Scientist/Senior Scientist, Process Development and Manufacturing

Location
Menlo Park, CA, United States
Posted
Apr 14, 2021
Ref
30475
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
The Scientist/Senior Scientist, Process Development and Manufacturing is responsible for driving results in a fast-paced environment by leading the scale-up activities and refining the process.

Responsibilities

• Responsible for process research and development of various mRNAs.

o Evaluation of enzymes, plasmids and reagents to achieve required quality attributes of mRNA.

o Evaluation of process steps and parameters in IVT, capping and purification of mRNA to achieve higher yield and purity.

o Process research of novel approaches to produce mRNA

• Scale up mRNA production process from milligrams scale to grams scale and eventually to 100+ g scale.

• Set up GMP system for production of mRNA under development phase - appropriate cGMP.

• Manufacture GMP batches for toxicology and clinical studies as necessary.

• Perform mRNA testing as needed during process development and scale up.

• Work closely with Formulation, LNPs process R&D, analytical R&D, quality and regulatory teams.

Qualifications

• BS/MS with 6 to 8 years relevant experience (PhD with 2 to 5 years preferred) in making purifying and analyzing oligonucleotides, mRNAs at bench and larger scales.

• Strong foundation in biochemistry, molecular biology, or related field.

• Familiarity with cGMP requirement for early development is a plus.

• Must be comfortable in a fast-paced small company environment with minimal direction.

• Flexible, adapt to change, and work independently and as part of a multi-disciplinary team.

• Self-starter with excellent interpersonal skills with demonstrated success in working collaboratively cross functionally in a matrix environment.

• Multi-task, pay attention to details and produce high quality work under tight timelines.

• Strong oral and written communication skills to support internal and external communications/presentations.

• Prior experience leading teams preferred.