Biomanufacturing Associate Iii - Waltham, United States - ElevateBio

ElevateBio

Verified Company

Waltham, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine.

Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

ElevateBio is looking for a dynamic individual to join and, contribute to building the manufacturing operations team at our BaseCamp facility.

The incumbent will ultimately perform routine cGMP manufacture of viral vectors supporting gene and cell therapy products including Adeno-Associated Virus (AAV) and Lentivirus (LV) at our state-of-the-art BaseCamp facility.

The individual should be a motivated self-starter eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise, have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards.

Here's What You'll Do:

Routine rightfirsttime cGMP manufacturing of viral vectors including but not limited to upstream, downstream, and aseptic fill finish and processing
Perform manufacturing/operations startup activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management
Provide constructive input on teams for the selection and setup of equipment, process and material flows, etc.
Create and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of viral vectors
Work effectively with cross functional teams comprised of process sciences, development, facilities & engineering, tech ops, quality control, quality assurance, to ensure rightfirsttime technology transfer
Work closing with Quality Assurance and Process Sciences to proactively resolve issues such as deviations, CAPAs, Change Controls
Commitment to the highest safety and quality standards in service of our colleagues and patients
Generate and manage batch records, run reports, batch data, etc. for manufacturing and scaleup activities
Proactively identify opportunities for improvements in process, safety, quality, and cost

Requirements:

Bachelor's degree in biological science(s) field or related engineering w/48 years of experience in cGMP biotech manufacturing preferred
High school equivalency w/610 years of experience in cGMP biotech manufacturing
48 years of experience in cGMP biotech manufacturing
26 years of viral vector manufacturing experience
Outstanding communication skills (verbal and written)
Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word
Demonstrate proficiency in aseptic technique and/or processing
Willingness to crosstrain in cell therapy manufacturing

Physical Requirements:

Employee will frequently stand, walk, bend, stretch for extended periods
Routinely carry up to 25 pounds and up to 50 pounds
Routinely push, pull, bend, kneel, twist, and climb step ladders while wearing PPE
Routine repetitive use of arms/wrist/hands
Ability to work nights, weekends, holidays as needed to support business needs
Ability to don jobspecific PPE

Why Join ElevateBio?
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come.

The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities.

The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:

To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:

We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

ElevateBio is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qua