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Manufacturing Scientist- Microbiology

Elanco

Last Updated: 11/01/22

Job Description

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Elanco Microbiologist

Company Overview

Who We Are:

Elanco is a global research-based company that develops and delivers products and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 9,000 employees in more than 70 countries. Our worldwide headquarters and research facilities are located in Greenfield, Indiana.

Requirements:

  • Currently attending school and will be graduating with a B.S. or M.S. in Microbiology, Biology, Biotechnology, or related field.
  • A track record of highly effective communication, interpersonal skills, and teamwork is essential.
  • Preferred candidates have relevant work experience in an academic, industrial microbiology, or small-scale analytical laboratory.
  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B status) for this employment position.

Travel Percentage

  • 0-10%

The positions are entry level scientist positions in the Tech Services Manufacturing Sciences (TSMS) or Quality organizations. They will be made available beginning in Jan 2023 (for Dec ’22 grads) or Jun 2023 (for May ’23 grads) and will be in areas such as science and technology, direct process support, and/or analytical laboratory support. The positions expose one to the technology, science, and regulatory requirements for making commercialized animal health medicine and products in multiple therapeutic areas.

Scientists actively contribute to the TSMS and Quality organizations, building a comprehensive understanding of the pharmaceutical industry, and the role scientists play in creating solutions for Elanco US Inc. Scientists interact with other engineering, manufacturing, development, and other science professionals.

Fermentation Technical Services/Manufacturing Sciences

Position Description

The Technical Services/Manufacturing Science (TS/MS) Scientist is responsible for variability reduction, process monitoring, process improvement, process validation, manufacturing ticket maintenance and overall technical support for processes in the Animal Health Manufacturing (AHM) organization at Clinton Laboratories. The TS/MS Scientist works within a framework of fermentation (processes in regulatory compliance, capable, in statistical control and continuously improving) and will function as a technical resource in manufacturing areas. The TS/MS Scientist will act as a business partner with manufacturing and will work closely with technical associates to establish and maintain best practices

Functions, Duties, Tasks

  • Provide technical support and leadership on capital projects, which include selecting appropriate improvements, defining scope, overseeing design/construction, and performing qualification.
  • Be knowledgeable on the computer systems to aid in troubleshooting the process and equipment, analyzing data, and conversing with the operators.
  • Ensure variations in the process are monitored and any significant trends are investigated, using the event management system as necessary.
  • Ensure changes to the process and equipment are documented through the change management system.
  • Analyze production data to identify improvement opportunities to process and productivity.
  • Work in close conjunction with fermentation development team to establish models which adequately mimic existing and potential new processes.
  • Partner with development team to run pilot and full-scale trials for commercial and pipeline material.
  • Maintain control and capability of all processes.
  • Maintain clear and understandable batch production records.
  • Maintain process flow documents (PFD) for each process.
  • Deliver internal presentations and research reports.
  • Validate process changes and new processes.
  • Maintain an accurate Bill of Materials (BOM) for each product

Minimum Qualification

  • Proven experience with aseptic technique.
  • Effective communication skills
  • Scientific data collection and documentation skills
  • Efficient approach to trouble shooting/problem solving
  • Ability to respond to changing priorities
  • Sound technical understanding of the process
  • Customer focus
  • Innovation and creativity

Additional Preferences

  • Good work ethic
  • Quality conscious
  • Technical growth and application
  • Self-management skills
  • Willingness to learn
  • Some statistical training

Quality Control Microbiologist

Position Description:

The analytical microbiologist is responsible for providing technical support for Clinton Quality Control to ensure compliance with cGMP, safety and company requirements. The analytical microbiologist interacts with laboratory technicians and supervision, Quality Assurance, manufacturing, and technical services to solve problems, improve laboratory practices and methods, and to implement improvement in business processes. The role is responsible for ensuring appropriate review and approval of all analytical data, managing analytical investigations, and coaching/mentoring of Quality Control technicians.

Responsibilities

  • Independently perform laboratory tasks using aseptic techniques. Tasks include culture inoculation and incubation, reaction sampling and extractions from microscale to multiple liter scale.
  • Perform QC microbiological testing such as bioburden, endotoxin, TOC, Conductivity
  • Perform environmental and utility monitoring according to local guidelines.
  • Coordinate with fermentation sterility team to perform culture purity testing and microbial identification assays on in-process broth samples.
  • Accurately and safely perform analytical test methods or related support activities as per procedures or protocols. Uses technical knowledge in the review and interpretation of data for conformance to procedures, standards and protocols and/or real-time recognition of aberrant data and results.
  • Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.
  • Recognizes when a deviation from procedures and operating ranges has occurred and initiates and participates in a Root Cause Investigation.
  • Assist in improvement of quality systems by creating or revising worksheets and other lab documentation systems.
  • Identifies and communicates opportunities for improvement initiatives in daily work activities. Authors change controls, deviations, and risk assessments.
  • Write protocols for non-routine testing or validation with appropriate guidance.
  • Collaborate with other Elanco scientists and laboratory technicians on the safe and correct use of equipment and support systems.
  • Document work consistently using appropriate data collection tools. Demonstrate proficiency in standard software platforms such as Excel, PowerPoint, and Word.

Additional Preferences:

  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Knowledgeable of cGMP requirements and laboratory operations.
  • Proficiency with computer systems including Microsoft Office products, LIMS, SAP, Empower, SmartLab, Veeva Systems, etc.
  • Ability to work in a lab environment including wearing appropriate PPE and other safety required equipment and considerations. Some exposure to allergens possible in laboratory environment.
  • Demonstrated strong math and documentation skills.
  • Demonstrated strong oral and written communication and interpersonal interaction skills.
  • Demonstrates ownership and accountability.
  • Self-driven and ability to work independently.

Additional Information:

  • 8 hour days – Monday through Friday
  • Respond to night/weekend phone calls as necessary

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

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



Company Details

Greenfield, Indiana, United States
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health...