Scientist IV, Global Pharmaceutical Technical Support - Boehringer Ingelheim
North Brunswick, NJ
About the Job
Description
Under the general guidance of a more senior staff member or Head of the department, the incumbent is responsible for developing, validating and transferring robust analytical methods to support testing of APIs, excipients, raw materials and finished products related to marketed/commercial global pharmaceutical products of Boehringer Ingelheim Animal Health. Additionally, the incumbent will perform routine and non-routine testing related to investigational samples. The individual is expected to work under GMP and serve as an analytical project leader, as appropriate.
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 directly contribute 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
+ With Minimum guidance from a more senior staff member develops, validates, and transfers robust analytical methods for testing of raw materials, excipients, APIs and finished products to BI QC labs and to the QC labs of CMO.
+ Perform routine and non-routine testing related to investigational samples.
+ Records, evaluates, interprets and summarizes technical data.
+ Perform instrument troubleshooting.
+ Prepare protocols, memos, reports, and regulatory documents
+ Acts as a Principal Investigator if needed.
+ Able to deliver results for multi tasks and work in a team environment to meet business needs.
+ Organizes and presents the results of work internally and externally.
+ Functions as in-house consultant for areas of technical expertise and provide technical supervision to junior scientist as needed.
+ Provides technical expertise in planning, execution of planned experiments, monitoring, and maintaining project timelines to meet business needs.
+ Reports and treats data with a high level of integrity and ethics.
+ Understands and complies with applicable regulations, performing all work in a safe manner; maintains proper records in accordance with Standard Operating Procedures (SOPs) and policies.
+ Participate in cross departmental project teams when assigned.
Requirements
+ PhD from an accredited institution in Analytical Chemistry (preferably on Separation Sciences Techniques) or related field of Chemistry.
+ Knowledge and experience on Analytical Chemistry on various Techniques/Technologies, preferably in the area of Separation Sciences Techniques, and or related fields such as Physical Organic Chemistry, Physical Chemistry and or other related fields.
+ Expertise in separation sciences techniques and other state-of-the-art analytical techniques and technologies.
+ Knowledge of cGMP regulations, ICH/VICH guidelines, and compendia monographs/methods is preferred.
+ Good ability to work with others to accomplish project goals.
+ Plan and conduct scientific/laboratory experiments, evaluate and interpret data.
+ Provide training and guidance to junior laboratory personnel.
+ Prepare technical reports, publications and oral presentations.
+ Possesses in-depth knowledge and thorough understanding of USFDA, EMEA and other health regulatory requirements.
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.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Under the general guidance of a more senior staff member or Head of the department, the incumbent is responsible for developing, validating and transferring robust analytical methods to support testing of APIs, excipients, raw materials and finished products related to marketed/commercial global pharmaceutical products of Boehringer Ingelheim Animal Health. Additionally, the incumbent will perform routine and non-routine testing related to investigational samples. The individual is expected to work under GMP and serve as an analytical project leader, as appropriate.
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 directly contribute 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
+ With Minimum guidance from a more senior staff member develops, validates, and transfers robust analytical methods for testing of raw materials, excipients, APIs and finished products to BI QC labs and to the QC labs of CMO.
+ Perform routine and non-routine testing related to investigational samples.
+ Records, evaluates, interprets and summarizes technical data.
+ Perform instrument troubleshooting.
+ Prepare protocols, memos, reports, and regulatory documents
+ Acts as a Principal Investigator if needed.
+ Able to deliver results for multi tasks and work in a team environment to meet business needs.
+ Organizes and presents the results of work internally and externally.
+ Functions as in-house consultant for areas of technical expertise and provide technical supervision to junior scientist as needed.
+ Provides technical expertise in planning, execution of planned experiments, monitoring, and maintaining project timelines to meet business needs.
+ Reports and treats data with a high level of integrity and ethics.
+ Understands and complies with applicable regulations, performing all work in a safe manner; maintains proper records in accordance with Standard Operating Procedures (SOPs) and policies.
+ Participate in cross departmental project teams when assigned.
Requirements
+ PhD from an accredited institution in Analytical Chemistry (preferably on Separation Sciences Techniques) or related field of Chemistry.
+ Knowledge and experience on Analytical Chemistry on various Techniques/Technologies, preferably in the area of Separation Sciences Techniques, and or related fields such as Physical Organic Chemistry, Physical Chemistry and or other related fields.
+ Expertise in separation sciences techniques and other state-of-the-art analytical techniques and technologies.
+ Knowledge of cGMP regulations, ICH/VICH guidelines, and compendia monographs/methods is preferred.
+ Good ability to work with others to accomplish project goals.
+ Plan and conduct scientific/laboratory experiments, evaluate and interpret data.
+ Provide training and guidance to junior laboratory personnel.
+ Prepare technical reports, publications and oral presentations.
+ Possesses in-depth knowledge and thorough understanding of USFDA, EMEA and other health regulatory requirements.
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.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Source : Boehringer Ingelheim