Scientist III, IV, Bioprocess Development
Description
Performs the below duties within Bioprocess Development without supervision:
- Is responsible to design and execute experimentation via current documentation guidelines in transition of new Research and Development projects to operations units in an independent and efficient manner.
- Is responsible to Provide Designing, Planning, Scheduling and Execution in development of process(es), optimization of process(es),confirmation of process(es), validation and manufacturing of qualifying and pre-licensing serials.
- Is responsible to Communicate work orally, in writing and in presentation format by treating reports and data with a high level of integrity and ethics and can complete roles and responsibilities as a Bioprocess Core Team Member.
- Design experimentation to improve consistency, stability and yields of product antigens.
- Assist in training/instructing other scientists when applicable.
Duties & Responsibilities
- Design, Schedule, Execute and Write protocols, conduct experiments and generation of reports for studies and treats all data with a high level of integrity and ethics.
- Remain compliant with documentation guidelines and current SOP’s related to experimentation, reporting data and training of themselves and sub-team members and to ensure all relevant documentation is appropriately archived.
- Lead transfer and scale up or scale down efforts of new processes from Development to operations units in the development, optimization and confirmation from small to large scale.
- Conduct optimization efforts of new or current processes by performing experiments to evaluate different growth parameters, medium components and new equipment.
- Responsible for set-up/configuration, operation and validation of new equipment. Ensures maintenance of equipment and it is kept in operational status. Coordinate with internal functions, vendors and/or engineering to evaluate new raw materials, consumables, or equipment.
Requirements
- BS from an accredited institution in a relevant scientific discipline required plus five to eight (5 -8) years of relevant experience preferred; Or MS from an accredited institution in a relevant scientific discipline, relevant industry plus (2) years of relevant experience preferred; Or PhD from an accredited institution in a relevant scientific discipline, relevant experience preferred.
- Must have the ability to operate and train team members on current instrumentation/equipment and learn then train new technology and concepts.
- Concise and accurate reporting of technical data and information.
- Must have basic and advanced lab skills.
- Experience with bacteria, viruses and cell culture.
- Understanding of processes related to bioreactor/fermentation, down-stream methods and lyophilization, hands on experience with formulation of biological products and operation of reactors and cell culture equipment.
- Ability to troubleshoot problems and take corrective actions to solve the problem.
- Statistical analysis of data experience utilizing Statistical software.
- This position will be expected to lead (with management alignment) and may assist higher level scientists in experimental designed to enhance and/or current processes, investigation of problems related to biological products, and to develop new or improve existing production processes.
- Leading team members and Hands on assistance will be required for both small scale and large scale bioreactor/fermentor processes, down stream processes and lyophilization processes.
- Physical Demands / Surroundings:
- Lifting, carrying, pushing or pulling up to 50 pounds occasionally
- Frequent periods of sitting, walking, and standing
- Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
- Occasional low level work, fine finger dexterity/ including grasping or pinching required
- Writing and use of a computer keyboard frequently
- Occasional use of personal protective equipment
- Visual / Hearing Demands: Color vision and depth perception required. May require extended hours at a computer screen. Must be able to read electronic documents of all types. Hearing acuity required.
SCI IV Requirements
- BS from an accredited institution in a relevant scientific discipline required plus eight (8) years of relevant experience; Or MS from an accredited institution in a relevant scientific discipline required plus four (4) years of relevant experience; Or PhD from an accredited institution in a relevant scientific discipline required plus two (2) years of relevant experience preferred.
- One to three (1-3) years of experience leading projects.