PLD formulation scientist
The PLD team is at the forefront of innovation, developing groundbreaking Parenteral and Liquid drug product formulations and processes across our R&D Synthetics portfolio (small molecules, peptides, oligonucleotides),from late Discovery to Commercialization. This portfolio covers a variety of formulation types such as solutions,(nano)suspensions, liposomes, lipid-based systems, biodegradable microspheres and injectable biodegradable rods. The team is exploring various administration routes including oral, IV, IM, SC, intra-organ, intra-tumoral,topical, nasal, ophthalmic, transdermal, intrathecal and inhalation.
As Formulation Scientist within this team, you will be operating at the forefront of cutting-edge drug delivery technology. You will contribute to formulation development activities for state of the art liquid oral and injectable formulations of small molecules in (pre)clinical development stage. This will include participating in formulation design and process development strategies, execution of experimental design as well as hands-on manufacturing for process optimization, upscaling and technology transfer to support clinical trial manufacturing. In this capacity, you will collaborate closely with subject matter experts across different areas and contribute to scientific and technical advancements in this constantly evolving field. This position will include hands-on, lab-based research while offering scientific learning and growth opportunities.
Tasks & Responsibilities:
• Performs formulation and process development activities for innovative parenteral and liquid dosage forms across our R&D Synthetics portfolio.
• Designs formulations, performs hands-on laboratory work and captures results in electronic lab notebook and reports. Development activities span from preclinical to clinical phases.
• Develops expertise in assigned technical/scientific areas, searches the academic and patent literature to identify current best practices, gaps and IP opportunities relating to the scientific field, and translates new ideas into patient-centric solutions in support of drug development.
• Provides input for master batch records for clinical batches. Contributes to criticality analysis assessments and helps defining control strategies.
• Writes source documents in support of regulatory filings and provides scientific responses to inquiries from Health Authorities.
• Collaborates with various internal partners in Drug Development such as Pharmaceutical & Material Sciences, Analytical Development, Pharmaceutical Supply & Engineering Sciences, Quality, Legal, Supply Chain, and collaborates with external partners and CDMOs.
Qualifications & Experience
• Master’s degree with experience in a relevant field in Pharmaceutical Sciences / Chemistry / Bioengineering/ Chemical Engineering.
• Demonstrated experience in parenterals and liquids formulation and process development for synthetic drug compounds (small molecules) with focus on long-acting / targeted release injectables and a good understanding of physical pharmacy and particle engineering principles. Experience in aseptic/sterile processes, milling and nanonization techniques, and lyophilization is desired.
• A background in advanced drug delivery technologies such as drug nanosuspensions, biodegradable microspheres, injectable biodegradable rods, gels, liposomes is advantageous.
• Scientific rigor and curiosity, innovation mentality, critical thinking capabilities and problem-solving inclination.
• Excellent teammate with strong oral and written communication skills who thrives in a collaborative environment. Ability to partner with external (academic) networks and CDMOs.
• Ability to conduct hands-on experiments accurately and safely in a modern laboratory environment.