Senior Manger, Biologics Drug Product Development

Senior Manager - Biologics Drug Product Development (Formulation & Filling) To support our rapidly expanding biologics portfolio of assets, we are seeking a highly skilled technical leader to join our Biologics Drug Product Development team with a primary focus on formulation development and aseptic filling process development for clinical and commercial programs. In addition to hands-on experience, the ideal candidate will have experience partnering with and providing scientific guidance to external contract research, development and manufacturing organizations. This role will lead formulation design and characterization for parenteral biologics (e.g., mAbs, recombinant proteins, novel biologics modalities) and develop/scale automated filling processes across vials and prefilled syringes. Experience with lyophilization is optional but will strengthen the applicant's candidacy. The ideal candidate combines deep understanding of protein/excipient interactions and colloidal/physical stability with hands-on expertise in isolator/RABS-based automated filling lines with requisite clean room requirements, and GMP technology transfer. Key Responsibilities Technical Leadership Provide technical leadership for Drug Product development activities for multiple biologics programs. Provide technical leadership for the due diligence activities in support of Drug Product function for in/out licensing opportunities. Formulation Development Deep understanding of Protein sequence, structure and function relationship and the impact of charge distribution and excipients on the short-term and long-term stability. Design and optimize phase-appropriate formulations using QbD principles and DoE, considering pH, buffer systems, ionic strength, surfactants, tonicity agents, antioxidants, bulking agents, cryo-/lyop