Lean Manufacturing Manager jobs in Pittsfield, MA

Position Summary

The Formulation Manufacturing Manager is a hands-on role overseeing technical transfer and the routine manufacturing of bulk formulated drug products who is a subject matter expert in all cGMP activities and manufacturing floor operations.  This individual owns department operations, ensuring manufacturing of products meet deadlines and specifications.

Duties and Responsibilities

• Manage formulated drug product cGMP manufacturing including buffer preparation, bulk formulation and aseptic filtration
• Produce GMP clinical and commercial material on-time, according to the manufacturing timelines and demand plan
• Ensure the successful technical transfer of projects in partnership with the Process Engineering group including review and approval of Master Batch Records and training of formulation associates
• Work closely with the production staff to troubleshoot process and equipment problems
• Ensure appropriate and proactive client and internal stakeholder communication
• Create, revise, and edit MBR’s and SOP’s as needed
• Mange the timely review and approval of all in-process and completed Formulation Master Batch records in accordance with product release schedule
• Drive enhancements necessary to improve capacity utilization and avoid capital expenditures 
• Monitor and report equipment operational status
• Recommend equipment changes, upgrades and additions
• Interface with supply chain, engineering, quality. project management and maintenance personnel to accomplish department performance objectives
• Prepare and publish weekly departmental metrics
• Participate in internal audits as applicable
• Attend and complete all mandatory training 
• Travel periodically to customers, vendors or training as needed
• Other duties as assigned

Regulatory Responsibilities  

• Ensure work is performed in compliance with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's) and Health and Safety requirements

Supervisory Responsibilities

• Provide leadership in daily operations and have employees incorporate compliance practices into their daily routines
• Oversee and participate in the recruitment and selection and successful onboarding of department staff
• Provide direct reports with ongoing performance feedback and develop a positive work environment for all employees
• Coordinate training and competency validation for department staff
• Ensure staff attend technical and mandatory training/education

Experience

• At least three (3) years leading downstream purification or formulated drug product manufacturing operations for aseptic formulations, four (4) to seven (7) years’ experience preferred
• Strong background in manufacturing operations and GMP quality systems and understanding of process development

Education

• Bachelor's or Master’s degree in a related scientific field 
• An equivalent combination of education and experience may be considered

Knowledge, Skills & Abilities

• Able to transfer purification/drug product formulation process from process Engineering into Manufacturing
• Able to write technical manufacturing batch records and procedural SOP’s
• Able to support regulatory inspections and audit readiness activities
• Able to apply continuous improvement strategies 

Physical Requirements 

• Ability to meet gowning requirements for cleanroom activities 
• Lift up to approximately 15-30 pounds frequently and up to 50 lbs. occasionally
• Frequent standing and walking throughout the facility
• Use of both hands and arms in repetitive motion
• Fine and gross motor skills 
• Satisfactory audio-visual acuity