Scientist - BR&D Purification Scale-up Facility
About The Position
The Bioproduct Research and Development (BR&D) organization strives to deliver creative medicines to patients through the development and commercialization of insulins, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy modalities. This organization is a multidisciplinary group that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, scientists and engineers have full access to our scientific excellence and engineering capabilities. As a Scientist in the Process Scale-up Facility of the Bioproduct Purification Development group, you will work with other development scientists to develop and test new technologies and supply material to be used in research and toxicology studies. Your work and input will be key to the design of optimized downstream drug substance processes for a variety of new biological pharmaceutical candidates. Work can be fast paced and dynamic, often requiring simultaneous support of multiple projects. Strategic thinking, problem solving to overcome technical hurdles and the ability to execute intermediate scale manufacturing operations such as column chromatography, depth filtration, and tangential flow filtration are critical for success with this role. Day-to-day responsibilities will vary, and you should be flexible and adaptable to maintain cohesion in a small lab-team environment while accepting new projects and challenges. A strong scientific foundation and willingness to support process activities are prerequisites for this role. In addition, the ability to exhibit a high level of attention to detail, a quality-minded approach to experimental design, and record keeping are essential. Maintaining accurate records and interpreting data to provide detailed information and analysis on the execution of campaigns will be a daily activity. Writing technical reports, tech transfer documents and describing process development activities are important deliverables. This role requires effective interaction and communication of technical information with but not limited to; Safety, Environmental and Quality Team members, Purification Development colleagues, CMC team members, Discovery team members, Analytical Services, Tech Service/Manufacturing Science representatives, Operations, Engineering, Regulatory and Maintenance personnel. Especially important, in this role, is that you adhere to all safety and environmental guidelines and promote a proactive safety culture and environmental compliance in all areas.
Requirements
- Bachelor's degree in scientific, engineering, or related technical discipline
- 3+ years of relevant hands-on experience in bioprocessing in a manufacturing and or Development pilot plant environment
- Working knowledge of basic chromatography principles and scaling parameters for packing and running production-scale columns
- UNICORN control system/software hands-on experience for running production scale chromatography unit operations
- Demonstrated experience managing production schedules in Smartsheet or a comparable tool, and authoring processing tickets/work orders for downstream purification unit operations
- Strong organizational skills and clear communication across technical and non-technical stakeholders
- Demonstrated laboratory or production area work experience with a safety-first mindset
- Effective oral and written communication skills
Nice To Haves
- Process experience generating biologics
- Downstream drug substance processes including purifying and filtering monoclonal antibodies, recombinant proteins, viral vectors, or peptides
- Experience with scale up process development and tech transfer
- Experience with working with hazardous materials/training and experience with safety protocols, and corrective and preventive actions
- Downstream purification experience with different types of chromatography unit operations (affinity capture, ion exchange, hydrophobic interaction, mixed mode) and also filtration operations (depth filtration, tangential flow filtration)
- Strong laboratory skills
- Willingness and aptitude for manual and mechanical-based labor for larger scale unit operations in a pilot plant environment
- Strong team player attitude
- Experience with process control and electronic notebook documentation systems
- General interpersonal and communication skills; mentoring, feedback, training, and cultivating an environment for learning and open/honest communication
- Experience with data trending and data visualization
- Planning skills in a compressed campaign schedule environment, both coordinating with operations, and scheduling stakeholders to align resources and equipment with timelines
- Advanced problem-solving skills
Responsibilities
- Develop and test new technologies
- Supply material to be used in research and toxicology studies
- Design optimized downstream drug substance processes for a variety of new biological pharmaceutical candidates
- Execute intermediate scale manufacturing operations such as column chromatography, depth filtration, and tangential flow filtration
- Maintain cohesion in a small lab-team environment while accepting new projects and challenges
- Maintain accurate records and interpret data to provide detailed information and analysis on the execution of campaigns
- Write technical reports, tech transfer documents and describe process development activities
- Adhere to all safety and environmental guidelines
- Promote a proactive safety culture and environmental compliance in all areas
- Author, review, and route processing tickets that define scope, materials, parameters, and documentation requirements during campaigns
Benefits
- Company bonus (depending, in part, on company and individual performance)
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- Prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- Life insurance
- Death benefits
- Certain time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
