Job Title

Position Description

• Oversee and coordinate day-to-day activities of fermentation team along with support technicians/lab aides to ensure smooth operation of cGMP fermentation activities.
• Report any issues that might impact fermentation to the Manager of fermentation, to which this position reports.
• Provide training to fermentation staff on fermentation processes and SOPs/BRs for GMP production. Coordinate all GMP activities including hands-on GMP fermentation.
• Write and review batch records as required.
• Complete QA batch record review.
• Coordinate/schedule fermentation department activities with cross functional departments (QA, FE, QE, PP, etc.) to maintain cGMP compliance. 
• Responsible for meeting production schedules within stated time frames and within both quality and cost objectives. 
• Recommend new processes, equipment, etc., to make operation more efficient. 
• Prepare lead technician employee evaluations.

Position Responsibilities

• Oversee and coordinate day-to-day activities of fermentation processes and fermentation staff in meeting the biopharmaceutical manufacturing in accordance with cGMP guidelines.
• Responsible for the training and maintenance of training binders for fermentation staff.
• Oversee and ensure the maintenance and performance of reactors and general upkeep of manufacturing fermentation GMP suites. 
• Ensure all raw material needs and supplies are available and maintained by fermentation staff. 
  Review and approve all LUMAC(s) related to Manufacturing fermentation. 
• Plan, coordinate and assist in the set-up of all the GMP fermentation activities and ensure suites and bio-reactors are functional for usage.
• Review the executed Production Batch Records and submit for Manager’s approval.
• Lead in the preparation and maintenance of cell bank inventory within the manufacturing Fermentation department.
• Coordinate all the routine maintenance and preventive maintenance activities with Facility Engineering and outside vendors. 
• Ensure the timely completion of work and in meeting our operational standards. 
• Collaborate with Pilot Plant fermentation for training and transfer processes when needed. 
• Work closely with Pilot Plant fermentation to troubleshoot manufacturing  processes.
• Perform trouble-shooting of instruments and processes.
• Perform technical training on the production floor and in a classroom setting.
• Batch Production Record Review.
• Execute in process/equipment validation protocols.
• Write technical development reports and, when necessary, give oral presentations of data at departmental or interdepartmental meetings.
  

Position Requirements

• Bachelor’s of Engineering in Biochemical Engineering/ Chemical Engineering, B.Sc./ M.Sc. in biology or related field with >8  years of relevant experience
• Minimum 5 years experience supervising a fermentation operation in a pharmaceutical or regulated environment.
• In depth experience in development and manufacturing of recombinant proteins by fermentation/ cell culture.
• Knowledge of hardware and software used in fermentation processes at intermediate to commercial scale (130L-2750L).
• Would possess comprehensive, hands-on experience with process equipments and ability to trouble shoot them.  
• Must possess a thorough knowledge of cGMPs and process validation requirements.
  

• Director of Quality Assurance

Position Description

• Providing leadership and direction for Quality Systems departments including Quality Assurance Operations, Finished product Batch Release, Document Control and Validation.

Position Responsibilities

• Monitoring of day-to-day manufacturing operations to assure that the production processes are in compliance with and followed as per the FDA guidelines, written Operating procedures and company policies.
• Ensure that the raw materials used in the production are from the qualified/approved vendors, meet internal quality testing specifications and not counterfeit.
• Ensure that the drug products to be commercialized comply with the quality testing specifications and meet standards for safety and efficacy for the consumers.
• The packaging components such as containers-closures have appropriate labeling instructions, and child resistant and tamper evident features to ensure safety of the customers.
• Ensure that all departments are in compliance with cGMPs, FDA guidelines, SOPs and company policy.
• Advise other departments about quality assurance issues that impact their realm of responsibility.
• To ensure safety, efficacy, and purity of the drug products manufactured and commercialized.
• Direct the activities in the following area:
      Manufacturing Quality Operations – inspection of compounding, labeling, and packaging operations to ensure compliance with established procedures,               policies, guidance’s and FDA GMP regulations.
      All phases of documentation review and approval
      Change Control review and approval
      Document Control department procedures, policies, and operation
      Batch Release department procedures, policies, and operation
      Validation – Process Validation, Cleaning Validation, Computer Validation and Equipment Qualification
• Direct operations, engineering, maintenance and quality assurance personnel in investigating Manufacturing/Quality Assurance related problems, suggests resolutions and makes decisions on the manufacturing operations. 
• Seek efficiency improvements in productivity and quality without compromising the FDA regulatory and compliance standards.
• Responsible for establishing and managing budgets for the reporting departments.
• Participates in audits conducted by regulatory agencies and consultants. 
• Assists VP of Quality Systems in developing and implementing systems, evaluating procedures, plans and policies to ensure product integrity and compliance with the current FDA guidance.
  
  

Position Requirements

• MS with six or more years or BS with 10 or more years of experience in a pharmaceutical manufacturing organization with at least three of those years in a Quality Assurance and/or Validation role at a management level. 
• Thorough understanding of FDA GMP regulations and experience in handling Regulatory inspections.
• Good knowledge of pharmaceutical formulation and manufacturing processes is desirable.
• Excellent communication and technical Writing Skills.
• Excellent computer skills in basic softwares.