Scientist II - Downstream Process Development

FUJIFILM Diosynth Biotechnologies•College Station, TX

55d

About The Position

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.

Requirements

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
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.
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.
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.

Nice To Haves

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.

Responsibilities

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