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Sr Specialist/Principal Specialist, QC Lab General, Fremont CA

Boehringer Ingelheim

Fremont, CA

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JOB DETAILS
SKILLS
Analysis Skills, Analytical Method Validation, Assays, Biological Assay, Biotech and Pharmaceutical, Change Control, Coaching, Compensation and Benefits, Computer Skills, Continuous Improvement, Control Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Detail Oriented, Drug Products, Equipment Validation, GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), Identify Issues, Laboratory, Laboratory Information Management System (LIMS), Leadership, Manufacturing, Marketing Authorization Application (MAA), Medical Equipment, Mentoring, Multitasking, Onboarding, Patents, Presentation/Verbal Skills, Problem Solving Skills, Procedure Implementation, Process Control Engineering, Process Development, Process Improvement, Project/Program Management, Publications, Quality Assurance Methodology, Quality Control, Regulations, Risk Analysis, Root Cause Analysis, Safety Standards, Safety/Work Safety, Scientific Method, Scientific Principles, Set Goals, Standard Operating Procedures (SOP), Strategic Planning, Supply Chain, Team Lead/Manager, Team Player, Technical Analysis, Technical Leadership, Technical Presentation, Testing, Time Management, Training/Teaching, Training/Teaching Curriculum, Validation Testing, Writing Skills
LOCATION
Fremont, CA
POSTED
30+ days ago
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. Scientific and Quality lead for implementing novel methodologies and technologies within the site and global network. Group representative on new or complex equipment qualifications with impacts to global QC systems (e.g. Empower, LIMS, etc.). Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new equipment validation. Serves as a QC subject matter expert (SME) for critical processes with interdisciplinary impact on the site wide and global level. Change agent accountable for identification of novel processes or approaches that can improve QC methods or compliance. Responsible for concept design, strategy, and implementation of novel processes and technologies. Cross functional team lead that independently handles complex deviations, OOS, investigations, CAPAs and change controls that impact multiple departments including (but not limited to) manufacturing, E&T and supply chain. Independently leads global team initiatives and external facing client teams. Author of regulatory documents (IND/IMPD/BLA), briefing book updates and regulatory response questions. Establishes timelines, sets goals, develops and implements strategy for cross site and global QC initiatives. Improves cross training, coaches and mentors others. Serves as back up to Sr. Manager or Assoc. Dir./Sr. Assoc. Dir.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, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.


Principal Specialist, QC Lab General Duties & Responsibilities


+ Scientific and Quality lead for implementing new or novel methodologies and technologies within the site and global network. Group representative on new or complex equipment qualifications with impacts to global QC systems (e.g. Empower, LIMS, etc.). Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new equipment validation. Change agent accountable for identification of novel processes or approaches that can improve QC methods or compliance. Responsible for compliance concept design, strategy, and implementation of novel processes and technologies.

+ Cross functional team lead that independently handles complex, multi-faceted deviations, investigations, OOS, CAPAs and change controls that impact multiple departments including (but not limited to) manufacturing, E&T and supply chain. Serves as a QC subject matter expert (SME) for critical processes with interdisciplinary impact on the site wide and global level. Leads global team initiatives and external facing client teams.

+ 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.

+ Author of regulatory documents (IND/IMPD/BLA), briefing book updates and regulatory response questions.

+ 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. Improves cross training, coaches and mentors others. Establishes timelines, sets goals, develops and implements strategy for cross site and global QC initiatives. Serves as back up to Sr Manager or AD/Sr. AD.

+ Leads OOX and OOE investigations. Identifies protocol discrepancies and ensures they are properly defined, assessed and appropriate root causes are put in place. Influences and leads inter-site/business unit meetings with cross functional leaders to resolve issues and produce solutions. Quality and Technical leader for IND/IMPD and BLA/MAA sections related to analytical methods, validation, reference standards, justification of specifications, specifications, etc. Manages deviation investigations as applicable and provides product quality impact assessment. Leads complex deviation investigations as applicable and provides product quality impact assessment. Drives state of the art analytical techniques and methodology in the department. Recognized as site and business unit leader in QC analytical methods and processes.


Principal Specialist, QC Lab General Requirements


+ Bachelors degree from an accredited institution with ten (10) years of work experience in analytical testing in a GMP regulated industry or equivalent; Or

+ Masters degree from an accredited institution with seven (7) years of work experience in analytical testing in a GMP regulated industry or equivalent; Or

+ PhD from an accredited institution with three (3) years of 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.

+ Experience providing oral and poster presentations on complex technical problems to other scientific experts.

+ Demonstrated experience providing recommendations and proposals on scientific/technical topics to business leaders, steering committees, and/or clients.

+ Subject matter expert in performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing.

+ Expert in analytical methods, execute critical decision making, work independently with very little supervision, champions problem resolution, knows when to escalate to upper management, and provides compliant and smart solutions for complex validation issues.

+ Expert understanding of analytical methods and validation principles in pharmaceutical / biopharmaceutical / medical device industries.

+ Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.

+ Track record of participation in high performing teams and collaborate effectively with staff.

+ Ability to interact with auditors and regulators, clearly understand subject matter and concisely communicate within multiple areas of analytical techniques and quality matter expertise.

+ Proven capability to independently solve complex technical problems.

+ Demonstrated ability to lead complex projects involving matrix teams of different disciplines.

+ Proven ability to mentor, train and lead others within different scientific and technical disciplines.

+ Track record of publications, patents, manuscripts, or authoring of technical dossiers.


Sr Specialist, QC Lab General 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.


Sr Specialist, QC Lab General 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.

+ Expert in analytical methods, execute critical decision making, work independently with very little supervision, champions problem resolution, knows when to escalate to upper management, and provides compliant and smart solutions for complex validation issues.

+ Expert understanding of analytical methods and validation principles in pharmaceutical / biopharmaceutical / medical device industries.

+ Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.

+ Track record of troubleshooting and applying the scientific method to solve technical problems.

+ Skills in Quality Systems (CAPA, CC, Deviations, OOX, etc.).

+ Ability to work as part of a high performing team and collaborate effectively with staff.

+ Ability to interact with auditors and regulators, clearly understand subject matter and concisely communicate within areas of subject matter expertise.

+ Proven capability to independently solve complex technical problems.

+ Demonstrated ability to lead cross functional projects of moderate complexity.

+ Proven track record to mentor, train and lead others within discipline.


Desired Skills & Expectations


+ Able to lead/direct/manage multiple projects, influencing stakeholders and tracking milestones for timely delivery.

+ As QC delegate, able to independently assess impact of OOX’s/deviations and justify lot release decision.

+ Ability to recognize the need and when to escalate events/situations.

+ Driver of change with a “growth” mindset


This position offers a base salary typically between (75,000) and (122,000) OR ($115,000) and ($181,000).  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  Please reach out Talent Acquisition or your HR Business Partner for more information.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

About the Company

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Boehringer Ingelheim