Biologics Drug Development Lead — Formulation & Filling

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 150,000 - 224,000; Full time

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager to lead Biologics Drug Product Development with a focus on formulation and aseptic filling for clinical and commercial programs. You will guide cross‑functional teams and external partners to ensure robust, scalable processes.

Responsibilities include strategy development, tech transfer, and risk management within a cGMP framework, with travel up to 25%.

Qualifications

• Bachelor's degree with 10+ years of work experience in biologics DP development or advanced degree with 7+ years
• Experience in formulation development for protein therapeutics and high‑concentration formulations
• Hands‑on experience with automated aseptic filling lines in isolator/RABS environments
• Strong knowledge of QbD, DoE, analytical characterization and regulatory expectations

Responsibilities

• Provide technical leadership for Drug Product development activities across multiple biologics programs
• Lead due diligence for licensing opportunities related to Drug Product
• Design and optimize phase‑appropriate formulations using DoE and QbD principles
• Develop and scale automated aseptic filling processes for vials and PFS
• Collaborate with Analytical Development, MSAT, Manufacturing, QA, Regulatory; mentor junior scientists

Skills

Formulation development

Aseptic filling process

QbD principles

DoE (Quality by Design)

cGMP experience

Tech transfer

Risk assessments (FMEA)

Project leadership

External collaboration

Education

Degree in chemistry/biochemistry/chemical engineering/biology

Tools

JMP

Minitab

Job description

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager to lead Biologics Drug Product Development with a focus on formulation and aseptic filling for clinical and commercial programs. You will guide cross‑functional teams and external partners to ensure robust, scalable processes.

Responsibilities include strategy development, tech transfer, and risk management within a cGMP framework, with travel up to 25%.