Director / Senior Director, Analytical Development and QCJob SummarySeismic is seeking an analytical development and QC lead to join our growing Development team. You will lead analytical strategies and execution across our biologics programs targeting the adaptive immune system, combining scientific expertise with hands-on oversight of work performed at CDMOs, CROs, and other contract organizations following Seismic's highly externalized operating model.
You will bring deep analytical development and quality control expertise to lead analytical activities across Seismic's portfolio. Your primary responsibilities will include product characterization and comparability, analytical control strategies and specifications, method development, qualification, validation, and transfer, release and stability studies, and analytical lifecycle management. You will also provide analytical support for regulatory submissions. As an integral member of the CMC team, you will partner closely with colleagues to define and execute integrated development strategies.
This position may be filled at the Director or Senior Director level, depending on experience, technical leadership, and scope of prior responsibilities. Senior Director candidates should demonstrate broader ownership of analytical strategies across programs and leadership of complex CMC decisions.
Key Responsibilities- Provide analytical leadership across Seismic's biologic portfolio, aligning activities with program milestones, risk-based decisions, and regulatory needs.
- Develop and lead phase-appropriate analytical lifecycle management strategy for Seismic's pipeline of novel antibody and enzyme therapeutics. Integrate analytical development strategies in integrated CMC development strategies, aligning deliverables with program milestones and risks, and ensure clear accountability across programs.
- Manage outsourced analytical workstreams performed at CDMOs, CROs, and contract testing laboratories, including scope definition, timelines, budget, and performance management.
- Meet CMC timelines and program deliverables, communicate key technical and operational risks, drive cross-functional decisions and appropriate escalation to Seismic leadership to drive timely decisions.
- Define and implement analytical control strategies, including product characterization, key and critical quality attributes, raw material and in-process testing as appropriate, drug substance and drug product specifications, stability programs and supporting scientific justifications.
- Lead analytical development, optimization, qualification, validation, transfer, and lifecycle management. Assess method gaps and ensure methods are suitable for their intended use and development stage.
- Direct physicochemical, biochemical, and functional characterization of biologics, including monoclonal antibodies, Fc-fusion proteins, and other engineered protein modalities. Interpret structure, purity, impurity, and potency data, understand product quality, identify development risks and gaps, and propose and resolve risks and gaps.
- Design and oversee analytical comparability assessment for process, formulation, scale, site, and manufacturing changes, including study plans, interpretation, and scientific justifications supporting continued clinical development.
- Critically review analytical methods, protocols, qualification and validation reports, test data, certificates of analysis and testing, and technical reports. Maintain complete, traceable analytical records and communicate progress and risks to the CMC and Program Teams as appropriate.
- Partner with Quality and external laboratories to investigate and resolve atypical results, out-of-specification and out-of-trend results, deviations, and method performance concerns. Provide technical input to root cause analysis, corrective and preventive actions, and change controls as appropriate.
- Author, review and approve analytical sections of CMC regulatory submissions and maintain and organize analytical source documents. Provide analytical subject matter expertise responding to health authorities' questions and support regulatory interactions as needed.
Required Qualifications- Willingness to roll up your sleeves and take a hands-on approach to reviewing data and technical documents, investigating and resolving analytical issues, and driving activities to completion in a lean team environment.
- PhD, MS, or BS in analytical chemistry, biochemistry, chemistry, pharmaceutical sciences, chemical engineering, or a related discipline with 10+ years of progressive biotechnology or pharmaceutical industry experience, including substantial responsibility for analytical development of biologic therapeutics.
- Demonstrated expertise in analytical development for monoclonal antibodies, Fc-fusion proteins, and/or other engineered protein therapeutics, including the relationship between process development, product quality attributes, and analytical control strategy.
- Proven experience directing analytical activities at CDMOs, CROs, and contract testing laboratories, including technical oversight, troubleshooting, method transfer, data review, performance management, delivery against timelines and budget.
- Experience with analytical method qualification, validation, transfer, specification setting, reference standards management and qualification, stability studies, and comparability assessments for biologics analytical technologies, including chromatographic, electrophoretic, mass spectrometric, biophysical, binding assays, and cell-based potency assays.
- Extensive knowledge of cGMP requirements and applicable FDA, EMA, ICH, and other global regulatory expectations for analytical development of biologics, including experience contributing to CMC regulatory submissions.
Preferred Experience- Advanced degree (Ph.D. preferred) in a relevant scientific discipline.
- Experience advancing biologics from IND-enabling development through multiple stages of clinical development.
- Experience with phase-appropriate binding assays and cell-based assays for demonstrating product with product-specific mechanism-of-action for complex biologics.
- Experience establishing or refining specifications and analytical control strategies as programs transition from early- to later-stage clinical development.
- Experience leading comparability following process, formulation, scale, site, or manufacturing changes and responding to health authority questions related to analytical development.
- Experience working in a venture-backed biotechnology company or another lean environment where senior team members combine strategic thinking with hands-on execution.
Competencies- Ownership and accountability for outcomes, with urgency, attention to detail, and follow-through required to complete them reliably.
- Scientific and technical judgment, with the ability to use data and first principles to solve complex analytical development problems and make pragmatic recommendations.
- Collaborative leadership that builds trust across CMC disciplines and with external partners, supports clear functional ownership, invites input, and enables timely, well-informed decisions.
- Operational discipline, including working independently, maintaining clear documentation and visibility, proactively following up, and applying thoughtful risk-based thinking.
- Adaptability and learning agility in the face of ambiguity, changing priorities, and the hands-on work required to support an emerging pipeline.
- Ability to develop and implement a patient-focused analytical strategy, connecting analytical and CMC decisions to product quality, clinical execution, regulatory requirements, and the potential impact of Seismic's medicines for patients.
OtherThis role is based in Watertown, Massachusetts, with in-office expectations consistent with Seismic's company policies and business needs.
Travel domestically and internationally as needed to support analytical activities at CDMOs, contract laboratories, and other external partners.
The annual base salary range for this position is $195,000.00 - $300,00.00. The base salary is determined by several factors including, but not limited to, relevant experience, skills, qualifications, education and internal benchmarks.
