Lyophilization Process Development Scientist

Employer
Arranta Bio
Location
Gainesville, FL, United States
Posted
Nov 05, 2020
Ref
85503-313113
Required Education
Doctorate/PHD/MD
Position Type
Full time
ABOUT US

Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio's mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.

WHO ARE WE

Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.

Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.

We embrace our challenges as opportunities.

We are empowered to think and act.

We never settle; we strive to improve through purposeful creativity.

We build aligned teams who learn, grow, and deliver.

We are committed to building strong relationships.

Are you ready to come ALIVE with a daring and intrepid team? Don't wait another minute; Apply today!

JOB SUMMARY

We are seeking a highly motivated individual to join the Process Development team as a Lyophilization Process Development Scientist. The position will focus on developing lyophilized formulations and executing unique methods required for the development of robust, scalable and reproducible formulations and processes for Live Biotherapeutic Products (LBPs). This position will work closely with the Drug Substance, Analytical, Quality Control, Process Development, Drug Product Manufacturing and Quality Assurance teams on the end-to-end Drug Product Development of LBPs.

ESSENTIAL RESPONSIBILITIES
  • Develop lyophilization cycles, internal scalable fermentation processes, and processes to increase stability of microbiome LBP drug products.
  • Perform analytical assays as needed to assess stability and integrity of drug product formulations.
  • Lead the formulation and product development and stability assessment activities that may include pre-formulation activities, buffer/excipient screening and selection, developing lyophilized or freeze stable formulations.
  • Focus on stability testing and characterization of routes of degradation of LBP formulations in liquid and lyophilized formulations under accelerated temperature, refrigerated storage conditions and under different stresses in a variety of containers.
  • Communicate clearly, work independently, collaborate heavily, think critically
  • Perform troubleshooting activities, as needed
  • Proficient in DSC/mDSC and Freeze Dry Microscope method for the characterization of the frozen and dry formulation.
  • May conduct small-scale lyophilization experiments and/or direct production-scale, and lead and/or advise on technical transfer and scale up.
  • Identify formulations matrices that ensure the stability of targeted biological and the adjuvant molecules in liquid and lyophilized vaccines
  • Prepare technical reports, project monthly reports, PowerPoint presentations and other documentation reflecting the project(s) progress.


Experience and Skills

PHYSICAL DEMANDS
  • PhD in Pharmaceutical Sciences, Microbiology, Chemical Engineering, or related discipline with 0- 3 years of relevant experience or M.S. and 8+ years of relevant experience, or B.S. and 10+ years of relevant experience
  • 2 - 6 years of experience in lyophilization development, stability testing, and spray-drying technologies
  • Cycle design, excipient selection and buffer screening expertise is required. Prior experience in developing lyophilized LBPs or biologic formulation is preferred.
  • Working knowledge in Design of Experiments, QbD and statistical principles
  • Works collaboratively within group as well as within interdisciplinary teams
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills
  • Understanding of GMPs and regulatory expectations related to live biotherapeutic drug manufacturing processes is preferred
  • Previous mentoring, leadership, or management experience is preferred


BENEFITS

Arranta Bio is an Equal Opportunity Employer.