Process Development - Scientist I - Downstream (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 Downstream Process Development Scientist I functions to assist in the planning of, execution, and interpretation of complex laboratory experiments and activities necessary for gene therapy, vaccine, and recombinant protein purification process development with priorities set by supervisor/project lead to achieve project goals. The individual may lead small customer or internal projects, and typically oversees the daily activities within ongoing projects under guidance of the project lead. The individual should display technical knowledge and scientific understanding of downstream purification of viruses, proteins, and plasmid DNA as well as having knowledge of process development at both small and large process scales
- Executes and monitors viral and protein purification processes, and assists with the development, scale-up, and transfer of these processes.
- Independently prepares, executes, and monitors liquid chromatography processes, and maintains FPLC chromatography systems (primarily the AKTA line of chromatography systems)
- Independently prepares, executes, and monitors direct and tangential flow filtration (TFF) operations
- Acts as a project and technical lead on projects of limited scope
- Maintains the process development lab and its equipment
- Reviews and edits development, transfer, and manufacturing reports
- Presents data internally in scientific meetings and communicates with clients on project status
- Authors and edits protocols, standard operating procedures, work instructions, and may prepare scientific reports and presentations
- Maintains detailed laboratory notebooks following FDBT procedures
- May represent the Downstream Process Development group during internal meetings
- Perform all other duties as assigned
Required Technical Knowledge and Experience
Individual will have working knowledge/expertise relevant to downstream processing of protein, virus, and plasmid DNA based products expressed in mammalian, bacterial, insect and yeast cells. Knowledge/expertise should be practical and focused on lab-related activities:
- Experience with general BSL-2 level laboratory techniques and maintenance
- Good understanding of liquid chromatography (IEX, HIC, affinity, SEC, etc.), direct and tangential filtration, and centrifugation
- Excellent understanding of viral and/or protein purification strategies
- Thorough understanding of laboratory and chemical safety
- Good understanding of protein analytical techniques
- Experience with troubleshooting and problem prevention and analysis affecting both PD and GMP activities
- Understanding and application of the scientific method in problem solving
- Knowledge of cGMP concepts.
Required Skills & Abilities:
- Excellent written and oral communication skills
- Ability to work closely with other members of a project group and receive constructive feedback
- Ability to work independently and realiably at the direction of project leads and/or senior scientists
- Ability to learn in a fast-paced, high-integrity, scientific group setting
- Ability to effectively train others on processing equipment and general lab procedures
- Takes initiative in setting and achieving personal and professional goals
- General knowledge of Excel, Word and PowerPoint
- Manages own priorities well and produces good-quality work
- The ability to work in team oriented environment is essential, as this person will work closely with other members of the Process Development Group and participate on multidisciplinary project teams.
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 and 6 years of relevant experience.
- Experience in pharmaceutical or biotechnology industry.
- Experience with GE/Cytiva's AKTA line of chromatography systems.
- 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.