Posted in General Business 30+ days ago.
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Position Description: Performs the below duties within TSMS with minimal supervision: 1) Is responsible to assist in the initiation and completion of customary procedures via current documentation guidelines in transition of new R&D projects to operations units in an efficient manner; 2) Is responsible to provide assistance in development of process(es), optimization of process(es), confirmation of process(es), validation and manufacturing of qualifying and pre-licensing serials; 3) Is responsible to communicate work orally and in writing by treating reports and data with a high level of integrity and ethics and can complete roles and responsibilities as a Sub-Team member; and 4) assists in improving consistency, stability and yields.
Duties: 1). Operate in a compliant manner at all times with respect to good documentation practices and current SOP’s related to experimentation, reporting data and training. 2). Write protocols, conduct experiments and generation of reports for studies and treats all data with a high level of accuracy, integrity and ethics. Requires analysis of possible solutions to solve a range of problems. 3). Assist or lead in the transfer and scale up of new processes from Development to operations units by assisting in the development, optimization and confirmation from small to large scale. 4). Assist or lead in optimizing current processes by conducting experiments to evaluate different growth parameters, medium components and new equipment. Ensures equipment is kept in operational status. Participates in the transfer of production processes across different geographical sites.
Required Capabilities: Must have the ability to operate instrumentation/equipment and learn new technology and concepts. Concise and accurate reporting of technical data and information. Must have basic lab skills, preferred experience with bacteria, viruses and cell culture. Basic understanding of processes related to bioreactor/fermentation and exposure to lyophilization a plus, and preferred hands on experience with formulation of biological products and operation or reactors and cell culture equipment. Ability to troubleshoot problems and take corrective actions to solve the problem. JMP® Statistical analysis of data experience is preferred. This position performs experimental designed (DOE) to enhance and/or develop vaccine manufacturing processes, and to investigate problems related to biological products. Hands on participation will be required for both small scale and large-scale bioreactor/fermenter processes.
Demonstrated ability to work within diversely populated teams and networks.
Management & Economic Magnitude: No leadership experience required. This is an individual contributor role.
Education/Experience: BS in a relevant scientific discipline required + 2 - 3 years relevant experience preferred or, MS in a relevant scientific discipline, relevant industry experience preferred.
Other Information: This individual will interface within Technical Services Material Sciences (TSMS) Team regardless of site and, but not limited to: R&D, Operations, Assay Development, Quality Control, Quality Assurance, Document Control and Supply Chain departments. Works under limited supervision following established procedures or instructions. Works in a matrixed organization structure within Operations and R&D. Occasionally may work non-standard hours dependent on experimental and process control needs.
Physical Demands / Surroundings:
o Lifting, carrying, pushing or pulling up to 50 pounds occasionally
o Frequent periods of sitting, walking, and standing
o Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
o Occasional low level work, fine finger dexterity/ including grasping or pinching required
o Writing and use of a computer keyboard frequently
o 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.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status