layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior / Principal Scientist, Formulation and Drug Product Development at Immunome | LAYIQ

Lead formulation development for antibody, drug substance, and ADC drug products, including formulation screening, optimization, stability characterization, and development of commercial-ready formulations.
Serve as SME for formulation and drug product process development— including fill-finish, lyophilization, characterization, comparability, and lifecycle management; driving process scale-up and transfer to ensure manufacturability, robustness, and commercial readiness.
Lead formulation and drug product comparability strategies and assessments associated with formulation changes, manufacturing process changes, site transfers, scale-up activities, raw material changes, and post-approval improvements plans.
Establish and justify normal operating ranges (NORs), proven acceptable ranges (PARs), control strategies, and process characterization approaches for late-stage and commercial products.
Collaborate closely with Drug Substance Development, Analytical Development, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and Clinical teams to ensure alignment across product development and commercialization activities.
Author and review technical reports, comparability assessments, risk assessments, control strategy documents, development reports, regulatory submission sections (IND, IMPD, BLA, sBLA
), and technology transfer packages.
Support regulatory interactions and responses related to formulation development, process development, comparability, process validation, and lifecycle management activities.
Provide strategic leadership for product lifecycle management initiatives, including process improvements, manufacturing investigations, post-approval changes, and continuous process verification.
Evaluate and implement emerging technologies in formulation development, drug product manufacturing, fill-finish operations, lyophilization, and process characterization to drive innovation and operational efficiency.
Mentor and develop junior scientists and contribute to building internal drug product development capabilities as the organization grows.

A Bachelors, Masters, or Ph.D. degree in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field.
A minimum of 5 years of biotech/biopharma industry experience with a Ph.D., 8 years with a Master’s, or 10 years with a Bachelor’s degree, or equivalent experience.
Extensive experience in biologics and/or ADC drug product development, including lyophilized dosage forms.
Demonstrated success leading late-stage development programs through Phase 3, regulatory submission, approval, and/or commercialization.
Proven experience in formulation optimization, process characterization, comparability assessments, and drug product process development.
Extensive experience establishing NORs, PARs, design spaces, and control strategies to support process validation and commercial manufacturing.
Hands-on expertise in lyophilization cycle development, characterization, scale-up, validation support, and technology transfer for biologics.
Experience leading comparability assessments associated with process changes, formulation changes, manufacturing site transfers, scale-up, and lifecycle management activities.
Strong understanding of sterile drug product manufacturing, fill-finish operations, process validation, and commercial manufacturing requirements.
Demonstrated experience authoring and reviewing CMC documentation for INDs, IMPDs, BLAs, sBLAs
, and other global regulatory submissions.
Experience working effectively with CDMOs and managing external development and manufacturing activities.
Up to 10% travel required
, international and domestic.
Knowledge and Skills
Deep understanding of formulation principles for biologics and ADCs, including CQAs, degradation pathways, stability considerations, excipient selection, and container closure compatibility.
Expert knowledge of late-stage drug product development, process characterization, comparability strategies, process validation, and product lifecycle management.
Strong expertise in lyophilization process development, optimization, scale-up, technology transfer, troubleshooting, and commercial manufacturing support.
Demonstrated ability to establish scientifically sound control strategies using Quality by Design (QbD) principles and risk-based approaches.
Strong understanding of global regulatory expectations for clinical and commercial sterile drug products.
Expertise evaluating the impact of product and process changes on product quality and developing risk-based comparability strategies.
Strong analytical and scientific problem-solving skills with the ability to interpret formulation, stability, characterization, and process development data.
Excellent communication and influencing skills with demonstrated success leading cross-functional teams and interacting with external partners.

Senior / Principal Scientist, Formulation and Drug Product Development

Employer job description

Responsibilities

Qualifications

Equal opportunity and accommodations

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