Scientist II/Senior Scientist - Analytical Science

Employment Type

:

Industry

: Miscellaneous



Description:

Scientist II/Senior Scientist – Analytical Science (#211618)

Description\:


Analytical Development Scientist with focus on bioassay analytical method development and characterization activities in support of innovative biopharmaceuticals development. The successful candidate will support method development and support qualifications of potency methods for biologics (e.g., cell-based and ELISA-based bioassays) and/or impurity methods for biologics (e.g., HCP and Protein A ELISAs), and support method validations in accordance with ICH guidelines. In addition, the successful candidate will may represent Analytical Science on CMC teams and provide leadership for development programs.  

Member of team with occasional role as line representative on a Process Science team. Frequently executes complex experiments in team setting with daily interaction with team. Independent troubleshooting for methods is required. Capable of analysis of complex data on frequently encountered problems. Has discretion in tactical execution of experiments and analysis. Represents work at functional area meetings and process science meetings. Will present at conferences and occasionally to customers.

This position will lead planning and executing assay development of bioassays within the Process Science department. The position will apply scientific principles, process knowledge and experience in analytical method development to design, perform, analyze and document experiments independently. From well-defined experiments, this position will interpret data, provide data summary and develop solutions independently, with other scientists, and with cross functional teams.

This position will prepare technical reports and protocols and will contribute to the development of new methods and technology. This position will be responsible for supporting other scientists and making improvements in equipment, software, and workflow. This position works in close collaboration with scientists in the Process Sciences functional groups and provides comprehensive development expertise in analytical science area. 

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to contribute directly to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities\:

  • Leads the development and optimization of and scientific troubleshooting for analytical methodologies required to ensure, high quality and safe product to support pre-clinical and clinical studies, and commercial manufacturing with specific focus on quantitative impurity measurement (ELISA) and potency evaluation (cell-based bioassay).
  • Plans/leads planning and executing experiments in support of analytical method qualification and product characterization.
  • Performs comprehensive data analysis of method statistics independently, identifies method deviations, drafts analytical methods and technical reports, and proposes comprehensive solutions and improvements.
  • Contributes to project strategy and planning and may lead a small team in pursuit of set goals within a single discipline. Drives the development of analytical methods.
  • Participates in training and development opportunities in order to gain an understanding of standards of practice, process science and departmental policies.  Provides comprehensive training and guidance to more junior scientists.
  • Develops technical solutions to problems independently and proactively exchanges technical information with team members within Process Science and with cross functional groups for troubleshooting and ongoing support.
  • Identifies, proposes, and executes process and procedural changes to improve business performance, method performance, robustness, productivity and efficiency.
  • Leads project planning and execution including evaluation of equipment and implementation of appropriate modifications and staff training to ensure employee safety. Ensures analytical equipment used in science labs are maintained per preventive maintenance schedule.
  • Supports direct communications with external and internal customers to ensure methods meet specifications and requirements, and supports transfer of methods to our QC department, including troubleshooting.
  • Assists in acquisition and efficient transfer of analytical methods from third parties and if required, implementation of method adaptations.
  • Assists continuous improvement in innovation and technology, and in the establishment of state-of-the-art technologies for method development.
  • Supports critical reagent procurement and inventory management for analytical methods within Process Science.
  • Ensure successful development & transfer of analytical methods for therapeutic biologics to manufacturing or QC, including CMO and NBE/Biosimilar projects, including authoring methods, study plans and reports.
  • Responsible for effective development of biopharmaceuticals by implementing decisions with internal and international partners as well as with regulatory agencies.
  • Manages interfaces, maintains flexibility, and prioritizes workload in order to complete complex and variable projects tasks.
  • Collaborates closely with other Senior Scientists, Lab Heads, Principal Scientists, and partners.
  • Identify and establish state-of-the-art technologies for analysis (including asset management).
  • Mentors, coaches and develops staff and supports capability and skill level improvement.
  • Develops standards around which lab staff members operate and is accountable for administration and results in his/her functional areas. (Sr Scientist)
  • Permanent development of a technically & scientifically oriented team to ensure personal development, increase flexibility and improve processes. (Sr Scientist)
  • Provides effective management of the Analytical Science group within a project matrix concept. (Sr Scientist) 
  • Possession of ability to motivate and develop employees. (Sr Scientist)
  • Compliance with regulatory guidance regarding method qualification and validation, knowledge of regulatory dossiers and GMP requirements, safety at work (EHS) and customer relations/visits (internal/clients)
  • Ensure worker safety including training, supervision and control of safety guidelines.
  • Understand current regulatory guidelines for production of human recombinant products, including process or method validation.

