Position Description:

The Scientist II position will support cGMP manufacturing activities to ensure that Thermo Fisher provides clients with investigational materials for pre-clinical and clinical use. This position will perform hands on cGMP production of Master Cell Banks (MCB), Master Viral Banks (MVB), recombinant protein and viral vectors under the supervision of the Upstream Manufacturing Supervisor/Manager. Will work with the Upstream Manufacturing Supervisor/Manager to trouble-shoot technical problems. Will also review executed records related to production activities, write or review deviations, investigations, etc. related to cGMP production. Will be expected to prepare and modify documents (SOPs, PBRs, RMSs, qualification protocols, etc) required for cGMP production, and to maintain the equipment in the upstream production suites. Will also work closely with Production Development, Facilities, Quality Assurance, and Quality Control units to achieve production goals and timelines.

Essential Responsibilities:

• Production (50%)
  • Organize and coordinate upstream manufacturing activity efforts in production suites
  • Execute hands-on cGMP manufacturing with other team members and follow detailed protocols, PBRs and SOPs, to complete production runs in an efficient, safe and correct manner. Prepare and/or request necessary components and raw materials, labels, etc. to successfully execute production batch records
  • Ensure that upstream manufacturing modules operate efficiently and meet timelines and schedules through performing required calibration, cleaning, equipment preventative maintenance as required by SOP and the review of material inventory
• Prepare and Review Documents (45%)
  • Write process procedures including SOPs, batch records, qualification protocols, etc for new processes or equipment.
  • Write Change Controls, Planned Variances, Deviations and Investigation Reports as needed
  • Review executed Production Batch Records (PBR), and other production related documents
  • Coordinate and participate in the technical transfer of processes from clients and/or process development to manufacturing.
  • Search and source cGMP compatible equipment and raw materials.
• Other Duties as Assigned (5%)

Important Areas of Focus:

• Safety
  • Maintain a culture of safety by identification of near misses, safety walkthroughs, and assisting with resolution of safety observations. Ensure chemicals are properly stored and labeled.
• Quality Compliance
  • Adhere to the Quality Management System (QMS) by living the quality values everyday and holding peers accountable to the same standards.
  • Ensure documentation of all activities meets cGMP requirements.
  • Own the responsibility of on-time closure of nonconformances and CAPAs.
• PPI (Practical Process Improvement)
  • Implementation of PPI initiatives and continuous improvements under minimal direction.

Knowledge and Skill Requirements:

• A bachelor’s degree in an appropriate area of specialization (molecular biology, virology, biochemistry, immunology) and four years of appropriate experience in the same or related fields. Previous degree/experience requirements may be lessened by superior demonstration of skill sets or background.
• Preferred Qualifications:
  • PhD and two years of work experience in the fields of virology, molecular biology, biochemistry, and/or cell biology.
  • Hands on experience in cell culture (small and large scale), transfection, infections, rAAV production by transfection and using baculovirus systems.
  • An in-depth understanding and good knowledge of downstream processing methods.
  • Experience in a cGMP production and testing environment.
  • Excellent communication skills, including technical writing.

Work Hours:

• Typically, Monday through Friday, 7:30 AM to 4:30 PM
• Requires availability to work early in the morning, in the evenings, holidays, weekends, and overtime when required to meet timelines. These hours would be mandatory.

Physical Demands:

• 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.
• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
• Ability to apply concepts of basic algebra and geometry.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to communicate in a dynamic environment.