Senior/Principal Scientist, RNA PD

Recipharm; Stockholms kommun; Sur place; USD 145 000 - 155 000; Plein temps

Résumé du poste

Recipharm is seeking a scientific leader to guide RNA process development across IVT and downstream operations, enabling scale-up, tech transfer, and GMP manufacturing support. The role focuses on designing, executing, and interpreting critical experiments for RNA modalities such as mRNA, saRNA, siRNA, and circRNA.

As a leader in the RNA process science group, you will mentor scientists, drive cross-functional collaborations with analytics, tech transfer, and manufacturing, and contribute to

Qualifications

• Extensive hands-on experience in production of RNA modalities (mRNA/saRNA/siRNA/circRNA).
• Deep knowledge of IVT reaction optimization and mRNA downstream unit operations.
• Experience with DOE is a plus.
• Experience with large-scale bio-manufacture and cGMP is a plus.
• Ability to independently design experiments and analyze complex data.

Responsabilités

• Lead scientific/laboratory activities within RNA process science team.
• Act as SME in RNA process to drive development, tech transfer and scale-up.
• Assist plasmid downstream process development using chromatography and filtration.
• Design and execute complex experiments for troubleshooting and method development.
• Collaborate with analytics, tech transfer, GMP manufacturing and Quality.

Connaissances

RNA process development

DOE design

cGMP

Scale-up manufacturing

Data analysis

Outils

Chromatography

Filtration

Description du poste

This position reports to the Head of Technical Operations and plays a key role in leading laboratory /experimental approaches for optimized RNA production. They will lead the efforts to design, execute, and interpret critical experiments for the success of various RNA modalities in activities including IVT high throughput screening, downstream development, process scale-up and tech transfer. This role will also support downstream process development for plasmid purification and related analytical development for in-process monitor and final product release. The individual will work collaboratively in a cross‑functional environment including analytics, tech transfer, GMP manufacturing and Quality. The successful candidate has a big potential to grow as a leader in nucleic acid process science group.

• Serve as a scientific/laboratory leader to guide & mentor scientists and associates within RNA process science team
• Serve as a Subject Matter Expert in RNA process to lead RNA process development activities in a combination of customer related, and internal related projects. These may include technology transfer, technology establishment, scale up manufacturing, process optimization, platform development.
• Assist in plasmid downstream process development using related chromatography and filtration technologies.
• Design & execute complex and technically challenging experiments for trouble shooting and method development.
• Support leadership team to evaluate new technologies and lead internal/external technical collaborations.
• Evaluate functional strengths and identify developmental areas with the ability to focus on continuous improvement
• Represent plasmid process development in cross‑functional team forums including GMP manufacturing/non‑GMP manufacturing, interdepartmental meetings, etc.
• Lead presentation, publication and/or patenting of findings or is a major contributor to these processes.

Experience And Skills

• Experts with extensive hands‑on experience in production of mRNA, saRNA, siRNA, circRNA, and/or other RNA modalities.
• Extensive hands‑on experience in process characterization and common RNA analytics.
• Deep knowledge in IVT reaction optimization and mRNA downstream unit operations.
• Experience with statistical design of experiments (DOE) is a plus.
• Experience with commercial scale up, large‑scale bio‑manufacture and cGMP is a plus.
• Ability to independently design experiments, analyze complex data and interpret and present experimental results, required.

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.

• 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 travel
• The employee will be required to communicate using telephone and e‑mail.

Annual Base Salary Range from $145,000 to $155,000

Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 4,500 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre‑clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live‑microbial biopharmaceutical products, nucleic acid‑based mRNA and plasmid DNA production. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden. For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com