Sr/Principal Scientist - Upstream Process Development

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The Sr./Principal Scientist, Upstream Process Development will be part of the Process Development Group reporting to the Director of Process Development. The role will have direct management responsibility for a team of Scientists and Research Associates. The Sr/Principal Scientist is responsible for the Upstream P rocess development, characterization, technology transfer and GMP manufacturing technical support. This individual will lead or contribute as a core member of various cross-functional teams, and interact extensively with other departments within Genezen , including Analytical Development, Manufacturing, Engineering, and MSAT. This is a client-facing position with regular interaction with our partners including external presentations, driving the technical discussion and program strategy.

JOB RESPONSIBILITIES

Provides technical oversight and strategic input for upstream viral vector drug substance development activities

Leads, proposes, manages, and coordinates activities on platform improvement/continuous projects in USP labs

Leads, manages, and supports late-stage development, by identifying tasks, planning, monitoring progress of deliverables, and in terms of protocol and report generation in areas such as scale-down model qualification, process characterization, and scale-down model process validation studies

Leads and supports technology transfer activities at pilot plant and when necessary, preforms experiments him/herself, focusing scale-up platform process at scale and process improvements implementation, process characterization at scale and bills of materials as well as sampling plans.

Provides MSAT and manufacturing technical Upstream SME support for process troubleshooting, manufacturing data analysis, root cause analysis, and deviations during GMP production, change controls, CAPAs, CCRs and other Quality Systems documentation as needed.

Designs and outlines experimental plans to meet the defined Genezen and client objective. Analyses and reviews experimental results and data.

Performs, optimizes, and maintains linear scale-down models. Writes, reviews, and approves electronic lab notebooks (ELNs) entries, experimental protocols, development reports, process descriptions, and scientific reports

Presents project progress and results internally to cross-functional teams and externally to clients/stakeholders

Maintains robust communication with all relevant functions that have an impact on or are impacted by Upstream Process Development

Coordinates and supervises the activities in the USP labs (with a team of engineers/ (Jr.) bioprocess technologist, co-op students, interns, temporary personnel (contractors), and technical SMEs and when necessary, performs experiments him/herself. Guides junior USP team members by setting goals/tasks on projects

SPECIAL JOB REQUIREMENTS

Adaptability required as work schedule may change based on business needs

Criminal background check required

Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

MSc with 8+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines

Essential

PhD with 6+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines

Desired

ON-THE-JOB EXPERIENCE

Process Development and Cell Line Development Experience

Essential

Upstream Processing Experience with Cell Culture, Bioreactor Technologies, and Transfection/Infection approaches

Essential

Prior work experience at a CDMO

Desired

SKILLS / ABILITIES

Hands-on experience on complex biologics, e.g. gene therapy, viral vaccines, therapeutic proteins

Essential

Experience with technology transfer and GMP manufacturing technical support

Essential

Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems

Essential

Effective communicator with track record of presenting data to relevant stakeholders including external stakeholders

Essential

Experience with DoE …