Scientist/Senior Scientist, Process Development and Manufacturing

Location
Menlo Park, CA, United States
Posted
Nov 17, 2020
Ref
30475
Hotbed
Biotech Bay
Required Education
Bachelors Degree
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.