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Sr. Manufacturing Associate I, Fill Finish

Company

Moderna Therapeutics

Address , Norwood, 02062, Ma
Employment type
Salary
Expires 2023-06-10
Posted at 1 year ago
Job Description
The Role:
A Sr Manufacturing Associate I, in the Fill Finish Operations, Drug Product group is responsible for final sterile filtration, vial filling, visual inspection, label and packaging (Fill Finish) of Moderna’s mRNA Drug Products. This position is located at Moderna’s GMP Manufacturing site in Norwood, MA. This role will be a 1st shift Sunday to Wednesday 7:00AM to 5:00PM.
The individual in this role will be part of a cohesive team responsible for supporting GMP mRNA-based medicines for evaluation in human clinical trials through execution of sterile filtration, vial filling, visual inspection, and labeling and packaging activities. The successful candidate will be able to document all activities performed following cGMP guidelines and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Manufacturing Sciences and Technology, Quality Control, Quality Assurance, Logistics and Process Development Technology Transfer counterparts.
Here’s What You’ll Do:
Acts as a lead/participates/checks on the work of others in executing sterile filtration, filling, visual inspection, labeling, and packaging using disposable technologies, automation, and Manufacturing Execution Systems (MES).
Demonstrates advanced applicable and specific knowledge of standard manufacturing practices and equipment.
Acts as a lead/participates/checks on the work of others in fill finish activities for multiple drug product vial types and packaging configurations.
Recognized as a mentor and trainer to others and strives to make the team better.
Collaborate with Supply Chain, maintain inventory and review process orders.
Closely partner with QA and QC peers for execution of fill finish activities.
Responds rapidly and trouble-shoots routine equipment process and digital issues.
Maintain individual training compliance as well as train others in the manufacturing process.
Works autonomously within current good manufacturing practices, standard operating procedures, and manufacturing documentation.
Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
Opens and investigates deviations in coordination with other functions.
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
Lead/participate in multiple projects in a fast-paced environment and drive for continuous improvement.
Effectively collaborate in a dynamic, cross-functional matrix environment.
Adhere to and reinforce gowning procedures and maintain a clean general operating area.
Flexibility to work off hours and overtime if needed and ability to identify and fill workflow gaps to meet clinic demand and process schedules.
Here’s What You’ll Bring to the Table:
Associates Degree / Biotechnology Certificate / Bachelor of Science with cGMP plus 5-7 years’ experience.
Ambitious and self-starting attitude to take on responsibilities and own process improvements.
Experience in electronic batch records, Syncade, OSI PI, eDMS, and SAP preferred.
Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP.
Express Moderna’s core values: Bold – Curios – Relentless – Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:
  • D iscretionary year-end shutdown
  • Volunteer time to participate within your community
  • Vacation, sick time and holidays
  • Paid sabbatical after 5 years; every 3 years thereafter
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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