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