[Hiring] Senior Manager, Biologics Drug Product Development @Otsuka Pharmaceutical Co., Ltd.

Role Description

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. 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.

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 stability.
  • Design and optimize phase-appropriate formulations using QbD principles and DoE.
  • Demonstrable experience in developing high-concentration formulations for monoclonal antibodies.
  • Conduct comprehensive stability and stress studies and establish key degradation pathways.
  • Develop and execute shipping studies to establish and validate shipping lanes.
  • Perform analytical/biophysical characterization in partnership with Analytical Development.
• Automated Aseptic Filling Process Development
  • Develop and scale automated aseptic filling processes in isolator or RABS environments.
  • Define and implement control strategies, validation protocols, and process characterization studies.
  • Optimize and validate filling accuracy and precision across various filling systems.
  • Implement single-use fluid paths and sterile filtration strategies.
  • Assess container closure systems for compatibility and E&L risk.
  • Author/review process descriptions, batch records, and tech transfer packages.
  • Ensure compliance with cGMP and global health authority expectations.
  • Lead/participate in risk assessments and change control.
  • Collaborate closely with various departments and mentor junior scientists.

Qualifications

• A degree in chemistry, biochemistry, chemical engineering, or biology.
• Relevant practical experience working in a cGMP regulated environment.
• Bachelor’s degree with 10+ years of work experience, or Master’s degree with 7+ years, or PhD with 5+ years.

Requirements

• Demonstrated expertise in formulation development for protein therapeutics.
• Hands-on experience developing automated aseptic filling processes.
• Experience with high-concentration proteins and device compatibility.
• Experience with visual inspection and container closure integrity.
• Familiarity with sterile filtration and fluid path design.
• Practical knowledge of cGMP, Annex 1, ICH guidelines, and data integrity.
• Strong technical writing skills and experience with tech transfer.
• Traveling up to 25% of time.
• Statistical analysis proficiency and QbD control strategy development.

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company provided basic life, accidental death & dismemberment insurance.
• Short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.

Application Deadline

This will be posted for a minimum of 5 business days.