Senior Manager, Biologics Drug Product Development

Otsuka Pharmaceutical Development and Commercialization, Inc. is a pharmaceutical company expanding its biologics portfolio. The Senior Manager will provide technical leadership for biologics drug product development, including formulation design, characterization, aseptic filling process development, technology transfer, regulatory support, and collaboration with internal teams and external partners.

Responsibilities:

• 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
• 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-/lyoprotectants
• Demonstrable experience in developing high-concentration formulations for monoclonal antibodies and/or liquid stable formulations for complex/unstable protein architectures
• Conduct comprehensive stability and stress studies (thermal, agitation, freeze–thaw, light) and establish key degradation pathways (aggregation, fragmentation, oxidation, deamidation)
• Develop and execute shipping studies to establish and validate shipping lanes for commercial manufacturing and supply
• Perform (or direct studies at CDMOs) analytical/biophysical characterization in partnership with Analytical Development: DLS, SEC-MALS, CEX, icIEF, r/nr CE-SDS, subvisible particles, submicron particles, viscosity, osmolality, reconstitution profiles (for lyophilized formulations), and higher order structures
• Develop and scale automated aseptic filling processes (small- to pilot-scale through clinical/commercial) in isolator or RABS environments
• Define and implement control strategies, validation protocols, and process characterization studies in accordance with Quality by Design (QbD) principles
• Optimize and validate filling accuracy and precision across various filling systems including peristaltic pumps; establish IPCs (in-process controls), in-line weight checks, and setup for line clearance, sterile connections, and changeover
• Implement single-use fluid paths, component preparation (depyrogenation, siliconization oversight for PFS as needed), and sterile filtration strategies
• Assess container closure systems (vials, stoppers, seals, PFS, cartridges) for compatibility, E&L risk, silicone oil interactions, tungsten, break loose and glide force; partner to qualify vendors and components
• Author/review process descriptions, batch records, and tech transfer packages; execute transfers to internal GMP or CDMO sites; provide on‑floor support during engineering runs, PPQ, and clinical/commercial campaigns
• Author protocols/reports, contribute to CMC sections (Module 3), and support regulatory responses
• Ensure compliance with cGMP and global health authority expectations for aseptic processing and visual inspection
• Lead/participate in risk assessments (FMEA), deviation/CAPA resolution, and change control
• Collaborate closely with Analytical Development, MSAT, Manufacturing, QA, Supply Chain, and Regulatory; mentor junior scientists; contribute to portfolio planning and timelines

Requirements:

• A degree in chemistry, biochemistry, chemical engineering, or biology and 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 of work experience, or PhD degree with 5+ years of work experience
• Demonstrated expertise in formulation development for protein therapeutics: excipient screening, stability/stress studies, and biophysical characterization
• Hands-on experience developing automated aseptic filling processes for vials and/or PFS/cartridges in isolator/RABS setups, including filling system setup and optimization (peristaltic, piston, or time-pressure)
• Experience with high‑concentration proteins (viscosity management, syringeability/injectability) and device compatibility (syringes, autoinjectors)
• Experience with visual inspection (manual/automated), container closure integrity (CCI), and leachables/extractables
• Familiarity with sterile filtration, and fluid path design (tubing, connectors, manifolds)
• Practical knowledge of cGMP, Annex 1, ICH Q8/Q9/Q10, data integrity (ALCOA+), and 21 CFR Part 11
• Strong technical writing skills (protocols, reports, risk assessments) and experience with tech transfer to GMP or CDMO sites
• Statistical analysis proficiency (DoE tools, JMP/Minitab) and QbD control strategy development