Principal Scientist - Upstream Process Development - Onsite - Marlborough, MA

Sartorius•Marlborough, MA

1d•Onsite

About The Position

Sartorius’ Emerging Therapies Services team in the Greater Boston (MA) area is a part of Corporate Research Group and is engaged in the design, development, and optimization of next generation viral vector and monoclonal antibody engineering and manufacturing processes that can be transformed from early pre-clinical stage into cGMP ready manufacturing scale. The incumbent is expected to work closely together with an internal multi-disciplinary product development team, to create forward looking processes that provide a basis for commercial manufacturing that can be integrated into our process solution offering. This is an exciting opportunity to drive the creation of new innovative biomanufacturing solutions, Sartorius has formed an initiative to discover new trends and cutting-edge opportunities for rapid conversion towards next generation continuous and integrated closed manufacturing solutions. This exciting initiative enables the research, process development and clinical production of novel modalities using next generation manufacturing platforms, in partnership with key customers. What you will accomplish together with us Design and optimize protocols for the culture and growth of primary cells and cell lines (e.g. HEK, CHO and Vero) using cutting-edge techniques aimed at enhancing the efficiency and scalability of the processes. Lead cross-functional teams, to scale primary cell and cell line expansion and from benchtop to production scale bioreactors. Develop and write process development proposals, conduct hands-on laboratory work to optimize and troubleshoot upstream manufacturing processes for Viral Vectors, mAbs and other biologics. Analyze and interpret data ensuring clear documentation of methodologies and outcomes. Prepare detailed reports and presentations for internal and external partners to communicate progress in line with project schedules. Assist in mentoring and training junior team members and coordinating the day-to-day operations. Lead and manage multiple high impact internal and external research projects by establishing priorities, milestones, schedules, and deadlines. Responsible for writing, reviewing, and maintaining electronic lab notebooks with the highest level of research integrity. Responsible for writing project reports, briefs, protocols and making presentations to internal and external partners and project teams as required. Lead technology transfer activities to internal and external collaborators. Support marketing efforts by writing technical briefs, application notes and peer reviewed publications, leading or assisting with technical presentations at scientific conferences. Conduct technical investigations and risk assessments related to processes Support generation of protocols, work instructions, batch records and reports. Work independently in a matrixed environment. Perform occasional extended hours and weekends to support ongoing lab activities as needed. Mentor and support junior staff and build a culture of support and collaboration. Comply with all site policies such as record retention, ISO requirements, and accountable for good housekeeping in all laboratories. Comply with biohazard, special clean room and site safety/health procedures and guidelines as required. Assist other team members and site management team with miscellaneous duties when requested.

Requirements

Master's with 10+ years of industry experience or a Ph.D. with 6+ years of industry experience in chemical, biochemical or biomedical engineering, engineered cell therapies or related field.
Extensive expertise in culturing cell types relevant to advanced therapy applications.
Expertise in adapting existing cell culture processes from planar to 3D bioreactor systems.
Strong analytical and mathematical ability.
Ability to work independently and constructively in a team environment.
Must have strong personal initiative and be results oriented.
Strong troubleshooting skills.
Experience with documentation control systems.
Familiarity with relevant guidelines from the FDA, EMA and ICH
Strong written and verbal communication skills, capable of clearly expressing technical concepts to people with various levels of technical expertise and diverse cultural backgrounds.
Identification with our core values: Sustainability, Openness, Enjoyment

Nice To Haves

Hands-on experience with microcarrier-based suspension culture and single cell cloning is a plus.
Knowledge of GxPs, experience in process development or GMP operation is a plus.
Demonstrated ability to design, plan, and implement pluripotent cell differentiation protocols.
Experience in the design and execution of current molecular biology and biochemical assay techniques including PCR, qPCR, ddPCR, NGS, WB, IF, ELISA, and Flow Cytometry is highly desirable.
Experience & knowledge of state-of the-art upstream and downstream technologies for cell growth, transfection, propagation, and purification for application for process development workflow.
Experience working as part of multi-partner R&D projects.

Responsibilities

Design and optimize protocols for the culture and growth of primary cells and cell lines (e.g. HEK, CHO and Vero) using cutting-edge techniques aimed at enhancing the efficiency and scalability of the processes.
Lead cross-functional teams, to scale primary cell and cell line expansion and from benchtop to production scale bioreactors.
Develop and write process development proposals, conduct hands-on laboratory work to optimize and troubleshoot upstream manufacturing processes for Viral Vectors, mAbs and other biologics.
Analyze and interpret data ensuring clear documentation of methodologies and outcomes.
Prepare detailed reports and presentations for internal and external partners to communicate progress in line with project schedules.
Assist in mentoring and training junior team members and coordinating the day-to-day operations.
Lead and manage multiple high impact internal and external research projects by establishing priorities, milestones, schedules, and deadlines.
Responsible for writing, reviewing, and maintaining electronic lab notebooks with the highest level of research integrity.
Responsible for writing project reports, briefs, protocols and making presentations to internal and external partners and project teams as required.
Lead technology transfer activities to internal and external collaborators.
Support marketing efforts by writing technical briefs, application notes and peer reviewed publications, leading or assisting with technical presentations at scientific conferences.
Conduct technical investigations and risk assessments related to processes
Support generation of protocols, work instructions, batch records and reports.
Work independently in a matrixed environment.
Perform occasional extended hours and weekends to support ongoing lab activities as needed.
Mentor and support junior staff and build a culture of support and collaboration.
Comply with all site policies such as record retention, ISO requirements, and accountable for good housekeeping in all laboratories.
Comply with biohazard, special clean room and site safety/health procedures and guidelines as required.
Assist other team members and site management team with miscellaneous duties when requested.

Benefits

Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings
Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules
Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform
Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.
Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate
Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service