Sr. Engineering Scientist-Pharma/Drug Substance

KP Recruiting Group Chicago , IL 60290

Posted Yesterday

We are pleased to present the following job opportunity with our client! Take a look and if you meet the requirements please submit your resume and we'll be in touch if you're a good fit!

We'reseeking a highly motivated individual with a proven track record of accomplishment to join the API PilotPlant Technical Operations (Tech Ops) group. This position will serve as a liaison between the Process Researchand Development scientific functions and the API Pilot Plant organization.
The successful candidate will assist in theoptimization and scale-up of synthetic processes and facilitate the implementation of the processes and new technologiesin to the API Pilot Plant. The Scientist will also provide technical oversight during production campaigns and will supporttechnical transfer to the ultimate commercial manufacturing site.
Responsibilities:
  • Technical oversight of processes running in the API Pilot Plant, and responsibility for process-trouble shooting in collaboration with the project teams.
  • Serves as primary point of contact between API Pilot Plant, project teams, Quality Assurance, and Environmental Health and Safety.
  • Responsible for review and documentation of data for cGMP execution of chemical processes. Authors campaign summary reports.
  • Identify, evaluate and implement new technologies for the pilot plant and/or identify opportunities to modify or leverage existing assets to enhance operational efficiency. Examples include automation, flow chemistry, novel separation, Process Analytical Technology (PAT) feedback control and drying technologies.
  • Support the implementation of PAT. Assist with equipment specification, setup, data collection and analysis.
  • Interface with project teams to ensure that processes are safe and operable.
  • Partner with API development teams to optimize processes for scale-up. Identify appropriate equipment and configurations.
  • Assist with technology transfer of late stage processesto commercial sites, including process fit, identification of equipment needs, and facility modifications.
Basic:
  • PhD in Chemical Engineering with 4+ years of experience in the pharmaceutical industry
  • 3 Years (minimum) in drug substance development
  • Understanding of cGMP, process safety requirements, and OSHA chemical hygiene plans.
  • Working Knowledge of analytical techniques such as HPLC, GC, NMR, and microscopy
  • Experience with Process Analytical Technology
Preferred:
  • Experience with laboratory experiments, process scale-up from lab to pilot plant and/or transferring a process from pilot plant to a commercial facility.
  • Experience working in an API Plant environment. Familiarity with operation of chemical process equipment and systems.
  • Strong technical background in chemical processing unit operations including reactions, crystallization, distillation, extraction, membrane separation, chromatography, centrifugation, filtration, drying and milling.
Key Leadership Competencies:
  • Learns fast, grasps the "essence" and can change course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Process Scientist

Abbott Laboratories

Posted 4 days ago

VIEW JOBS 11/11/2018 12:00:00 AM 2019-02-09T00:00 At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. JOB DESCRIPTION: Summary: Will lead and consult on multiple complex projects defined for process investigations; design changes; resolving production issues and improving product availability and profitability. Leads a cross functional team with the required product/process knowledge to assess impact and develop plan. Focus will be in protein purification with one or more of fermentation, cell culture or recombinant protein experience. Responsibilities: Responsible for implementing and maintaining the effectiveness of the quality system. a. Quality/Safety: Demonstrate an understanding of the application of the Quality Policy through daily activities. Maintain vigilance to ensure adherence to the Quality Policy and system procedures by promptly reporting noncompliance issues to management. Safety: Work in a safe and environmentally responsible manner. b. Technical knowledge: Develop and apply operations and process knowledge to area of support. Use sound judgment; appropriate scientific methods and thorough data analysis. Accurately documents work c. Planning/Project Management: Conceive; plan; design; execute; and document projects/activities efficiently and in conformance with applicable OPs. d. Process and Patient Focus: Anticipates; identifies and resolves internal and external customer issues through understanding of production processes and its impact on process yield; product performance and clinical utility. e. Communication/Leadership: Demonstrates effective verbal and written communication skills within and outside immediate area. Shares and enhances own knowledge by mentoring and training others. f. Business Focus/Alignment: Demonstrates fiscal responsibility through actionable recommendations and accomplishments such as improving production process yields; decreasing production costs and maintaining product availability. Aligns resources with strategic business priorities. May perform other duties as assigned Scope: a. Achieves team and individual performance goals. Generates and manages multiple project timelines and resources. b. Mentors others in the areas of experimental design; production process analysis and improvement; technical writing skills for data analysis; investigation documentation and change control. c. Proactively identifies opportunities to improve compliance with QSR / ISO requirements. Confronts issues; motivates and influences others; negotiates and manages crisis to attain desired results. d. Listens actively; fosters information exchange; provides scientific and operational information effectively; establishes networks; and presents/defends positions. e. Develops strong networks throughout the Division. Inspires others toward the achievement of team/project objectives. Operates with integrity and respect; actively resolves conflicts. f. Participates in assessing and responding to internal and external changes. Recognizes and promotes acceptance of changes in internal/external environment. Makes timely scientific; operational; and business decisions; appropriately elevates high-risk decisions. Requirements: M.S. required in a scientific discipline (chemical engineering; chemistry; biology or biochemistry) plus 1-5 years' experience in a related field. Additional years of experience may offset degree requirements. Experience: Preferred: Expertise in the following disciplines at an industrial scale: protein purification with one or more of fermentation, cell culture or recombinant protein production. Demonstrated ability to apply operations knowledge in timely resolution of product / process technical issues. Experience with GMP. Experience with technical problem prevention / resolution. Experience with leading project teams and/or mentoring / teaching others. Knowledge of chemical process modeling and/or experimental design and/or statistical tools. Understanding change control impact on design / validation of products and/or processes. Experience in operations (manufacturing/quality). Experience with data management. Experience working in project teams for multiple complex projects. Experience with change control and/or investigation processes and/or laboratory skills. Experience with acquiring, analyzing and interpreting data from a variety of sources. JOB FAMILY:Product Development DIVISION:ADD Diagnostics LOCATION:United States > Abbott Park : AP08B Floor-3 ADDITIONAL LOCATIONS: WORK SHIFT:Standard TRAVEL:Yes, 5 % of the Time MEDICAL SURVEILLANCE:No SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott Laboratories North Chicago IL

Sr. Engineering Scientist-Pharma/Drug Substance

KP Recruiting Group