I: Job Summary (2-4 sentence description of overall job purpose)

The Bioprocess Specialist position reports to Supervisor/Manager Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB).  Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites.  This position will collaborate with manufacturing development, functional managers and manufacturing associates in executing various manufacturing processes using multiple manufacturing platforms.

II: Essential Functions

• Operates pharmaceutical manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment.
• Assists in identifying, planning and implementation of innovative technological programs and solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost effective manner. 
• Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures.
• Interfaces, schedules and performs on-site monitoring of outside services of all manufacturing equipment.
• Acts as qualified trainer for pharmaceutical manufacturing equipment.
• Ensures all safety and compliance procedures are followed at all times.
• Assists with investigations and problem resolution and provides clear and concise communication to supervisor/management.
• Executes projects with minimal instruction and management oversight.
• Assists manufacturing development for tech transfer activities and process design.
• Executes batch records according to GMP and site quality standards.
• Writes and revises controlled documentation (SOPs, Forms, Technical Reports, Batch Records, Protocols, etc.)
• Responds to off-hour alarms as assigned by the Manager Manufacturing
• Executes manufacturing cleanroom changeover and activation
• Assists Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

I: Job Requirements

• Bachelor degree in relevant field required or sufficient scientific and technical depth has been achieved from professional experience.
• Minimum 5 years of GMP pharmaceutical experience
• Expert knowledge of the installation, operation, cleaning and maintenance of pharmaceutical manufacturing equipment
• Knowledgeable of application and practices of current GMPs, international regulatory requirements and guidelines.
• Computer literate (Word, Excel and PowerPoint)

4. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.