The Downstream Process Development Scientist II functions to design, execute, and interpret 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 will typically lead customer process transfer projects. The individual should display good 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.
- Leads the technical transfer of viral and protein purification programs into Manufacturing with limited supervision
- Collaborates with cross-functional teams to deliver program milestones
- Manages project priorities with input from supervisor and/or department head
- Functionally supervise work of junior scientists across multiple process transfer projects with oversight from the supervisor
- Presents data both internally and externally in routine scientific meetings and may present outside of department to clients/customers/leadership.
- Authors and reviews protocols, scientific reports, and data presentations
- Works closely with process sciences and manufacturing group to assist and support process transfer into manufacturing
- Represents Downstream Process Development group during internal meetings and participates in customer-facing communications
- Cross-train in Upstream PD, Virology and Analytical Development groups to gain knowledge and functional capability in these areas
- Assists in and contributes to Process Development programs at the direction of more senior scientists
- Perform all other duties as assigned
Required Technical Knowledge and Experience
Individual will have broad 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
- Demonstrated proficiency in the operation of downstream processing equipment; chromatography (including the AKTA line of chromatography systems), UFDF, depth filtration, etc.
- Advanced understanding of liquid chromatography (IEX, HIC, Affinity, SEC, etc.), direct and tangential filtration, and centrifugation
- Thorough understanding viral and/or protein purification strategies
- Expert understanding of laboratory and chemical safety
- Excellent understanding of protein analytical techniques
- Good understanding of protein and viral biochemistry
- Experience with drug substance formulation and characterization
- Demonstrated experience with complex problem solving and/or prevention analysis affecting both PD and GMP activities
- Experience in a GMP setting and good understanding of cGMP regulations/procedures
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 reliably across multiple projects
- Ability to oversee junior scientists' work and provide positive guidance
- Takes initiative in finding opportunities to improve group functions and tasks, as well as continuously developing own technical skills and knowledge
- Proficient in the use of Excel, Word, PowerPoint, and familiar with Microsoft Visio.
- Produces consistent, excellent-quality work
- Consistently meets deadlines and communicates issues affecting program delivery in a timely manner
- Can solve complex problems arising during transfer and GMP activities
- Takes initiative in setting and achieving personal and professional goals
- Excellent organizational and stress-management skills
- 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 required skills & abilities):
- PhD in a science related field; OR
- Master's Degree in a science related field with four (4) years' of relevant experience; OR
- Bachelor's Degree in a science related field with six (6) years' of relevant experience; OR
- Associates Degree in a science related field with eight (8) years' of relevant experience.
- Experience in pharmaceutical or biotechnology industry.
- Hands-on downstream processing experience related to viral vector production.
- 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 email FDBTHR@fujifilm.com or call 979-431-3528.