Senior Scientist, Drug Product and Formulation Development

Position Summary

At ultracurious – Apply your biggest ideas in courageous ways
Looking for a highly motivated individual who has strong passion for science and pharmaceutical development, particularly for drug product and formulation development, as well as downstream process and clinical in-use activities.
The ideal candidate will demonstrate curiosity and commitment to understanding the product lifecycle from preclinical formulation to manufacturing, and end-user product handling and administration.
A drive for independent and cross-functional learning and collaboration is essential for this role.

Responsibilities

• Lead development and optimization of drug product processes for gene therapy products, including chromatography, ultrafiltration/diafiltration, formulation, mixing, filtration, filling, and freeze/thaw operations.
• Lead drug product (DP) process, formulation, characterization and clinical device development studies.
• Apply hands-on downstream development skills in the laboratory, designing and executing laboratory experiments, result analysis, documentation and presentations.
• Author and review technical protocols, study reports, investigation and scientific presentations, and generate, evaluate, and maintain data in a highly organized manner.
• Design and execute chromatography and purification experiments as necessary for formulation development, investigation, DP manual fill and finish for DP vial studies.
• Support the characterization of drug product manufacturing processes, including gap analysis, risk assessment, control strategy and investigation studies.
• Lead or support process parameter robustness study including impact analysis, studies of formulation and excipient impact on freezing, thawing, mixing, hold-time, filtering, filling and product contact on DP.
• Execute container characterization studies including primary container safety (extractables & leachables (E&L)) and impact analysis on product stability.
• Perform clinical device compatibility studies (Drug product with infusion sets, syringes, diluents).
• Support design and help with executing studies associated with drug product formulation stability, degradation pathway, container/closure compatibility, drug product hold-time, shipping, and handling robustness.
• Perform activities on developing formulation appropriate for various clinical administration methods (e.g., IV, SC, ICM, intrathecal), especially for novel modalities.
• Design, select, evaluate, and risk assess delivery devices (syringe pumps, catheters, IV sets, filters, etc.) and ancillary supplies by working with vendors and manufacturers.
• Support clinical readiness by developing or integrating rapid analytical tools (e.g., endotoxin testing, AAV genome titers, particulate matters, aggregation).

Requirements

• PhD or Master’s degree in Chemical or Biochemical Engineering, Biochemistry, Biology, Chemistry, Pharmaceutical, Pharmacy or related discipline.
• 5-8 years (PhD), 8+ years (Masters) relevant industry experience in drug product and formulation development.
• Hands-on pharmaceutical experience with drug product development for injectable therapeutics, including formulation process unit operations such as TFF, mixing, DS and DP filtration, DP filling and freezing / thawing.
• Hands-on experience of scale-up, tech transfer, and process characterization principles of the drug product manufacturing process at prior pharmaceutical companies.
• Familiarity with ICH, ISO and FDA guidelines, CMC documentations including protocols, reports, and regulatory requirements for IND, IMPD, BLA/MAA.
• Experience with drug product container closure systems and clinical device compatibility and safety including extractable and leachable.
• Familiarity with hands-on or at least solid knowledge in formulation and drug product analytics, such as: subvisible particle analysis, viscosity, turbidity, dynamic light scattering, UV, A260/A280, Bilayer interferometry, differential scanning fluorometry, Size exclusion-HPLC, qPCR and mass photometry, and mass spectroscopy a plus.
• Knowledge of process development for upstream and downstream purification, including ability to run chromatography using AKTA and Unicorn systems.
• Excellent communication and documentation skills, and ability to work effectively, follow-through in a collaborative team environment, including close collaboration with MSAT, AD, QC and clinical development/operation.
• Demonstrate team spirit and collaboration, sharing resources, while being cognizant of roles, responsibilities and timelines of program needs.