SD/SEV & Aseptic Finished Goods Manager

Job description:

General Requirements

This position will require the employee to fulfill the following general requirements for employment at Stallergenes Greer and includes but limited to:

• Practice good hygiene and personal sanitation practices
• Compliance with applicable standard operating procedures
• Compliance with company environmental health and safety procedures
• Protect and preserve Stallergenes Greer physical property and equipment
• Protect and preserve Stallergenes Greer intellectual property and confidential information

Education Requirements

This position requires the following minimum education:

• Bachelor’s Degree

Work Experience Requirements

• 8-10 years of experience and/or training in Finished Goods operations.
• Technical Writing
• Problem Solving
• Leading/Coaching Individuals in a Team
• 4 years’ experience leading 1 or more departments within the biopharma or pharmaceutical industry in a production environment – Multi Departmental experience a plus
• Ability to create metrics and KPI’s to measure efficiency and throughput

Specific Job Requirements

This position requires the following for employment at Stallergenes Greer and includes but not limited to:

Job Task(s)

• Manage the daily manufacturing activities of the sterile filling operations for Allergy extracts and SD/SEV
• Coordinate scheduling of routine activities and tasks to personnel to effectively meet production timelines.
• Ensure batch documentation is completed according to appropriate GMP standards.
• Check inventory and orders supplies as necessary based on schedule.
• Communication of issues within Department and with Cross Functional Departments.
• Ability to present metrics within Department and with Cross Functional Departments including Senior Leadership.
• Effectively communicate schedule or process changes to affected personnel in a timely manner.
• Investigation of Events, Deviations, Out of Specifications, etc…
• Implement process improvements through Lean Six Sigma tools, 6S, CAPA, Change Controls, etc…
• Complete Change Requests and revision of documents
• Keep track of technician’s training/qualifications to ensure they are up to date
• Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements
• Interviews, hires, coaches, motivates, develops, recognizes and manages performance of direct reports
• Assign performance objectives and development plans, monitor progress and provide regular feedback to all direct reports
• Other Job Duties as Assigned

Physical Demand(s)

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Requires Type 2 Garb qualification (Frock, Hair Net & Shoe Covers)

· While performing the duties of this job, the employee is frequently required to communicate and provide guidance.

· Specific vision abilities required by this job include close vision and ability to adjust focus.

• Ability to lift at least 30-35 lbs.
• Ability to work in walk in refrigerator for long periods of time as needed

Computer Skill(s)

• Knowledge of Microsoft Office Suite (i.e. Word, Outlook, Excel, and PowerPoint)
• Knowledge of Adobe Acrobat, and Internet (i.e. Microsoft Edge, Explorer, Chrome)

· Knowledge of JDE system and/or an inventory management system