Boehringer Ingelheim Scientist II,/III Bio QC in SAINT JOSEPH, Missouri

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.

Description:

The Bio Quality Control group is responsible for performing bio-analytical methods (immunological, in vivo, microbiological, molecular biological, or virological) for various Bio QC tests on raw materials, in-process, release or stability samples in compliance with 9CFR, EU and VICH regulatory guidelines, Outlines of Production and Special Outlines. The incumbent will initiate, execute and complete assays as per validated procedures and within Quality and Compliance guidelines. The incumbent is responsible for timely communication with supervisors to inform them of testing, compliance and/or scheduling issues, adhering to company policies, maintaining a safe work environment through Site safety KPIs, living out the Lead & Learn principles and following appropriate GMP documentation. Additional duties are based up the incumbents level.

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

  • Testing

  • Perform testing using a portion of the existing laboratory assays

  • Perform testing using a significant portion of the existing laboratory assays

  • Maintains laboratory reagents, supplies and calibrated equipment

  • Prepare reagents and materials

  • Calculates results

  • Communicates schedule, test status and concerns

  • Write Laboratory Investigations, as needed.

  • Review and approve results and test sheets

  • Revise a Pre-existing Standard Methods and SOPs

  • Create New Standard Methods, SOPs, Protocols

  • Trains others on methods & procedures

  • Support

  • Plans activities and structures work for others

  • Prepares work schedule for self

  • Uses data analysis to make decisions and recommendations

  • Coordinates and participates in assay validation

  • Coordinates and participates in assay transfers

  • Projects

  • In house reagent replacement / validation

  • Coordinate projects with supervision

  • Coordination of projects within group

  • Coordination of projects within department

  • Coordination of projects between departments

  • Writes reports and summaries

  • Is called upon by other groups in QC for collaboration or SME

  • Is called upon by other departments for collaboration or SME

  • Skills

  • Information/data summarized in concise format

  • Represent department at meetings

  • Demonstrates creativity and contributes original suggestions

  • Troubleshoot/Problem solving beyond method defined action

  • Locate answers from other areas/consult with other areas

  • Seeks development opportunities

  • Technology

  • Use of Word and Excel

  • Use of QM software for data management (LIMS) and use of MRP inventory software

  • Use of deviation software (Trackwise) and monitoring software (PDCS)

  • Use of IDEA for Con (Document system)

  • Use of IDEA for Sub (Document submission system)

Scientist II Requirements:

  • Bachelor’s degree in a relevant scientific discipline required plus four (4) to eight (8) years relevant experience preferred, or

  • Master’s degree in a relevant scientific discipline, relevant industry plus two (2) to four (4) years of relevant experience preferred

  • Through understanding of scientific concepts and principles and complex lab techniques.

  • Able to manage portions of major projects with supervision or minor projects independently.

  • Develop/validate methods and processes.

  • Performs and documents work following established methods, SOP’s and/or GXP.

  • Good understanding of applicable regulations and impact to project and/or business.

  • Able to interact with regulatory agencies.

  • Comprehensive understanding of processes in immediate area and familiarity of processes in other areas.

  • Makes routine decisions with limited guidance from supervisor.

  • Recognizes and reacts to the significance of data/results.

  • Able to effectively communicate procedures, thoughts and ideas in a clear concise and appropriate manner within and outside of own department.

  • Communicates with cross-functional groups.

  • Documents and reviews lab results/data as required by applicable SOP’s and methods.

  • Organizes data generated for inclusion in reports.

  • Write and revise SOP’s, methods, and protocols.

  • Works and interacts mainly within own group to complete tasks assigned.

  • Able to train others on methods and routine lab work.

  • Cooperates and shares information with other groups and departments to accomplish goals.

  • Contributes original suggestions and acts independently to find answers and solutions.

Scientist III Requirements:

  • Bachelors’ degree in a relevant scientific discipline required plus eight (8) to twelve (12) years of relevant experience preferred, or

  • Master’s degree in a relevant scientific discipline, relevant industry plus four (4) to eight (8) years of relevant experience preferred, or

  • PhD in a relevant scientific discipline, relevant experience preferred

  • Through understanding of scientific concepts and principles and complex lab techniques.

  • Able to manage portions of major projects with supervision or minor projects independently.

  • Develop/validate methods and processes.

  • Performs and documents work following established methods, SOP’s and/or GXP.

  • Good understanding of applicable regulations and impact to project and/or business.

  • Able to interact with regulatory agencies.

  • Comprehensive understanding of processes in immediate area and familiarity of processes in other areas.

  • Makes routine decisions with limited guidance from supervisor.

  • Recognizes and reacts to the significance of data/results.

  • Able to effectively communicate procedures, thoughts and ideas in a clear concise and appropriate manner within and outside of own department.

  • Communicates with cross-functional groups.

  • Documents and reviews lab results/data as required by applicable SOP’s and methods.

  • Organizes data generated for inclusion in reports.

  • Write and revise SOP’s, methods, and protocols.

  • Able to train others on methods and routine lab work.

  • Cooperates and shares information with other groups and departments to accomplish goals.

  • Contributes original suggestions and acts independently to find answers and solutions.

  • Thorough understanding of scientific concepts and principles and complex lab techniques including aseptic technique.

  • Trend different types of data (EM and process) in order to provide timely reports.

  • Physical Demands / Surroundings:

  • Lifting, carrying, pushing or pulling up to 50 pounds occasionally

  • Frequent periods of sitting, walking, and standing

  • Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat

  • Occasional low level work, fine finger dexterity/ including grasping or pinching required

  • Writing and use of a computer keyboard frequently

  • Occasional use of personal protective equipment

  • Visual / Hearing Demands: Color vision and depth perception required. May require extended hours at a computer screen. Must be able to read electronic documents of all types. Hearing acuity required.

Eligibility Requirements:

  • Must be legallyauthorized to work in the United States without restriction.

  • Must be willing totake a drug test and post-offer physical (if required)

  • Must be 18 years ofage or older

Our Culture:

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-Vetmedica

Title: Scientist II,/III Bio QC

Location: Americas-United States-MO-Saint Joseph

Requisition ID: 185849