Senior Manager, Biologics Drug Product Development

Otsuka Pharmaceutical Co., Ltd; Northern (KY); On-site; USD 150,000 - 190,000; Full time

Job summary

Otsuka Pharmaceutical Co., Ltd in the United States seeks a Senior Manager to lead formulation development and aseptic filling for clinically and commercially advancing biologics programs. You will guide parenteral formulations, high‑concentration protein systems, and automated filling lines in isolator/RABS environments.

Responsibilities include delivering DoE/QbD‑driven strategies, validating process characterization, and coordinating tech transfer to GMP/CDMO sites.

Qualifications

• A degree in chemistry, biochemistry, chemical engineering, or biology and experience in a cGMP environment.
• Bachelor’s degree with 10+ years of work experience, or Master’s with 7+ years, or PhD with 5+ years.
• Expertise in formulation development for protein therapeutics and stability studies.
• Hands-on experience with automated aseptic filling processes for vials/PFS in isolator/RABS setups.

Responsibilities

• Provide technical leadership for Drug Product development across multiple biologics programs.
• Lead due diligence for licensing opportunities in Drug Product.
• Develop and optimize phase-appropriate formulations using QbD and DoE.
• Design high-concentration formulations for monoclonal antibodies and complex proteins.
• Plan and execute stability, stress, and shipping studies; map degradation pathways.
• Oversee analytical/biophysical characterization (DLS, SEC-MALS, CEX, icIEF, CE-SDS).
• Develop and scale automated aseptic filling processes; ensure process transfer to GMP/CDMO sites.
• Contribute to CMC sections and regulatory responses; ensure cGMP compliance.
• Lead risk assessments, deviations/CAPA, and change control; mentor staff.

Skills

Technical Leadership

DoE & QbD

Stability & Biophysics

Cross-functional collaboration

Analytical Development partnership

Education

Bachelors in chemistry/biochemistry/chemical engineering/biology

Master’s degree

PhD

Tools

DLS

SEC-MALS

CEX

icIEF

RABS/isolator filling

Job description

**Senior Manager – Biologics Drug Product Development (Formulation & Filling)**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. In addition to hands-on experience, the ideal candidate will have experience partnering with and providing scientific guidance to external contract research, development and manufacturing organizations. 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. Experience with lyophilization is optional but will strengthen the applicant’s candidacy. The ideal candidate combines deep understanding of protein/excipient interactions and colloidal/physical stability with hands-on expertise in isolator/RABS-based automated filling lines with requisite clean room requirements, and GMP technology transfer.**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 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.**Automated Aseptic Filling Process Development*** 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.**Qualifications and Job Requirements****Basic*** 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.**Preferred*** 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.* Traveling up to 25% of time.* Statistical analysis proficiency (DoE tools, JMP/Minitab) and QbD control strategy development.**Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative.