Collaboration & Leadership
  • Work closely with R&D, manufacturing, QA, and supply chain teams to ensure smooth process scale-up and technology transfer.
  • Lead or participate in cross-functional teams for process scale-up and process transfer projects.
  • Collaborate with equipment and raw material suppliers to ensure compatibility and performance with manufacturing processes.
  1. Project Management:
  • Lead or support multiple process engineering projects simultaneously, ensuring timely completion, within scope, and budget.
  • Develop project timelines, resource plans, and status reports to communicate project progress to stakeholders.
  1. Training and Mentorship
  • Provide guidance, training, and mentorship to more junior staff.
  • Share technical expertise and best practices across departments to foster a culture of continuous learning and improvement.

 

Skills and Competencies:

  1. Technical Expertise
  • Strong knowledge of GMP manufacturing processes (e.g. aseptic processing in clean room, emulsification, lyophilization, extraction).
  • Proven track record with QbD, DoE and modeling tools to support scale-up and manufacturing process  control.
  • Expertise in process development, process scale-up, optimization, validation, equipment qualification (IQ/OQ/PQ), and cleaning validation.
  • Early and late stage development.
  1. Regulatory Knowledge
  • In-depth understanding of cGMP, FDA, EMA, ICH guidelines, and regulatory documentation.
  1. Problem Solving and Analytical Thinking
  • Ability to analyze complex process problems, identify root causes, and implement corrective actions.
  • Experience using statistical analysis tools (e.g., Minitab) to define process control strategy.
  1. Project Management
  • Proven project management experience with the ability to manage multiple, complex projects simultaneously.
  • Experience working with cross-functional teams and managing external vendors/suppliers.
  1. Leadership and Communication
  • Strong leadership and interpersonal skills to lead junior staff and collaborate with stakeholders at all levels.
  • Effective written and verbal communication skills, with the ability to clearly present technical concepts to non-technical audiences.

 

Qualifications:

  • A Bachelor’s or preferably a master’s degree in Chemical Engineering, Process Engineering, Mechanical Engineering, or a related discipline
  • 10+ years industrial experience in pharmaceutical (clinical) product development.
  • Of which 4+ years in a GMP functional area or support of a GMP functional area, such as Operations, Engineering, or MSAT.
  • Lean Six Sigma certification.

 

Talents and Behaviors

  • Possess a go-look-see mentality with a hands-on approach, closely involved in practical execution.
  • Adapt well to start-up and fee-for-service environments, demonstrating flexibility in responsibilities and managing shifting priorities to meet client project timelines.
  • Take initiative to lead and drive projects effectively.
  • Integrate R&D and GMP mindsets, bridging scientific understanding with GMP manufacturing practices.
  • Apply scientific expertise to GMP manufacturing processes.
  • Provide on-the-job training for junior team members in GMP manufacturing practices.

 

The selection will be based upon your skills and competencies.

 

What We Offer:

  • An inclusive and supportive work culture.
  • Competitive salary and comprehensive benefits package.
  • Various opportunities for professional growth and career advancement.

 

Application Process:
Interested candidates are invited to submit their resume and a cover letter highlighting their relevant experience to jobs@innocorepharma.com.

 

Deadline for Applications: 31st of December 2024

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