Principal Scientist Oral Drug Product Formulation & Process Development

Employer
Arranta Bio
Location
Gainesville, FL, United States
Posted
Oct 27, 2020
Ref
85503-312550
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 Principal Scientist of Formulation & Drug Product Development will be responsible for the end-to-end Drug Product Development of Live Biotherapeutic Products (LBPs).

Work closely with the Drug Substance, Analytical, Quality Control, Process Development, Drug Product Manufacturing and Quality Assurance teams to facilitate the development of robust, scalable and reproducible formulations and processes for LBPs.

ESSENTIAL RESPONSIBILITIES
  • Formulation development and optimization, process development and optimization, scale-up, technology transfer of Live Biotherapeutic Products (LBPs).
  • Independently design and perform hands-on experiments on oral solid dosage unit operations, including, but not limited to, blending, roller compaction, encapsulation, banding, coating, and packaging.
  • Design and perform experiments using DOE, statistical tools for data analysis and principles of Quality-by-Design for Drug Product Development.
  • Design development stability strategies, including selection and technical justification for packaging materials.
  • Familiarity with the role that physicochemical properties play in drug delivery and formulation design.
  • Pursue and ensure superior stability and manufacturing feasibility.
  • Design and conduct formulation studies at various stages of development to provide data to support early phase clinical trial, such as stability, solubility and effects of pH.
  • Train and mentor junior level scientists, as needed.
  • Support GMP manufacturing, packaging, and/or labeling operations, as needed.
  • Understand and practice good documentation practices. Document all work in laboratory notebook(s) or other acceptable forms (e.g., batch records).
  • Write and review SOPs, development protocols, and technical reports.
  • Assist with troubleshooting, deviations, and investigations, as requested.
  • Contribute to preparation and review of regulatory documents for submission to FDA and other regulatory authorities.
  • Lead or contribute to invention disclosures and patentable advancements.


Experience and Skills

EDUCATION AND/ OR EXPERIENCE
  • Ph.D. in Pharmaceutics or related discipline with 5+ years of relevant experience. Non-Ph.D. candidates with 10+ years of relevant experience will be considered. Key relevant experience should include hands-on formulation and process laboratory experience to support solid oral dosage forms.
  • Hands-on experience with pharmaceutical unit operations, equipment and instrumentation to support formulation activities for solid oral dosage forms.
  • Hands-on experience in independently running small-scale processing equipment for solid oral dosage forms is very important for this role.
  • Understanding and incorporation of DOE, statistical data analysis and QBD into product development will be a huge plus.
  • Demonstrated ability to write technical reports and other technical documentation (e.g., protocols, SOPs, etc.).
  • Understand and implement FDA and ICH requirements into Product Development (e.g., Quality-by-Design) for IND, CTA, IMPD and Quality submissions.
  • Knowledge of pharmaceutical GLPs and GMPs, especially as related to solid oral dosage form manufacturing.
  • Motivated self-starter who can work independently with minimal supervision.
  • Excellent professional, interpersonal skills and communication skills.
  • Ability to work hands-on efficiently and cooperatively in a small laboratory environment.
  • Goal oriented and ability to deliver on timelines and commitments.
  • Exhibits a proactive, transparent, and rigorously objective confidence in all aspects of work activities.