Biologics Drug Product Development, PI-AD

We are seeking a highly motivated and experienced Drug Product Development (DP) professional to lead formulation and drug product development activities for biologics programs. The successful candidate will be responsible for developing robust formulations and drug product processes for monoclonal antibodies, fusion proteins, recombinant proteins, ADCs, and other biologics from preclinical development through clinical and commercial stages.
This role requires both strong technical expertise and demonstrated leadership capabilities, including team management, project leadership, and cross-functional collaboration.

Key Responsibilities
Drug Product Development
Lead formulation and drug product development activities for biologic drug candidates, including monoclonal antibodies, fusion proteins, recombinant proteins, and ADCs.
Design and execute formulation screening, optimization, characterization, and stability studies.
Develop liquid and lyophilized formulations suitable for clinical and commercial applications.
Evaluate formulation excipients, container closure systems, and drug delivery devices.
Identify technical risks and implement mitigation strategies throughout product development.
Support technology transfer, process validation, and commercial readiness activities.
CMC and Regulatory Support
Contribute to CMC development strategies and ensure alignment with program objectives.
Author and review regulatory documentation for IND, CTA, BLA, and other global submissions.
Collaborate with Regulatory Affairs to address health authority inquiries.
Ensure development activities comply with relevant regulatory guidelines and industry standards.
Team Leadership
Build, mentor, and lead a team of scientists and research associates.
Provide technical guidance, coaching, and career development support to team members.
Manage resource allocation, project prioritization, and performance management.
Foster a collaborative, innovative, and high-performing team culture.
Cross-functional Collaboration
Work closely with Process Development, Analytical Development, Manufacturing, Quality, Regulatory Affairs, Clinical Development, and Project Management teams.
Manage external CRO/CDMO activities and ensure project deliverables are achieved on time and within budget.
Present development strategies, project updates, and technical recommendations to senior management.
Qualifications
Education
Ph.D. degree or above in Pharmaceutical Sciences, Pharmaceutics, Biochemistry, Biotechnology, Chemical Engineering, or a related scientific discipline.
Experience
3-8 years of industry experience in biologics drug product/formulation development.
Demonstrated experience in the development of protein therapeutics, monoclonal antibodies, or other biologic products.
Proven experience leading projects and managing scientific teams is required.
Experience supporting clinical-stage and/or commercial biologics programs is highly desirable.