III - Commercial

Genezen•Lexington, MA

9h•$65,000 - $105,000•Onsite

About The Position

The Manufacturing Operations Support Specialist - Commercial will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The Specialist works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion. This position is located in Lexington, MA. The level of this position will be determined based on the selected candidate's qualifications, skills, and relevant experience.

Requirements

BS or MS degree in biology, biochemistry, molecular biology, or related field, or equivalent experience
Minimum 1-8+ years related industry experience in related field
Experience with owning, investigation and writing deviations, creating and executing CAPAs, and writing and managing Change controls
Experience in biomanufacturing unit operations (USP and/or DSP)
Experience performing root cause analysis using practices, such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and the basic Quality Improvement Tools (e.g., Pareto Chart, Control Chart, and Process Map, etc.)
Able to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures
Ability to apply systems thinking as part of a problem-solving
Demonstrates industrial empathy when working with stakeholders
Detail oriented and able to self-organize
Able to communicate in a professional way on diverse levels and channels
Takes the initiative to own and resolve issues
Good technical writing and oral communication skills

Responsibilities

Practices and promotes safe work habits and adheres to safety procedures and guidelines
Utilizes manufacturing process knowledge and investigation skill to identify and resolve manufacturing issues, improve process operations and affect positive change.
Performs root cause analysis on Manufacturing quality events and leads investigations for minor and major quality events.
Identifies and drives Manufacturing corrective and/or preventative actions.
Provide Manufacturing support for tech transfers
Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on changes impacting manufacturing.
Participates on cross functional teams to drive complex manufacturing operations changes or improvements
Supports document revisions and/or document management including batch production records and manufacturing procedures
Performs training with staff on the floor
Provides expertise for processing technology (chromatography, filtrations, digital systems, etc…)
Participates in cross-functional equipment and operational process improvement while teaming with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant manufacturing documentation.
Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion, with periodic management guidance
Reviews the work of others and provides feedback
Creates and presents trending and metrics reports
Participates in equipment start-up, commissioning, and validation activities
Works in a manner that requires consistent exercise of discretion and judgment