Process Development - Scientist I - Upstream (Boston)
We are growing our locations and are investing more than $40 million for a new facility in Watertown, Massachusetts. The new process development and manufacturing facility will focus on viral vectors and advanced therapies.
The new site will host experimental and analytical equipment needed for viral vector and advanced therapy process development. The contract manufacturing services for early phase clinical trials are planned to begin at the site in 2023
The Upstream Process Development Scientist is responsible for assisting with the development of new cell culture and fermentation processes at laboratory scale, scale up to manufacturing scale, and transfer of client processes into Process Development as well as transfer of processes to Manufacturing. Projects include, but are not limited to, cell and virus culture, cell banking, batch and fed batch processing and in-process testing. The individual should display strong technical knowledge and scientific understanding of cell and virus culture, expansion, harvest, medium development, clone selection and development, and DOE studies, as well as having experience in process development with both small and large process scales. The individual will assist in and/or may lead a project and is expected to provide some scientific and technical contributions within the Process Development Group. They will work closely with other Departments to develop strong working relationships.
- Assist in the development, optimization, scale-up of bacterial and/or mammalian cell, including cell banking, adherent and suspension cell cultures in batch, fed-batch, and perfusion modes.
- Execute protocols for DOE studies that include appropriate statistical analysis and generate and present reports.
- Perform metabolite/spent medium analyses, medium development and cell line development studies.
- Assemble, operate, and troubleshoot single-use stirred tank bioreactors from bench scale to 200L working volume scale.
- Execute various centrifuge and cell/virus culture harvest protocols.
- Support GMP manufacturing through tech transfer, training, and master batch record generation and review.
- Assist with Generation of scientific reports, including process development reports, manufacturing summary reports, and supportive reports for IND CMC sections.
- Cross-train in Downstream PD, Virology and Analytical Development groups to gain knowledge and functional capability in these areas.
- Plan, perform and evaluate relevant in-process assays and report results.
- Generate and present oral presentations for peers and senior management, as required.
- Ensure maintenance and monitoring of process development equipment.
- Ability to work effectively in a matrix management environment.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Experience in upstream process development of mammalian, viral and bacterial cultures and upstream purification of biological products. Experience monitoring the performance of laboratory processes and equipment.
- Working knowledge of cGMP (current Good Manufacturing Practices).
- Ability to work independently and within a team.
- Ability to provide observations within a developing process.
- Strong attention to detail.
- Excellent verbal, written and organizational skills.
- Strong computer skills (Microsoft Office products including Excel, Word, Outlook and PowerPoint).
- Strong organizational and analytical skills.
- Strong interpersonal skills.
Preferred Skills & Abilities:
- Experience with cGMP operations, manufacturing, QA, QC, and regulatory requirements for pharmaceutical products.
- Experience performing Phase 1 clinical manufacturing.
- Experience in performing analytical methods supporting process development and/or GMP manufacturing.
- Strong background in virology and microbiology.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, along with some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to lift 50 pounds on occasion and 25 pounds regularly.
- Ability to wear PPE.
- Attendance is mandatory.
Minimum Qualifications(in addition to the required skills & abilities):
- Master's Degree in a science related field, with 1 year of relevant experience; OR
- Bachelor's Degree in a science related field, with 4 years of relevant experience; OR
- Associate's Degree in a science related field, with 6 years of relevant experience
- Degree in Chemistry, Biology, Life Sciences or related field.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.