Scientist II Requirements\:

  • Doctoral degree in Chemistry with up to two (2) years’ relevant experience and/or Masters’ degree in Biochemistry plus two (2) to four (4) years’ relevant experience and/or Bachelors’ degree in Biopharmaceuticals plus four (4) to six (6) years’ relevant experience.
  • Analytical method development experience with bioanalytical techniques such as ELISA, cell-based bioassay, BLI/SPR.
  • Experience in cell based potency and ELISA method development and mammalian cell culture (BSL2)
  • Experience with iQue 3 flow cytometry a plus
  • Tech transfer experience
  • Experience participating in CMC teams is highly desirable.
  • Experience in critical reagent management.
  • Statistical analysis skills and working knowledge of SoftMax Pro
  • Experienced in authoring technical documents such as standard operating procedures, test methods, study protocols, and reports.
  • Broad protein analytical chemistry knowledge and/or broad knowledge of analytical technologies supporting analysis and characterization of protein based therapeutics.
  • Understanding of method development and validation per ICH regulations.
  • Knowledge and broad understanding of the cGMP requirements as they apply to the Biopharmaceutical industry. Good understanding of relevant USP methodologies and ICH guidelines.
  • Good multi-tasking, time management and organizational skills are essential.
  • High competence in Microsoft Office Suite.
  • Possess excellent verbal and written skills.
  • Operational Excellence
  • Knowledge of Six-Sigma and LEAN are helpful.

Senior Scientist Requirements\:

  • Doctoral degree in Chemistry plus up to four (4) years’ relevant experience and/or Masters’ degree in Biopharmaceuticals plus three (3) to six (6) years’ relevant experience and/or Bachelors’ degree in Biochemistry plus five (5) to eight (8) years’ relevant experience.
  • Analytical method development expert with bioanalytical techniques such as ELISA, cell-based bioassay, BLI/SPR.
  • Extensive hands-on experience in the release/stability development, optimization and qualification/validation of potency methods for biologics (e.g. ELISA, cell-based bioassay, BLI/SPR).
  • Strong experience in cell based potency and ELISA method development and mammalian cell culture (BSL2)
  • Experience with iQue 3 flow cytometry a plus
  • Tech transfer experience with cell-based bioassays
  • Experience participating in and leading CMC teams is highly desirable.
  • Critical reagent characterization, procurement and inventory management experience.
  • Statistical analysis skills and working knowledge of SoftMax Pro
  • Experienced in authoring technical documents such as standard operating procedures, test methods, study protocols, reports, method qualifications and related scientific documents.
  • Broad protein analytical chemistry knowledge and/or broad knowledge of analytical technologies supporting analysis and characterization of protein based therapeutics.
  • Understanding of method development and validation per ICH regulations.
  • Knowledge and broad understanding of the cGMP requirements as they apply to the Biopharmaceutical industry. Good understanding of relevant USP methodologies and ICH guidelines.
  • Good multi-tasking, time management and organizational skills are essential.
  • High competence in Microsoft Office Suite.
  • Possess excellent verbal and written skills.
  • Operational Excellence
  • Knowledge of Six-Sigma and LEAN are helpful.

Eligibility Requirements\:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required)
  • Must be 18 years of age or older

Who We Are\:

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.


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