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

Employee Stock Purchase Plan

Medical + HSA/FSA

Fertility assistance

Pet insurance

Retirement contributions

Paid time off

Job summary

Maravai LifeSciences is seeking a Process Development & Manufacturing Specialist II to produce research and clinical grade components and to set up, clean, operate and maintain lab equipment. You will document actions in batch records and SOPs, mentor colleagues, and lead technical transfers for new equipment.

The role requires hands-on experience with HPLC purification, oligonucleotide/mRNA processes, and cGMP guidelines, with strong communication and organizational skills.

Qualifications

• High school diploma or GED required; higher science degrees preferred.
• 5+ years of industry experience.
• Hands-on lab experience in HPLC purification, small molecule synthesis, oligonucleotide synthesis, or mRNA.
• Experience drafting, editing, and executing Standard Operating Procedures.
• Strong written and verbal communication; ability to mentor others.

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.
• 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

HPLC purification

Small molecule synthesis

cGMP clean room

Oligonucleotide synthesis

mRNA

SOP drafting/editing

Written and verbal communication

Mentoring/training

Education

High school diploma or GED

Associate or Bachelor’s degree in science

Job description

Who we are:

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.

Who we are:

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 and equitableculture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, 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, andmaintainingequipment; performing wet chemistry reactions;utilizingpilot grade purification systems,authoringand 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,authorand review SOPs, andmaintainquality documents associated with manufacturing
• Keeps equipmentoperatingby 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 GEDrequired,Associate or Bachelor’sdegree 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,implementingand 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 part owner in Maravai through RSU grants and optional employee stock purchase plans.
• We offer comprehensive medical plans and HSA/FSA options.
• Fertility & family planning assistance.
• A variety of additional optional benefits and insurance options, including pet insurance.
• Retirement contributions.
• Holidays & Paid Time Off.

Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/

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 sexual orientation, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.