Temporary Process Development & Manufacturing Specialist II, CDMO

Maravai-Lifesciences; San Diego (CA); On-site; USD 52,000 - 55,000; Full time

Benefits offered by this job

Medical plans with HSA/FSA options

RSU grants

Employee stock purchase plan

Fertility & family planning assistance

Pet insurance

Job summary

Maravai LifeSciences is seeking a Temporary Process Development & Manufacturing Specialist II to join our lab team in San Diego, onsite. You will produce research and clinical grade components, set up and operate equipment, perform wet chemistry, and document actions in batch records following Good Documentation Practices, mentoring junior staff.

You should have 5+ years of industry experience, strong lab background (HPLC purification, oligonucleotide/mRNA), and experience drafting SOPs.

Qualifications

• High school diploma or GED required; Associate or Bachelor’s degree preferred (Science)
• 5+ years of industry experience
• Hands on laboratory experience in 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

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
• Perform other functions and duties as required

Skills

Industry experience

SOP drafting

Mentoring

Strong communication

Multi-tasking

Lab organization

Education

High school diploma or GED

Associate or Bachelor's degree

Tools

HPLC purification

Oligonucleotide synthesis

Small molecule synthesis

cGMP clean room

Pilot purification systems

Job description

Temporary 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 Temporary Process Development & Manufacturing Specialist II . As a Temporary 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 hourly rate for this position is $38 - $40 per hour. The 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.

#LI-Onsite

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.

MaravaiLifeSciences 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

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.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A \"recently separated veteran\" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.