Temporary Process Development & Manufacturing Specialist II, CDMO

Posted Yesterday
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San Diego, CA, USA
In-Office
38-40 Hourly
Senior level
Biotech
The Role
Produces research and clinical-grade products through equipment operation, wet chemistry, purification, documentation, batch records, and SOP execution. Maintains equipment, troubleshoots processes, performs characterization assays, analyzes data, and implements process improvements. The role also transfers developmental improvements to manufacturing, authors procedures, and trains or mentors team members in laboratory and manufacturing processes.
Summary Generated by Built In

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 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 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/ 

To view more opportunities to become a #MiracleMaker, visit our career site at  https://www.maravai.com/careers/  

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. 

Click here to view Maravai LifeSciences Privacy Notice 


HIRING SCAM ALERT 

Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that: 

  • Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.) 
  • Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment. 
  • Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment. 

 If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at [email protected]. If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov. 

Skills Required

  • High school diploma or GED
  • Associate or bachelor's degree in science
  • 5+ years of industry experience
  • Hands-on laboratory experience with HPLC purification and/or small molecule synthesis
  • Experience working in a cGMP clean room
  • Experience with oligonucleotide synthesis and/or mRNA
  • Experience drafting, editing, implementing, and executing standard operating procedures
  • Strong written and verbal communication skills
  • Ability to organize and prioritize multiple tasks
  • Ability to mentor team members on proficient processes
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The Company
HQ: San Diego, CA
317 Employees
Year Founded: 1996

What We Do

TriLink’s CDMO services offer a range of manufacturing grade products from discovery-grade (RUO) to its customizable intermediate-grade - GMPLink™ to full GMP-grade with scale-up and technology transfer expertise. TriLink operates a quality system in compliance with ICH Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section 19, APIs for Use in Clinical Trials, and ISO 9001:2015 standards. TriLink continues to expand its cGMP and general mRNA, oligonucleotide & plasmid manufacturing capacity at its new global headquarters to support therapeutic, vaccine and diagnostic customers.

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