Scientist III, Bio QC Full-time

Job Title

Scientist III, Bio Quality Control

Job Description

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 several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

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 Scientist III, Bio Quality Control 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.

Duties & Responsibilities

Testing:

• Performs testing using a portion of the existing laboratory assays.
• Performs testing using a significant portion of the existing laboratory assays.
• Maintains laboratory reagents, supplies and calibrated equipment.
• Prepares reagents and materials.
• Calculates results.
• Communicates schedule, test status and concerns.
• Writes Laboratory Investigations, as needed.
• Reviews and approve results and test sheets.
• Revises a Pre-existing Standard Methods and SOPs.
• Creates 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.
• Coordinates projects with supervision.
• Coordinates projects within group.
• Coordinates projects within department.
• Coordinates 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:

• Ensures information/data is summarized in concise format.
• Represents department at meetings.
• Demonstrates creativity and contributes original suggestions.
• Troubleshoots/problem solves beyond method defined action.
• Locates answers from other areas/consult with other areas.
• Seeks development opportunities.

Requirements

• BS in a relevant scientific discipline required with eight to twelve (8-12) years of relevant experience preferred.

OR

• MS in a relevant scientific discipline, relevant industry with four to eight (4-8) 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) to provide timely reports.

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).

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.

Desired Skills, Experience and Abilities