Scientist Lyophilization

Employer
Arranta Bio
Location
Gainesville, FL
Posted
Jul 22, 2021
Ref
85503-325782
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

 The Scientist will lead activities related to lyophilization development. Staying up to date with best practices and advancements in research is anticipated and should result in creative and inspiring suggestions for alternative methodology and processes. He/She will lead in solving complex problems by applying current best technical practices and be able to connect cross-functionally to leverage methodologies used in other fields as well as own. The Scientist will demonstrate a sense of urgency in the work while maintaining respect for best practices and an understanding for the importance and applicability of quality and controls in development activities. The problem solving, data analysis and interpretation will be focused, data driven and result in thorough documentation and pointed technical reports suitable for executive management. The Scientist will be well versed in internal and external best practices, lead internal and external projects, and be the research expert in interactions with company colleagues. It is expected he/she will continuously improve operational effectiveness and participate actively in the recruitment of technical staff to maintain an effective level of technical ability for all business requirements.

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

· B.S. or M.S. degree in Bio-process Engineering or Bioscience, or related field with 8+ years of industry experience

· Or a PhD degree in life sciences with 1+ years of relevant industry experience

· 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

 

PHYSICAL DEMANDS

· While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.

· The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.

· The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

· Specific vision abilities required by this job include close vision, and ability to adjust focus.

· In the performance of the duties of this job the employee is not required to trave

l · The employee will be required to communicate using telephone and e-mail.

BENEFITS

  • Phone reimbursement policy for qualified individuals
  • Free parking
  • Highly competitive healthcare with many plan options:
  • Medical (HMO/PPO/EPO)
    • Dental
    • vision
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Up to 10 weeks of 100% paid maternity leave
  • 2 weeks of 100% paid paternity, domestic partner, & adoption leave
  • Educational assistance program
  • 401k (traditional and Roth offered) with 100% match on first 5% deferred.
  • A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • Employee Referral program
  • Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)