Boehringer Ingelheim Scientist IV, NCE Preclinical Analysis - MAS in RIDGEFIELD, Connecticut
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Scientist IV, NCE Preclinical Analysis - MAS
Design and executes non-routine experiments on the basis of literature analyses, technical expertise and compliant with GLP regulations, generally without supervision. Train technicians and junior scientist in all areas of laboratory operations. Perform all work in conformance with FDA/GLP regulations. Assume responsibilities for regulatory roles as required in support of nonclinical GLP Studies. Perform all work in a safe manner. Must have the ability to communicate effectively and work in a multi-disciplinary environment with internal and external business partners, as needed.
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
Dutiesand Responsibilities :
Serves as an experienced analytical scientist tosupport Nonclinical Drug Safety studies.Responsible for supporting daily activities in the NCE PreclinicalAnalysis Laboratory.Ensures that allassigned work packages meet timelines.
Independently performs HPLC analytical methoddevelopment and validation in support of dose formulation analysis required forGLP nonclinical studies.Provide analytical support for doseformulation analysis as well as for non-routine tasks including formulationdevelopment activities.
Serve as Contributing Scientist/Principal Investigator(analytical expert) in support of GLP nonclinical studies and as Study Directorfor GLP Dose Formulation Stability studies. Writes supporting protocols andtechnical reports.
Writes or revises SOPs to document procedures and workprocesses as needed. Designs and enacts improvements to streamline workprocesses in the laboratory.
Documents and records data according to applicable regulatory guidelines(GLP/FDA Regulations) by following study protocols, company compliance andsafety policies and SOPS.Maintainsproper records in accordance with GLPs, SOPs and policies.
Performs literature searches, maintain high level ofexpertise, learn and utilize new techniques to enhance developmentcapabilities; communicate progress via technical reports, presentationsinternally and at scientific meetings and publications.
Communicateseffectively orally and in writing. Ability to easily interface with internal businesspartners (including quality assurance) and external customers (includingcontract research organizations) in support of nonclinical studies.
Canassume responsibility of laboratory operations and represent NCE PA, as needed,in the absence of the laboratory supervisor. Ability to train other scientistson new techniques.
RequiredEducation and Experience :
Master’s Degree from an accredited institution withsix-plus (6+) years of experience in a related scientific discipline, orBachelor’s Degree from an accredited institution with 10+ years of experiencein a related field or equivalent experience in a related field
Knowledge of analytical chemistry. Proficient inmethod development and validation using various analytical techniques (such asHPLC); Proficient with Waters Empower 3 and interpret chromatographic data.Ability to implement new experimental designs,strategies, explore new technologies, and conduct probing experiments.
Knowledgeand understanding of applicable regulatory guidelines (e.g., GLP/FDARegulations).
Abilityto independently troubleshoot, analyze and interpret own experiments.
Conciseand accurate reporting of technical data and information for nonclinical studyreports. Proficient in peer review, attention to detail, and controlleddocument management systems.
Goodcommunications skills and interpersonal skills and ability to perform in a teamenvironment.
Mustbe legally authorized to work in the United States without restriction.
Mustbe willing to take a drug test and post-offer physical (if required)
Mustbe 18 years of age or older
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-BI Pharma/BI USA
Title: Scientist IV, NCE Preclinical Analysis - MAS
Location: Americas-United States-CT-Ridgefield
Requisition ID: 189091