Principal Scientist Oral Drug Product Formulation & Process Development, Microbiome
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!
The Principal Scientist of Formulation & Drug Product Development will be responsible for the end-to-end Drug Product Development of Live Biotherapeutic Products (LBPs). Works 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 JOB FUNCTIONS
- 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, tableting 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.
- Characterize Drug Substance: Isotherm analysis, particle sizing, bulk/tapped density, DSC studies etc.
- Evaluate and develop formulations for alternate drying technologies (electrostatic spray dry, fluid bed dry, freeze dry etc)
- Design and develop formulations for pediatrics
- 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.
- Ensure development of technologies and scientific innovation that improve the capability to formulation live biotherapeutics
Experience and Skills
- Ph.D. in Pharmaceutics or related discipline with 10+ years of relevant experience. Non-Ph.D. candidates with 15+ 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.
- Experience in physico-chemical characterization of live biotherapeutics.
- Experience in the characterization and formulation of live biotherapeutics.
- Experience in the characterization of amorphous solids, especially the dynamics of amorphous solids and crystallization behavior
- Experience with analytical approaches toward physicochemical characterization of pharmaceutical dosage forms (i.e. HPLC, DSC, TGA, PXRD, dissolution, etc.).
- Fundamental understanding of physicochemical properties as related to formulation design.
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.
- 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
- Phone reimbursement policy for qualified individuals
- Free parking
- Highly competitive healthcare with many plan options:
- Medical (HMO/PPO/EPO)
- 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)