Process Engineer - Sequoia Biotech Consulting
Watertown, MA
About the Job
Company Description
Sequoia Biotech Consulting is a leading life sciences consultancy, dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations. Our multidisciplinary team of scientists, engineers, quality experts, and business professionals specializes in optimizing product development, technology transfer, and commercial manufacturing. Additionally, we equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.
For more information, visit www.sequoiabiotech.com/.
What you will be doing:
We are seeking a Process Development Engineer with experience in engineering and technical roles, particularly within FDA-regulated manufacturing environments. The ideal candidate will have expertise in mRNA and LNP technologies, including downstream purification and RNA workflow optimization. This role involves supporting process development, scale-up activities, and ensuring compliance with cGMP and regulatory standards.
Is this job for you?
- Assist with the requirements specifications, design, functional requirements, development, commission and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.
- Assist with the risk assessments, feasibility reviews, risk mitigations and testing of process materials to ensure compliance with manufacturing requirements.
- Assist with the requirements specifications, design & development of process parameters and the commission/ validation of manufacturing processes for compliance with quality and regulatory requirements
- Provide technical support for the product/ process lifecycle and related activities
- Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed.
- Provide support for improvement projects regarding processes and systems.
- Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable
- Provide technical support of scale-up activities from development to manufacturing, including but not limited to; Technology Transfers, Facilities improvements (ie. utilities/ equipment integration, etc.)
- Analyze and recommend improved technology to increase quality and efficiency
- Provide technical analysis and support of new or improvements to process systems
- Ensure compliance with cGMP, regulatory, and industry standards
- Experience with site start-up projects and Technical background in Manufacturing Science & Technology (MS&T), Engineering, Process Development, and Manufacturing
- Development of novel circular mRNA purification and LNP formulation platform for delivery of highly pure drug substance, Cell/Gene Therapy production experience in GMP, R&D and Operations is a MUST. Spec equipment, order, set-up, troubleshoot, and maintain nucleic acid production, purification, and characterization equipment for optimal RNA workflow
- Experience with downstream purification, unit operations, column chromatography. column packing, tangential flow filtration (TFF), depth filtration and continuous manufacturing
- Design, lead, and drive experiments for screening, optimization, and scale-up purification of RNA
Who you are:
- Bachelor's degree in Engineering, Bio/Pharma Science or related technical field of study
- 4 - 7 years of related engineering and/or technical experiences required
- Background in managing start-up projects and Technical background in Manufacturing Science & Technology (MS&T), Engineering, Process Development, Manufacturing, etc.
- Experience with cGMP Manufacturing within a FDA regulated manufacturing company
- Knowledge of cGxP Quality Systems within a FDA regulated manufacturing company
- Knowledge of FDA regulations and guidance or applicable regulatory standards and practice
- Prior experience with AKTA and Cytiva production equipment used in scale-up is preferred.
We provide a comprehensive Total Rewards Program not limited to:
- Excellent healthcare options: Medical, vision, prescription & dental
- Family Focus & Balance: Parental leave, flexible time-off and Employee Assistance Program
- Financial Security: 401(k) with employer matching
- Tuition Reimbursement: Continuing education for every season of your career
- Employee Recognition Programs
Compensation
Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $106,991.88 yearly in our lowest geographic market up to $152,382.37 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
Legal Statement
Sequoia Biotech provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.
