Master/Specialist/Senior Specialist, QC Lab General

Company: Boehringer Ingelheim
Location: Fremont
Posted on: July 31, 2022

Job Description:

Description:

Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim s Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.

We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs.

Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheim s unique experience of having brought 30+ biologics to market globally.

Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.

Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients!

Description:





Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Raw Materials/Cleaning validation/verification. Performs duties under limited supervision and according to standard operating and QC procedures. Technical and Quality lead for non-routine, new method transfer / validations / qualifications, verifications and technical assessments. Responsible for quality and compliance activities including new test methods, specs, plans, reports, forms, SOPs, etc. with no previous experience within the department. Group representative on equipment qualifications for new and novel technology. Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new equipment validation. Identifies and implements novel improvements and new ways of thinking toward lab processes and compliance activities. Cross functional project team lead responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls) with impact across multiple functional areas in the QC department. Serves as a QC subject matter expert (SME) representing the department during audits for critical processes with impact across multiple functional areas in the QC department. Represents team on global team initiatives and external facing client teams. Project leader of non-routine, new initiatives with local cross functional impact. Establishes training curricula and train others as a SME. Establishes timelines, sets goals and implements strategy for site wide QC projects.

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:

• Technical and Quality lead for non-routine, new method transfer/validations/qualifications, verifications and technical assessments. Group representative on equipment qualifications for new and novel technology. Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new method equipment validation.
• Identifies and implements novel improvements and new ways of thinking toward lab processes and compliance activities. Responsible for quality and compliance activities including new test methods, specs, plans, reports, forms, SOPs, etc. with no previous experience within the department. Cross functional project team lead responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls) with impact across multiple functional areas in the QC department. Serves as a QC subject matter expert (SME) representing the department during audits for critical processes with impact across multiple functional areas in the QC department.
• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Represents team on global team initiatives and external facing client teams. Project leader of non-routine, new initiatives with local cross functional impact. Establishes timelines, sets goals and implements strategy for site wide QC projects.
• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Conducts group trainings on complex topics and scientific principles as needed. Establishes training curricula and train others as a SME. Implements new training procedures and drives continuous improvement. Improves cross training and coaches others.
• Leads OOX and OOE investigations.
• Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place.
• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results. Influences and leads inter-departmental meetings with cross functional managers to resolve issues and produce solutions.
• Manages deviation investigations as applicable and provides product quality impact assessment.
• Leads complex deviation investigations as applicable and provides product quality impact assessment.
• Responsible for training others. Master Associate Requirements:
  • Bachelors degree from an accredited institution in a science or engineering related field, with four (4) years of experience in cGMP regulated industry or equivalent; Or
  • Masters degree from an accredited institution in a science or engineering related field, with one (1) years of experience in cGMP regulated industry or equivalent.
  • Proven experience with technical review, analysis and interpretation of scientific data.
  • Experience with computer-based systems and ideally experience with process control systems.
  • Previous experience authoring SOPs, methods, and/or work instructions and document work in a written format applying cGMP/GDP standards.
  • Subject matter expert in performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing. Specialist Requirements:
    • BS/BA from an accredited institution in a science or engineering related field, with four (4) years of work experience in analytical testing in a GMP regulated industry or equivalent; Or
    • MS/MA from an accredited institution in a science or engineering related field, with two (2) years of work experience in Analytical testing in a GMP regulated industry or equivalent.
    • Proven experience with technical review, analysis and interpretation of scientific data.
    • Experience with computer-based systems and ideally experience with process control systems.
    • Previous experience authoring SOPs, methods, and/or work instructions.
    • Experience interacting with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise. Sr. Specialist Requirements:
      
      
      
      
      • Bachelors Degree in a science or engineering related field from an accredited institution, with six (6) years of experience in analytical testing in a GMP regulated industry or equivalent; Or
      • Masters Degree in a science or engineering related field from an accredited institution, with four (4) years of experience in analytical testing in a GMP regulated industry or equivalent: Or
      • PhD in a science or engineering related field from an accredited institution, with two (2) years of experience in analytical testing in a GMP regulated industry or equivalent. PhD preferred.
      • Proven experience with technical review, analysis and interpretation of scientific data.
      • Experience with computer-based systems and ideally experience with process control systems.
      • Previous experience authoring SOPs, methods, and/or work instructions.
      • Experience providing oral and poster presentations on complex technical problems to other scientific experts.
      • Subject matter expert in performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing...... click apply for full job details

Keywords: Boehringer Ingelheim, Fremont , Master/Specialist/Senior Specialist, QC Lab General, Healthcare , Fremont, California