Description: We are seeking highly motivated engineers and scientists to lead or support process development of large molecule biopharmaceuticals.
The Scientist will be expected to design and execute studies to develop process parameters, evaluate limits, assess robustness and recommend optimum process conditions for cell culture and/or purification steps.
The Scientist will also be responsible for scaling-up the developed steps to pilot and/or manufacturing scale to gain a full understanding of how bench-scale development culminates into viable clinical or commercial processes.
The successful candidate will work in high-performing teams, collaborate across technical functions, utilize sound scientific principles, and ultimately play a critical role in bringing innovative therapies to patients.
Responsibilities:
• Design and execute cell culture and/or protein purification studies at bench and pilot scale to develop bioprocessing steps for monoclonal antibodies and other complex biologics.
• Analyze and evaluate data and make sound conclusions based on scientific principles or statistical methodologies.
• Establish appropriate set-points and ranges leading to robust and repeatable process performance.
• Challenge current paradigm to significantly improve cell culture productivity, process yield and efficiency through implementation of new technologies, optimization of platforms and improved raw materials.
• Operate automated and semi-automated small and pilot-scale bioreactors and protein purification systems.
• Utilize high-throughput cell culture and purification equipment such as ambr15, ambr250 and liquid handlers.
• Perform process scale-up to pilot or clinical manufacturing scale equipment using engineering principles.
• Support pilot and clinical manufacturing as needed.
• Perform in-process analytical testing using Nova, cell counters, Solo VPE and other technologies
• Perform simple product quantity and quality analyses using technologies such as HPLC
• Working in teams, plan and schedule studies, develop timelines and create raw material usage plans.
Skills: GMP, Downstream, upstream, bioreactor, Downstream Manufacturing, Bioprocess, Immunotherapy, Protein Purification, Biologics, Bioreactors, Chromatography, Filtration, Assay, Protein reagents, upstream manufacturing Top Skills Details: GMP,Downstream,upstream,bioreactor Additional Skills & Qualifications:
• Bachelor’s degree in the life sciences, chemical or biochemical engineering or related field.
• 2 years of hands-on experience with process development studies using bench or pilot scale bioreactors, chromatography systems and filtration equipment.
• Experience with mammalian cell culture systems and purification of antibodies or biologics.
• Experience with operation and maintenance of in-process analytics such as Nova, cell counters, HPLC systems, SOLO VPE or other relevant technologies.
• Experience of authoring technical reports, brief technical presentations and conference posters and abstracts.
• Experience of design of experiments, simple statistical analysis and data interpretation.
• Preferred Qualifications (Position level maybe adjusted for candidates with significant higher experience and qualifications):
• Master’s or higher degree in the life sciences, chemical or biochemical engineering or related field.
• 3 or more years of experience in process development studies using bench or pilot scale bioreactors, chromatography systems and filtration equipment.
• Knowledge and experience demonstrated by scientific accomplishments with high productivity cell lines, cell culture systems or highly innovative protein purification strategies.
• Experience with use of engineering principles to perform process scale-up.
• Experience of media and/or feed optimization to significantly increase cell culture productivity.
They are open to someone with one year of manufacturing experience if they have good tenure (worked at one place since college) and are professional.
The pay for one year exp.
would be around $65K, 2-3 year exp.
$70K-$80K, and 4-5 years $90-$100K.
Experience Level: Entry Level About Actalent: Actalent connects passion with purpose.
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Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.