MCS Manufacturing Sr. Associate

1 month ago

Thousand Oaks, United States BioPharma Consulting JAD Group Full time
Job DescriptionJob Description

Summary: At BioPharma Consulting JAD Group, we are seeking a motivated MCS Manufacturing Sr. Associate to join our Team. As a Senior Associate, you will be responsible for supporting manufacturing operations and leading continuous improvement initiatives. You will collaborate with cross-functional teams to ensure quality, safety, and compliance in all manufacturing processes.

Responsibilities:

  • Under minimal supervision, performs manufacturing according to Standard Operating Procedure
  • Understand process parameters and can identify process anomalies
  • Operate critical processing equipment
  • Assist in ensuring operations are completed per manufacturing schedule
  • Resource related to processing operations on the mfg. floor
  • Responsible for identifying and communicating problems during operations
  • Review, revise, and audit documents
  • Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
  • Recognizes and escalates problems
  • Able to establish working relationships with others outside area of expertise
  • Ability and willingness to support flexible shift structure in support of operations (may include weekend)
  • Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position
  • Organizational skills and an ability to perform assignments with a high degree of attention to detail
  • Written and oral communication skills.
  • GMP knowledge with ability to interpret and apply applicable regulations.
  • Ability to understand analytical methods for manufacturing/laboratory area.

Preferred Qualifications:

  • Technical knowledge of drug substance processing and a broad understanding of related disciplines.
  • Excellent communication skills, both written and oral, with the ability to present complex technical information to various organizational levels.
  • Ability to coach, mentor, and cross-train colleagues.
  • Strong team player with the ability to support and reprioritize tasks as needed.
  • Proven leadership skills in managing cross-functional teams and driving project results.
  • Proficiency in Smartsheet, Excel, Trackwise, Visio, PI, SAP, and Spotfire.

Requirements

Qualifications:

  • Bachelor’s degree in Engineering or Life Sciences and 1 years of experience OR
  • Associate’s degree and 2 years of experience OR
  • High school diploma/GED and 4 years of experience

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