Process Development & Manufacturing Specialist I (Biotech)

Alphazyme, LLC

Florida

Sur place

USD 70 000 - 90 000

Plein temps

14 jours+

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Avantages offerts par ce poste

RSU grants
Employee stock purchase
Medical plans
Fertility benefits
Pet insurance
Retirement contributions
Paid time off

Résumé du poste

Alphazyme, a Maravai LifeSciences company, is seeking a Process Development & Manufacturing Specialist I to join our Manufacturing team in New York. The role supports enzyme production and process development by executing established lab and manufacturing protocols, contributing to product manufacturing, process characterization, and production readiness while ensuring quality and safety standards.

Under supervision, you will help scale processes, document activities in batch records, and

Qualifications

  • High school diploma with 2+ years of industry experience or degree in Biochemistry/Biology preferred.
  • Hands-on experience with enzyme production/manufacturing processes such as fermentation, filtration, chromatography, or enzymatic reactions preferred.
  • Basic understanding of GMP, ISO, or regulated manufacturing environments and documentation practices (GDP).
  • Ability to follow SOPs and execute protocols with attention to detail and data accuracy.

Responsabilités

  • Execute enzyme production and manufacturing processes following established protocols.
  • Prepare materials, equipment, and production areas for scheduled operations.
  • Accurately document production and experimental activities in batch records per GDP.
  • Operate and maintain lab and manufacturing equipment, performing basic troubleshooting and routine maintenance.
  • Support process characterization and development activities under supervision to improve product quality.
  • Collaborate with Manufacturing, Quality, and Supply Chain to support production schedules and material flow.
  • Maintain compliance with cGMP, ISO standards, and safety requirements.
  • Perform other duties to support production and process development objectives.

Connaissances

Attention to detail
Data accuracy
Communication
Teamwork
Problem solving
Microsoft Office

Formation

Bachelor’s degree in Biochemistry or related

Outils

ERP systems
Document control systems
Microsoft Office

Description du poste

Process Development & Manufacturing Specialist I

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 equitable culture 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 Manufacturing team as a Process Development & Manufacturing Specialist I . Th eProcess Development & Manufacturing Specialist Isupports enzyme production and process development activities by executing established laboratory and manufacturing protocols. This role contributes to product manufacturing, process characterization, and production readiness while ensuring compliance with quality and safety standards. The Specialist I works under supervision to support process scalability, documentation, and continuous improvement initiatives within Alphazyme’s manufacturing operations.

How you will make an impact:

  • Execute enzyme production and manufacturing processes, including fermentation, enzymatic reactions, filtration, and chromatography, following established protocols.
  • Prepare materials, equipment, and production areas to support manufacturing activities and ensure readiness for scheduled operations.
  • Accurately document production and experimental activities in batch records, logs, and reports in accordance with Good Documentation Practices (GDP).
  • Operate and maintain laboratory and manufacturing equipment, performing basic troubleshooting and routine maintenance.
  • Support process characterization and development activities under supervision to improve product quality and consistency.
  • Collaborate with Manufacturing, Quality, and Supply Chain teams to support production schedules and material flow.
  • Maintain compliance with cGMP (as applicable), ISO standards, and safety requirements.
  • Perform other duties as assigned to support production and process development objectives.

The skills and experience that you will bring:

  • High school diploma with 2+ years of relevant industry experience, or Associate’s/Bachelor’s degree in Biochemistry, Biology, or related scientific discipline preferred.
  • Hands-on experience or exposure to enzyme production/manufacturing processes such as fermentation, filtration, chromatography, or enzymatic reactions preferred.
  • Basic understanding of GMP, ISO, or regulated manufacturing environments and documentation practices (GDP).
  • Ability to follow SOPs and execute protocols with attention to detail and data accuracy.
  • Strong organizational and problem-solving skills with the ability to manage multiple tasks in a dynamic environment.
  • Effective communication and teamwork skills; proficiency with Microsoft Office and familiarity with ERP or document control systems is a plus.

#LI-Onsite

The benefits of being a #Mirac le Maker:

  • You have the potential to change, improve , and save lives around the world.
  • You have the opportunity to be a part o wner in Maravai through RSU grants and optional employee stock purchase plans .
  • We offer comprehensive medical plans and H SA /FSA options .
  • Fertility & family planning assistance .
  • A variety of additional optional benefit s 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/

Alphazyme, a Maravai LifeSciences company, 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.

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 taops@maravai.com . If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov .

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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 Alphazyme’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.

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