Biologics DP Development Lead — Formulation & Filling

Otsuka; United States; Remote; USD 150.000 - 224.000; Vollzeit

Benefits dieser Stelle

Comprehensive medical

Dental insurance

Vision plan

Prescription drug coverage

401(k) match

Paid time off

Tuition reimbursement

Student loan assistance

Flexible time off

Paid holidays

Accommodations & leave programs

Zusammenfassung

Otsuka is seeking a Senior Manager to lead Biologics Drug Product Development, focusing on formulation development and aseptic filling for clinical and commercial programs. The role requires strong collaboration with external CDMOs and internal teams to drive robust, scalable processes.

The candidate will design high‑concentration formulations for monoclonal antibodies, oversee IQ/IQ/OQ/PQ activities, and ensure cGMP compliance across global operations.

Qualifikationen

• Bachelor's degree with 10+ years of work experience, or Master’s with 7+ years, or PhD with 5+ years in relevant field.
• Hands‑on experience developing automated aseptic filling processes for vials and/or PFS/cartridges in isolator/RABS setups.
• Experience with high‑concentration proteins (viscosity management, syringeability/injectability) and device compatibility.
• Familiarity with sterile filtration, and fluid path design (tubing, connectors, manifolds).
• Practical knowledge of cGMP, Annex1, ICH Q8/Q9/Q10, data integrity (ALCOA+), and 21CFRPart11.

Aufgaben

• Provide technical leadership for Drug Product development activities for multiple biologics programs.
• Lead due diligence activities for licensing opportunities.
• Design and optimize phase‑appropriate formulations using QbD principles and DoE.
• Develop and scale automated aseptic filling processes in isolator or RABS environments.
• Define control strategies, validation protocols, and process characterization studies in accordance with QbD.
• Collaborate with Analytical Development, MSAT, Manufacturing, QA, Regulatory; mentor junior scientists; contribute to portfolio planning.
• Lead risk assessments (FMEA), deviation/CAPA resolution, and change control.
• Prepare tech transfer packages and support regulatory responses.
• Ensure compliance with cGMP and global health authority expectations.

Kenntnisse

Formulation development

Aseptic filling

QbD & DoE

cGMP experience

Team leadership

Ausbildung

Bachelor's degree in chemistry/biochemistry/chemical engineering/biology

Advanced degree (MS/PhD) preferred

Tools

DLS

SEC‑MALS

CEX

icIEF

RABS/isolator systems

Jobbeschreibung

Otsuka is seeking a Senior Manager to lead Biologics Drug Product Development, focusing on formulation development and aseptic filling for clinical and commercial programs. The role requires strong collaboration with external CDMOs and internal teams to drive robust, scalable processes.

The candidate will design high‑concentration formulations for monoclonal antibodies, oversee IQ/IQ/OQ/PQ activities, and ensure cGMP compliance across global operations.