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

BoehringerPRD•Fremont, CA

18d

About The Position

This role involves performing duties within a QC functional or technical area such as HPLC/CE, Potency testing, Residual Impurities, Physicochemical/Drug Product, or Raw Materials/Cleaning validation/verification. The employee will work under limited supervision, adhering to standard operating and QC procedures. This position serves as a scientific and quality lead for implementing novel methodologies and technologies within the site and global network. The role involves being a group representative on new or complex equipment qualifications impacting global QC systems, and acting as a team lead responsible for quality risk assessment, onboarding, qualification, and implementation of non-routine, new equipment validation. The individual will be a QC subject matter expert (SME) for critical processes with interdisciplinary impact, and a change agent accountable for identifying novel processes or approaches to improve QC methods or compliance. Responsibilities include concept design, strategy, and implementation of novel processes and technologies. The role also involves leading cross-functional teams to handle complex deviations, OOS, investigations, CAPAs, and change controls impacting multiple departments. The individual will lead global team initiatives and external-facing client teams, and author regulatory documents. They will establish timelines, set goals, and develop/implement strategy for cross-site and global QC initiatives, while also improving cross-training, coaching, and mentoring others. The position may also serve as a backup to Sr. Manager or Associate Director/Sr. Associate Director roles. The company, Boehringer Ingelheim, emphasizes employee contribution to product discovery, development, and delivery, offering opportunities for international collaboration and visibility. They support employees through a healthy working environment, meaningful work, mobility, networking, and work-life balance, with competitive compensation and benefit programs.

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.
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.
Previous experience authoring SOPs, methods, and/or work instructions.
Track record of troubleshooting and applying the scientific method to solve technical problems.
Skills in Quality Systems (CAPA, CC, Deviations, OOX, etc.).
Demonstrated ability to lead cross functional projects of moderate complexity.
Proven track record to mentor, train and lead others within discipline.
Able to lead/direct/manage multiple projects, influencing stakeholders and tracking milestones for timely delivery.

Nice To Haves

PhD preferred.

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.
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.
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.
Implements new training procedures and drives continuous improvement.
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.
Responsible for training others.
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