Company Overview:
Inno Core Pharmaceuticals is a biopharmaceutical drug delivery company located in the city of Groningen. We are the partner of choice for the development of long acting injectable drug delivery products with improved therapeutic efficacy and fewer side effects. We are recognized as a client-focused center of excellence with an unsurpassed drive to provide solutions for our rapidly growing international client base of pharmaceutical companies. Our multi-disciplinary team of around 40 experts is specialized in the development of microparticle-, gel- and implant-based formulations for sustained release of proteins, antibodies, peptides or small molecules for the treatment of a variety of chronic diseases. In addition to our highly versatile portfolio of proprietary biodegradable polymeric drug delivery technologies and an extensive track record in pharmaceutical development, we offer c GMP manufacturing of clinical supplies through a network of qualified CMO’s. Due to the success of our innovations we need to expand our team and we currently have a job opening for Associate Process Engineer in the Formulation & Process Development team.
Position Summary:
We are looking for a talented Associate Process Development Engineer with 3-4 years of experience in the pharmaceutical/CDMO industry to join our team. As Associate Process Development Engineer you will play a key role in the development, optimization, scale-up and transfer of processes from lab bench to GMP production scale. You enable the production of safe, effective, and high-quality parenteral sustained release formulations using Inno Core’s Syn Biosys® and In Gell® biodegradable polymer platforms. You ensure appropriate product quality, consistency, and have profound understanding of regulatory standards (such as FDA, EMA, and GMP) to secure timely CTM supply for our clients. On a daily basis you are supervised by Scientists or sr. Engineers and collaborate cross functionally (e.g. 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:

• Contribute to cross-functional project teams, including Formulation & Process Development, Analytical Development, Polymer R&D, Supply Chain, Quality Assurance, and Manufacturing.
• Coordinate, plan and lead the execution of various process and formulation development experiments to identify the optimal formulation, evaluate process parameters and to improve production yields and efficiencies.
• Collaborate with Analytical Development team in executing selected (physical) analyses.
• Support data interpretation from experiments and production runs to identify trends, troubleshoot issues and define, under supervision of Scientists or sr. Engineers, recommendations for further steps.
• Support the scale-up activities from lab to (external) GMP manufacturing.
• Participate in process performance monitoring to ensure timely completion of project objectives.
• Develop and maintain comprehensive process documentation, including batch records, forms, templates, reports, and standard operating procedures.
• Ensure compliance with FDA regulations, ICH guidelines, and other industry standards.
• Provide technical support during manufacturing operations, troubleshooting process-related issues as they arise.

Qualifications:

• Bachelor’s or Master’s degree in Chemical Engineering, Process Engineering, Mechanical Engineering, Pharmaceutical Sciences, or a related discipline.
• 4+ years pharmaceutical industry experience in process development.
• Strong understanding of pharmaceutical manufacturing processes, and requirements including aseptic processing, fill& finish, and lyophilization of parenteral formulations.
• Basic experience in process modeling, statistical analysis, and optimization techniques.
• Knowledge of regulatory requirements, including FDA and ICH guidelines.

Talents and Behaviors:

• Strong expertise and affinity with laboratory work in pharmaceutical development
• Good communication and interpersonal skills, able to work effectively in a team environment.
• Excellent analytical and problem-solving skills, with a data-driven mindset.
• Experience with process development methodologies and software (e.g., Do E, statistical analysis).
• Familiarity with quality management systems and risk assessment methodologies (e.g. FMEA).
• Ability to participate in multiple projects and prioritize experiments in a fast-paced environment.

The selection will be based on your skills and competencies.
What We Offer:

• Inclusive and supportive work culture.
• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth and career advancement.

Job Type: Full-time
Ability to commute/relocate:

• 9713 GX Groningen: Reliably commute or planning to relocate before starting work (Required)

Work authorization:

• Netherlands (Required)

Work Location: In person
Application Deadline: 30/11/2024