The Manufacturing Associate I-III (Flex) will perform daily cGMP manufacturing activities with a strong emphasis on plasmid, xRNA, LNP, Fill-Finish platform processes. Responsibilities may include media/buffer production, upstream culturing, downstream purification, and drug product (DP) processing, alongside ensuring general suite/operational readiness.

The position requires adaptability to work both first and second shifts based on business needs.

Primary: Monday through Friday, First Shift: 7:00 AM – 3:30 PM

Secondary (as required): Monday through Friday, Second Shift: 3:00 PM – 11:30 PM

The specific job title (Associate I, II, or III) and compensation will be determined based on the candidate's experience and qualifications.

Essential Duties & Responsibilities

  • Preparation of media and buffers for manufacturing processes.
  • Execution of GMP activities in cell culturing, fermenter operations, harvest/clarification, purification or plasmid RNA, and Lipid Nanoparticle (LNP) drug product production within a cGMP environment.
  • Follow verbal and written procedures to operate production equipment and perform processing steps. Complete appropriate production documentation accurately.
  • Documentation of all activities in Batch Records, Logbooks, Forms, etc. and electronic interfaces
  • Maintain the highest standards of workplace Safety and product quality
  • Identify, escalate, and documents events, deviations and variances from normal operations; participate in investigations and needed.
  • Demonstrates ability to troubleshoot basic mechanical operations.
  • Work in accordance with site and company Environmental, Health, and Safety (EHS) programs.
  • Adhere to regulations, detailed protocols, Batch Records, SOPs and Work Instructions.
  • Strong commitment to continuous improvement

Qualifications

Education/Experience

  • High School Diploma / Technical Degree OR
  • B.S. in Biology, Biochemistry, Chemical Engineering, or a related field preferred.
  • Prior experience in plasmid DNA, RNA, lipid nanoparticle (LNP) formulation, and/or visual inspection in GMP highly desirable.
  • Experience in Operational Excellence methodologies, such as 6S, are a plus.
  • Working knowledge of Microsoft Outlook, Word and Excel required.
  • Good laboratory skills and excellent record-keeping, including GDP, is required.
  • Ability to work independently and stay on task in a fast-paced environment without direct supervision.
  • Strong collaboration skills and ability to work effectively in a team-oriented environment.
  • Regular and reliable performance and attendance required.
  • Able to work in a rapidly changing environment and the ability to react well to change.
  • Ability to handle multiple tasks while remaining focused.
  • Reliable, dependable, and organized.

Language, Mathematical, Reasoning Ability

  • Detail-oriented, excellent written and verbal communication skills required.
  • Mechanical / Analytical skills.
  • Basic Math skills.
  • Ability to understand written or verbal instructions (in English) and execute accurately and independently

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Flexibility in Work Hours: This position requires adaptability to varying shift schedules, with a primary shift from 7:00 AM-3:30 PM and a secondary shift from 3:00 PM-11:30 PM, based on business needs.
  • Physical Activities: While performing the duties of this job, the employee is regularly required to: stand for extended periods; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk or hear; and lift/move up to 10 pounds.
  • Occasional Physical Activities: The employee is occasionally required to: walk; climb or balance; stoop, kneel, crouch, or crawl; and lift/move up to 25 pounds.
  • Vision Requirements: Near-vision performance of 20/20 or better (natural or corrected) and no color vision impairment.
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