Coach and guide scientists and engineers for the execution of downstream development activities.
Ensure high‑quality experimental design, execution, data interpretation, and timely communication of results.
Scale‑Down Models, Scale‑Up & Technology Transfer
Design and qualify representative scale‑down models to support process characterization and comparability.
Support scale‑up to pilot, clinical, and commercial‑relevant equipment and consumables.
Author, review, and approve technology transfer packages, and support successful implementation at internal GMP sites and external CDMOs.
CMC & Regulatory Enablement
Contribute to and shape CMC downstream development strategies, including control strategy, in‑process monitoring, and operating ranges.
Author and review CMC‑relevant documentation (development reports, batch records, process descriptions).
Support preparation of regulatory submissions (e.g., IND).
Process Characterization, QbD & Risk Management
Lead process characterization and platform studies, including DOE‑based investigations.
Apply QbD principles, risk assessments (e.g., FMEA), and scientific justification to define design space and control strategy.
Drive root cause investigations, troubleshooting, and continuous improvement initiatives.
Innovation & Continuous Improvement
Identify and evaluate novel and next‑generation purification technologies (e.g., advanced chromatography, membranes, PAT/digital tools).
Champion platform evolution, efficiency gains, and robustness improvements aligned with long‑term modality strategy.
Documentation, Compliance & Quality
Ensure development activities adhere to cGMP concepts, data integrity, and Quality Systems expectations.
Author and review protocols, reports, development summaries, and technical documents at a high standard of scientific and regulatory quality.
Interface closely with Quality to ensure inspection readiness and compliance.
Minimum Qualifications
Education
M.S. with 10+ years, or Ph.D. with 7+ years of hands‑on industry experience in downstream process development.
Technical & Industry Experience
Extensive, hands‑on experience in LVV downstream process development (strongly preferred) or other viral vectors/biologics.
Deep expertise in clarification, chromatography, UF/DF (TFF), and sterile filtration.
Strong understanding of viral vector‑specific impurity profiles (HCP, host cell DNA, process residuals) and mitigation strategies.
Experience supporting clinical and/or commercial scale processes, including tech transfer.
CMC, GMP & Regulatory
Proven working knowledge of cGMP principles, Quality Systems, and relevant FDA/EMA guidance for gene and cell therapies.
Direct experience contributing to CMC sections of regulatory filings.
Data, Statistics & Risk Tools
Advanced experience with statistical analysis, DOE, and multivariate data interpretation.
Strong application of QbD, risk management, and process justification methodologies.
Leadership & Collaboration
Excellent written and verbal communication skills.
Demonstrated ability to lead in matrixed environments, influence stakeholders, and resolve complex technical challenges.
Preferred Qualifications
Track record of scaling LVV or viral vector purification processes from preclinical through clinical and commercial‑relevant equipment.
Experience supporting technology transfer to GMP manufacturing sites and CDMOs.
Exposure to PAT, digital tools, and data/knowledge management systems.
Demonstrated success in building and delivering next‑generation purification processes end‑to‑end.
The annual base pay for this position ranges from $142,377.60 - $213,566.40. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Closing Date 21-Oct-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
