10 Targeted Biomanufacturing Job Descriptions
Process Development Associate
Responsible for evaluating, improving, and scaling-up manufacturing processes in order to improve product yield and reduce overall costs of production. Executes small-to-medium scale production work, which may involve cell culture, fermentation, purification, and/or chromatography. Additionally, assists with maintenance of production equipment. May research and implement new methods and technologies to enhance operations and may assist in validation of production processes.
View a short movie clip of an interview with a Process Development Associate
- Jen Plouffe (4.34 meg file, 13:43 time, 160x120)
- Jen Plouffe (10 meg file, 13:43 time, 320x240)
- Mary Goyette (4 meg file, 1:42 time, 320x240)
Responsible for developing and recommending validation strategies and designing studies for the purpose of providing documented evidence that a system, equipment, method, or process has been validated. Conducts and processes qualification programs, writes detailed protocols and reports to document the validation of systems/equipment, and provides validations support for facility and utility expansion, compliance upgrades, etc. Develops and implements solutions to validation issues. Knowledge of current industry practices and GMP requirements related to validation tasks is required.
- Dennis Woodby (11 meg file, 4:17 time, 320x240)
- Victoria Kelley (18 meg file, 6:43 time, 320x240)
Responsible for assisting manufacturing in specific product-related operations in cell culture and growth. Operates and maintains production equipment as it relates to cell culture (i.e., cell harvests and separation operations). Also performs fermentation. Operates and maintains production equipment related to fermentation (e.g., fermenters, bioreactors, centrifuges). Weighs, measures, and checks raw materials to assure proper ingredients and quantities. Prepares media and buffer components. Maintains records to comply with regulatory requirements and assists with in-process testing.
- John Condosta (4.3 meg file, 12:30 time, 160x120)
- John Condosta (10 meg file, 12:30 time, 320x240)
Responsible for setting up area operations, performing according to SOPs, and following electronic work instructions in accordance with a GMP environment to manufacture biopharmaceutical drug substances. Responsibilities include cleaning-in-place (CIP) and sterilizing-in-place (SIP) of equipment, column chromatography, ultrafiltration, diafiltration, conducting protein purification operations, monitoring control devices, and executing any other related operations pertaining to the process area. Also maintains records to comply with regulatory requirements and assists with in-process testing.
- Michael Onufrak (5.2 meg file, 16:00 time, 160x120)
- Michael Onufrak (10 meg file, 16:00 time, 320x240)
- Cybelle Mandigo (12 meg file, 4:28 time, 320x240)
Maintains, tests, troubleshoots and repairs a variety of circuits, components, analytical equipment and instrumentation. Calibrates instrumentation and performs validation studies. Specifies and requests purchase of components. Analyzes results and may develop test specifications and electrical schematics. Performs continuous monitoring of equipment status, condition and location. Prepares required documentation for the recording and notification of events and changes related to equipment such as calibration certificates, deviations, out of tolerances and installation reports. Knowledge and understanding of measurement parameters and experience working in a GMP environment is preferred.
Chemistry QC Technician
Performs a variety of inspections, checks, tests, and sampling procedures for the manufacturing process according to standard operating procedures (SOPs). Performs in-process inspection and documents results. Monitors critical equipment and instrumentation. Writes and updates inspection procedures and checklists as necessary. Requires knowledge of current good manufacturing practices (GMPs).
Microbiology QC Technician
Performs routine microbiological testing of raw materials, in-process samples and finished formulations according to Standard Operating Procedures (SOPs). Conducts routine environmental monitoring of GMPs, manufacturing areas, equipment and processes according to established procedures. Calibrates and maintains microbiology laboratory equipment. Compiles and analyzes data for documentation of test results and prepares related reports. Revises and updates SOPs as necessary.
- Jen Pachas (4.3 meg file, 12:30 time, 160x120)
- Jen Pachas (10 meg file, 12:30 time, 320x240)
Environmental Health & Safety Technician
Responsible for water and air sampling and monitoring, processing permits, calibration and maintenance of scientific monitoring, data collection and routine analysis. Installs and services recording instruments; maintains physical stations where data is collected, inspects stations records to ensure quality assurance and preventative maintenance procedures are conducted properly. May conduct special studies such as toxic water monitoring, biological monitoring, and air/water pollutant investigations and recommend corrective actions. Records and maintains periodic data logs and information files. Typically works from drawings, specifications, diagrams, schematics, and specific verbal and written instructions. Working knowledge in sampling, data collection and analysis, pollution complaint investigations, instrument calibration, and environmental law, or experience in assessing environmental conditions is desirable.
QA Documentation Coordinator
Responsible for providing clerical and administrative support related to documentation system requirements/maintenance. Audits all documentation manuals to assure they are accurate and up-to-date, and available to appropriate personnel. Maintains filing of all master documents and assists in all microfilming and archiving activities.
Performs daily monitoring, repair, and preventive maintenance activities on critical systems and facility equipment. Troubleshoots, installs, and modernizes new and existing systems, including refrigeration equipment, water systems, HVAC systems, and electrical systems. Documents repairs, adjustments, and replacement of equipment and/or components per GMP standards. May also provide input and corrections to SOPs and assist engineering in the evaluation of new equipment or technology. Knowledge of major trades, such as carpentry, electrical, plumbing, and HVAC refrigeration, including the ability to interpret blueprints, technical manuals, and specifications, is required.
* Source: Massachusetts Biotechnology Council's Overview of Biotechnology Industrial Jobs from the Massachusetts Biotechnology Directory at http://www.bio-link.org/issuesWorkforce.htm