Lead Manufacturing Associate

Emergent BioSolutions is committed to assisting employees achieve their professional goals.  Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their  career management.  This enables current employees who have remained in their current position for a minimum of one year to apply for an open position.

I.    JOB SUMMARY 

Execute tasks per CGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing training program. Actively incorporate the Shared Values set out by Emergent BioSolutions while performing day to day activities.

II.    ESSENTIAL FUNCTIONS
General

• Complete training and demonstrate competency on Lead Manufacturing Associate qualification blocks in accordance with the training progression pathway
• Execute and document procedural steps in compliance with CGMP standards, clean room behavior and Standard Operating Procedures
• Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as CGMP, GDP, EH&S regulations, and company regulations such as the employee handbook
• Maintain state of facility environmental control including preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing areas per Standard Operating Procedures  
• Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform “real time” review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift
• Stock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials
• Perform bubble point integrity testing of hydrophilic and hydrophobic production filters using defined test programs 
• Ensures that all Batch Production Records are requested and obtained in accordance with the production schedule
• Verification of Facilities department execution of preventive maintenance of equipment.  Requires thorough understanding of GMP equipment operation and function for intended purpose

Leadership

• Proactively recognize potential issues with manufacturing process equipment and troubleshoot in collaboration with Facilities/Maintenance
• Make decisions and escalate manufacturing and quality issues to management in a timely and effective manner
• Participate in self inspections and 6S audits and respond to findings
• Show personal commitment and acts to continuously improve
• Builds networks and engages in/runs meetings
• Holds self-accountable as well as peers
• Displays strong core values and cultural responsibilities
• Capable of scheduling and coordinating daily tasks

Lean Concepts

• Contribute to the development and promotion of standard work
• Collaborate with applicable Integrated Process Teams to drive continuous improvement and learn new Lean concepts
• Oversee and actively participates in Kanban and 6S systems
• Identify continuous improvement opportunities and collaborates with Integrated Process Teams and Supervisors to drive initiatives through to completion

Inspection and Packaging

• Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification)
• Independently operate labeling equipment with minimal supervision (Qualification)
• Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation)
• Package product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging)
• Complete ambient tracking documentation
• Execute material issuance and confirmation of process steps using specific SAP modules

Building 55 Operations – Prep

• Execute material issuance and confirmation of process steps using specific SAP modules
• Precisely weigh and hydrate media components
• Load, run and unload parts washer and sterilization/decontamination using specific validated load configurations per Standard Operating Procedures
• Assemble clean process glassware configurations and portable tanks utilizing sanitary connections, quick connects and stainless-steel ancillary parts
• Perform Cleaning (COP/CIP) and Sterilizing (SOP/SIP) of production vessels through interface with automated control system (DeltaV)
• Prepare and dispense intermediate materials

Building 55 Operations – Upstream 

• Execute detailed manual and high impact process tasks requiring extensive documentation and interface with automated controls.   Process operation involves manual orientation of valve configurations and monitoring/adjustment of vessel pressures during execution to maintain the sterile envelope and create differentials to facilitate transfers.  Description of specific requirements include:
• Clean and Sterilize 10L, 120L and 1320L fermenters to defined and validated parameters through interface with automated control system 
• Sterilize media filters and sterile filter seed, intermediate and production media 
• Prepare and dispense Saline for Inoculum for 10L fermentation initiation
• Inoculate 10L fermenter through addition of inoculum via peristaltic pump  
• Monitor culture turbidity to verify growth to required process parameters and transfer culture from the 10L to 120L and the 120L to 1320L fermenters upon verification of achievement of these parameters
• Adjust pH of culture through manual addition of 2N NaOH aliquots to a defined pH range 
• Install sterilizing grade filters, perform integrity testing and execute sterilization of filter skid 
• Monitor culture turbidity to verify growth to required process parameters and filter culture from 1320L fermenter to Harvest Tank

Building 55 Downstream Operations

• Add ALOH to Harvest tank.
• Draw samples and submit them through LIMS. 
• Clean and sterilize Harvest Tanks
• Clean and sterilize centrifuge as well as run the centrifugation processes
• Dispense and sterilize ALOH
• CPG addition
• Final Filtration

Quality Systems

• Initiate Non-Conforming Events and perform/document all necessary containment activities. Accurately complete triage assessment tool and proactively assist NCE author with investigation
• Escalates non-conforming events to Manufacturing leadership in real-time to ensure appropriate containment and immediate corrections are completed
• Initiate changes in the change control system regarding periodic review document revisions
• Revise existing procedures in the document management system
• Assist author with investigation of root cause, impact assessment and identification of durable corrective and preventive actions 

Training

• Train all levels of associates - Complete and maintain Qualified Trainer training qualification.  Qualification includes strategies for trainee motivation and competence development, adult learning principles, step by step training guide and proper documentation of all activities to ensure crediting of qualification status

Behavior/Cultural Responsibilities

• Standing Shoulder to Shoulder (no matter what):
  • working collaboratively with others, communicating, and managing conflict effectively
• Break Through Thinking:
  • cultivating innovation and nimble learning
• Own It Always:
  • ensuring accountability, and making good and timely decisions
• Compete Where It Counts:
  • demonstrating courage and focusing on customers
• Integrity and Instills Trust:
  • gaining the confidence and trust of others through honesty, integrity and authenticity
• Manages Complexity:
  • making sense of complex, high quantity, and sometimes contradictory information to effectively solve problem
• Plans and Aligns:
  • plan and prioritize work to meet commitments aligned with organizational goals
• Drives Engagement:
  • creating a climate where people are motivated to do their best to help the organization achieve its objectives

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• HS Diploma 
• Minimum of 4 years of experience working in a cGMP environment  
• Knowledge and understanding of cGMP and CFR requirements
• Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Culturally aware
• Able to work independently with limited supervision 
• Strong mechanical aptitude as determined by trainer assessment

If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $57,500 to $69,500. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data.  The salary may also be adjusted based on applicant’s geographic location.  Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*.  Information regarding additional benefits can be found here:  https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.