Senior Manager, Biologics Drug Product Development

Otsuka Pharmaceutical Companies (U.S.)

. Provide technical leadership for Drug Product development activities across multiple biologics programs .

Posted 10/8/2026full-timeRemote • United StatesSenior💰 $150,034 - $224,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in formulation development for protein therapeutics, including automated aseptic filling processes and compliance with cGMP regulations. Proficient in statistical analysis and design of experiments (DoE) to optimize formulations and ensure product stability.

Highest-signal resume keywords

Formulation Development for Protein TherapeuticsAutomated Aseptic Filling ProcessesCGMP ComplianceStatistical Analysis and DoE ToolsTechnical Writing and Tech Transfer

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Applicant Tracking System Keywords

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Hard Skills

Formulation Design and CharacterizationStability and Stress StudiesFilling System Setup and OptimizationHigh-Concentration Protein FormulationsBiophysical CharacterizationControl Strategies and Validation ProtocolsContainer Closure IntegritySterile FiltrationExcipient ScreeningRisk Assessments and Change Control

Soft Skills

Technical LeadershipMentoring Junior ScientistsCollaboration with Cross-Functional Teams

Tools & Technologies

JMPMinitabQbD PrinciplesAnalytical Development Tools

Industry Keywords

CGMPAnnex 1ICH Q8/Q9/Q10ALCOA+21 CFR Part 11

About the role

Key responsibilities & impact

Provide technical leadership for Drug Product development activities across multiple biologics programs
Lead technical due diligence for Drug Product functions supporting in/out licensing opportunities
Lead formulation design and characterization for parenteral biologics
Design and optimize phase-appropriate formulations using QbD principles and DoE
Develop high-concentration and liquid-stable protein formulations
Conduct stability and stress studies and establish degradation pathways
Develop and execute shipping studies to establish and validate commercial shipping lanes
Perform or direct analytical and biophysical characterization studies with Analytical Development
Develop and scale automated aseptic filling processes from small/pilot scale through clinical and commercial production
Define and implement control strategies, validation protocols, and process characterization studies
Optimize and validate filling accuracy and precision; establish in-process controls and line setup procedures
Implement single-use fluid paths, component preparation, and sterile filtration strategies
Assess container closure systems and partner on vendor and component qualification
Author and review process descriptions, batch records, and tech transfer packages
Execute transfers to internal GMP or CDMO sites and provide on-floor support during engineering runs, PPQ, and campaigns
Author protocols and reports, contribute to CMC Module 3 sections, and support regulatory responses
Ensure compliance with cGMP and global health authority expectations
Lead or participate in FMEA risk assessments, deviation/CAPA resolution, and change control
Collaborate with Analytical Development, MSAT, Manufacturing, QA, Supply Chain, and Regulatory
Mentor junior scientists and contribute to portfolio planning and timelines

Requirements

What you’ll need

Degree in chemistry, biochemistry, chemical engineering, or biology and relevant practical experience 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
Expertise in formulation development for protein therapeutics, including 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
Experience with filling system setup and optimization using peristaltic, piston, or time-pressure systems
Experience with high-concentration proteins, viscosity management, syringeability/injectability, and device compatibility
Experience with visual inspection, container closure integrity, and leachables/extractables
Familiarity with sterile filtration and fluid path design
Practical knowledge of cGMP, Annex 1, ICH Q8/Q9/Q10, ALCOA+, and 21 CFR Part 11
Strong technical writing skills and experience with tech transfer to GMP or CDMO sites
Willingness to travel up to 25% of the time
Proficiency in statistical analysis, DoE tools, JMP/Minitab, and QbD control strategy development

Benefits

Comp & perks

Incentive opportunity
Comprehensive medical, dental, vision, and prescription drug coverage
Company-provided basic life insurance
Accidental death and dismemberment insurance
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
Generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company-provided benefits