Manufacturing Formulation Supervisor

SHARP STERILE MANUFACTURING LLC•Lee, MA

44d

About The Position

The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel.

Requirements

Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products
Two (2) to three (3) years' work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of same
Leadership experience as a team lead of supervisor type role preferred
Bachelor's degree preferred
An equivalent combination of education and experience may be considered
Possess working knowledge of formulation/compounding processes and equipment
cGMP and cGLP practices
Experience with Microsoft Office and general computer proficiency
Attention to detail
Able to follow rules and regulations
Mechanical aptitude
Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
Honesty, integrity, respect and courtesy with leadership and peers
Ability to build collaborative relationships
Supervisory skills
Conflict resolution
Able to perform complex work instructions and trouble shoot complex problems
Able to meet gowning requirements
Visual acuity
Fine and gross motor skills to manipulate tools and equipment
Able to remain stationary for continuous prolonged periods of time
Able to lift 30lbs repeatedly
Able to wear PPE
Able to be medically qualified to participate in respirator program
Able to use standard office equipment with or without reasonable accommodation

Nice To Haves

Leadership experience as a team lead of supervisor type role preferred

Responsibilities

Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completed
Responsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss
Maintain weekly/daily schedule
Use production schedule and activities, communicate necessary to do tasks to associates and/or leads
Communicate and maintain the thaw / equilibration schedules for chemicals and/or equipment
Maintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as needed
Review Master Production Batch records in timely manner and provides suggestions/corrections to PE member
Review SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframes
Complete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for review
Initiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions
Identify safety risks and alerts management to take corrective action
Provide timely communication to management and clients of issues, challenges as well as opportunities for process improvements
Other duties as assigned
Ensure all work is conducted following a high standard of GMP compliance and written SOP and batch records
Comply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirements
Assign and direct work, provide direction, resources and resolve problems
Participate in recruiting
Provide feedback on performance to Formulation Manager
Train team members and ensures proper training is completed prior to assigning tasks