Immunomeinc·11 days ago
11 days ago
Senior / Principal Scientist, Formulation and Drug Product Development
Sign up free to see how well your resume matches this role.
What you'll do
- 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.
What they're looking for
- 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.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
The Senior / Principal Scientist, Formulation and Drug Product Development will lead formulation and drug product (DP) development activities for Immunome's ADC pipeline, with a strong emphasis on late-stage development, regulatory submissions, process validation readiness, comparability assessments, and product lifecycle management.
This individual will be responsible for developing robust, commercially viable drug product formulations and manufacturing processes for liquid and lyophilized biologics and ADCs. The role will provide technical leadership for formulation development, drug product process development, technology transfer, process characterization, control strategy development, and lifecycle management activities across clinical and commercial programs.
The ideal candidate will possess deep expertise in biologics and ADC drug product development and a demonstrated track record advancing products through Phase 3, BLA submission, commercial launch, and post-approval lifecycle management. This individual will thrive in a fast-paced biotech environment and be comfortable balancing strategic leadership with hands-on scientific execution.
Responsibilities
- 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.
Qualifications
- 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.
Washington State Pay Range
$155,896—$190,220 USD
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
Company
Immunomeinc
Bothell, United States of America
Company facts come from this company's own listings. We only show what the postings themselves carry.