Scientist II, Bio QC

Description

Incumbent 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. 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, 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
• Leadership/Communication
  • Lead, train, direct junior Scientists within the team. Responsible for timely communication with peers, leaders and relevant stakeholders (including cross-functionally) to inform them of testing, compliance and/or scheduling issues, adhering to company policies, maintaining a safe work environment. through Site safety KPIs and following appropriate GMP documentation.

Requirements

• Bachelors degree in Biology or a relevant scientific discipline.
• In addition to Bachelors degree, a minimum of 4 years relevant scientific and/or animal care experience in a cGMP or similar environment. Or, Associates degree and a minimum of 6 years relevant scientific and/or animal care experience in a cGMP or similar environment. Ability to use Word & Excel; SAP system for test reporting and inventory availability of media; GoTrack system for OOX, CAPA and deviation reporting and investigations; Trackwise system for document creations/revisions and reports; IDEA for Con system for document creations/revisions and reports; and site testing equipment.

Desired Skills, Experience and Abilities