- Develop and optimize process parameters on particle formations such as: fractional flow rate, total flow rate and establish correlations.
- Develop and optimize tangential flow filtration process parameters, such as: loading capacity, flux rate, shear rate and transmembrane pressure (TMP).
- Compare and test new emerging technologies for the particle generation, such as microfluidics, tee mixing and jet mixing.
- Investigate and design the experiments using statistical analysis tools.
- Conduct comparability studies for excipients and buffers.
- Collaborate cross-functionally with other departments including process engineering, tech transfer, drug substance, and analytical development.
- Write, review, and approve scientific documentations (Batch records, SOPs, protocols, reports, etc.).
- Follow good laboratory practices and have GMP experience with Working knowledge of pharmaceutical/biotech processes.
- Follow Good documentation processes for both internal and client's work.
- Design & execute tech transfer that are complex and technically challenging.
- D. in pharmaceutical sciences or Engineering discipline with 3-5 years, or M.S. with 4-6 years experience in pharmaceutical industry with hands-on formulation/process development, and technology transfer to support LNP and other drug product manufacture.
- Heads on experience with formulation screening, process development, and process optimization.
- Heads on experience with technology transfer and/or scale up processing activities in process development.
- Experience with pharmaceutical unit operations including, but not limited to, LNP manufacturing via T-mixing, microfluidic mixing and/or impingement jet mixing, light scattering techniques, assay execution and development, tangential flow filtration.
- Experience with characterization instruments including, but not limited to dynamic light scattering, fragment analyzer/CE, bioanalyzer/gel electrophoresis, UV-spectroscopy, osmolality. HPLC and/or mass spectrometry are a plus.
- Experience with mixing studies, shear rate calculations, and scale-up
- Understanding of safe lab practices and BSL requirements.
- 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 required to travel occasionally, drive a motor vehicle.
- This position requires a criminal background check and drug screening.
- COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation.
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Scientist/Sr. Scientist, LNP Process Development - Watertown, United States - Arranta Bio
2 weeks ago
Description
ReciBioPharm, the biologics business unit of Recipharm AB, is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch. Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients. We partner with our clients to make treatments that can benefit vast patient populations, working across many indications. ReciBioPharm's mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives.
Job Description:
Arranta Bio is seeking a candidate with strong LNP and formulation process sciences experience. The Candidate The candidate will be working on developing, optimizing, and scaling up lipid nanoparticles formulations. The candidate will help with clients` tech transfer operations as well as support new process development proposals and initiatives for clients.
Responsibilities:
Education & Experience
Physical Demands
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.
Work Environment
This will be a lab and office-based position.
Who We Are
ReciBioPharm 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 ReciBioPharm, we embrace ALIVE – our core values that we live and breathe daily We are Agile, Leading, Innovating, Value Creating, and Engaging. Are you ready to come ALIVE with a daring and intrepid team? Don't wait another minute; Apply today
MEDICAL REQUIREMENTS
Benefits
ReciBioPharm offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
ReciBioPharm is an Equal Opportunity Employer.
