Process Development & Manufacturing Specialist II, CDMO

Maravai-Lifesciences; San Diego (CA); On-site; USD 80,000 - 85,000; Full time

Benefits offered by this job

RSU grants and stock purchase plan

Comprehensive medical plans

HSA/FSA options

Fertility & family planning assistance

Pet insurance

Job summary

Maravai LifeSciences is seeking a Process Development & Manufacturing Specialist II in San Diego to produce research and clinical grade components and products. You will set up, clean, operate, and maintain equipment; perform wet chemistry reactions; utilize pilot purification systems; author SOPs; and document actions with Good Documentation Practices.

Lead and mentor lab colleagues. The role requires hands-on lab experience (HPLC purification, oligonucleotide/mRNA), cGMP environment

Qualifications

• Hands-on laboratory experience in HPLC purification and/or small molecule synthesis.
• Experience drafting, editing, implementing and executing Standard Operating Procedures.
• Strong written and verbal communication skills.
• Ability to mentor other team members on processes they have become proficient at executing.

Responsibilities

• Produces research and clinical grade components and products.
• Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling materials and supplies.
• Maintains safe and clean work environment by following standard operating procedures.
• Writes and executes batch records, author and review SOPs, and maintain quality documents associated with manufacturing.
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling all repairs.
• Documents production by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices.
• Trains and mentors new team members.
• Onboards and authors procedures for new equipment.
• May collect, records and analyze data.
• Interprets key process bottlenecks and implements process improvements to minimize bottleneck.
• Performs characterization assays centered around developmental improvements.
• Transfers developmental improvements to manufacturing team through training/technical transfer.

Skills

HPLC purification

Oligonucleotide synthesis

cGMP clean room

mRNA

SOP drafting

Mentoring

Education

High school diploma or GED

Associate or Bachelor’s degree preferred

Job description

Process Development & Manufacturing Specialist II, CDMO

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.

At Maravai, we believe that diverse perspectives are the foundation of innovation.Through an inclusive andequitableculture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together,providingdifferentiated value to our customers, and enabling the miracles of science.For over 35 years,Maravai’sportfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since itsinception, we are now leading the way in the rapidly expanding mRNA market.

Your next role as a Miracle Maker

Maravai LifeSciences is seeking a #MiracleMaker to join our customer development team as a Process Development & Manufacturing Specialist II . As a Process Development & Manufacturing Specialist II, you will produce research and clinical grade components and products by setting up, cleaning, operating , and maintaining equipment; performing wet chemistry reactions; utilizing pilot grade purification systems, authoring and implementing SOPs, and documenting actions in batch records. Must document all actions using Good Documentation Practices. This role is the subject matter expert and provides leadership/mentoring/training in the laboratory.

How you will make an impact:

• Produces research and clinical grade components and products
• Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling materials and supplies
• Maintains safe and clean work environment by following standard operating procedures
• Writes and executes batch records, author and review SOPs, and maintain quality documents associated with manufacturing
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling all repairs
• Documents production by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices
• Trains and mentors new team members
• Onboards and authors procedures for new equipment
• May collect, records and analyze data
• Interprets key process bottlenecks and implements process improvements to minimize bottleneck
• Performs characterization assays centered around developmental improvements
• Transfers developmental improvements to manufacturing team through training/technical transfer
• Perform other functions and duties as required

The skills and experience that you will bring:

• High school diploma or GED required , Associate or Bachelor’s degree preferred (Science)
• 5+ years of industry experience
• Hands on laboratory experience in areas such as HPLC purification and/or small molecule synthesis, cGMP clean room, oligonucleotide synthesis, mRNA
• Experience with drafting, editing, implementing and executing Standard Operating Procedures
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to mentor other team members on processes they have become proficient at executing

The anticipated salary range for this position is $80,000 - $85,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.

The benefits of being a #MiracleMaker:

• You have the potential to change,improve, and save lives around the world.
• You have the opportunity to be a partowner inMaravai through RSU grants andoptionalemployee stock purchase plans.
• Weoffer comprehensivemedical plansandHSA/FSAoptions.
• Fertility &family planningassistance.
• A variety ofadditionaloptional benefitsand insurance options, includingpet insurance.

Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexualorientation,and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

As set forth in Maravai LifeSciences’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.