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Manager, QC HPLC/CE at Boehringer Ingelheim

Manager, QC HPLC/CE

Boehringer Ingelheim Fremont, CA Full-Time

Description:

Description\:

Responsible for ensuring that the QC HPLC/CE group provides appropriate oversight over biopharma clinical and commercial GMP operations to ensure that products are tested to comply with the requirements of regulatory filings and do not place patients at risk due to inadequate safety, quality or efficacy.  Provides technical and compliance based direction to members of the group performing analytical testing of in-process products, or final products pre-release based upon sound scientific practice and general laboratory and company policies. Responsible for identifying and implementing novel improvements and new ways of thinking toward lab processes and compliance activities.

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\:

  • Coordinate day-to-day operations within lab to ensure materials and products are tested, reviewed and approved within the accepted time frames.  Interprets data and resolves technical issues for assays performed within the group (e.g., invalids, instrument investigation).  Ensures scientific and compliance based suitability of analytical methods used for testing materials and products through execution of method qualifications, method transfers, method validations, and data monitoring/trending.  Ensure compliance related to GMP testing against current regulations.  Identifies continuous process improvement areas.

  • Performs authorship or review of GMP documents, including deviations, change controls, SOPs, test methods, analytical investigations, and related technical protocols and reports.  Ensure compliance with current regulations.

  • Supervise, lead and manage technical employees. Ensure that training and other personal development programs are in place for succession planning and the development of subordinates.  Ensure that performance opportunities are pro-actively managed through the Performance Management system (SuccessFactors).

  • Provide leadership for analysts to optimize productivity and quality of work. Provide effective scheduling of analysts and equipment to support productivity and quality of work.

  • Conducts investigations related to OOS, unexpected results, or invalids of analysts within the group.  Ensure they are performed appropriately and within expected timeframes.  Ensure investigations are appropriately thorough to identify root causes or potential root causes and prevent recurrence.

  • Represents the QC HPLC/CE function at all cross-functional project team meetings, providing feedback to manager, project teams, and coordinating all QC activities both locally and across the network. Represents team on global initiatives and facing external client team. Provides key timeline and technical information to project teams on a routine basis. Actively share information, as appropriate, with direct reports.  Effectively communicate with manager, process engineers, and all stakeholders in other departments and sites.

  • Team lead responsible for the quality risk assessment, onboarding, qualification and implementation of non-routine, new method equipment validation.

  • Serves as the subject matter expert/Lead and actively participates in regulatory authority inspections and inspection readiness efforts.  Participates in authoring/reviewing of regulatory documents (IND/IMPD/BLA). Supports CMC regulatory submissions for pre-approval and post-approval activities, including Annual Reports and testing site transfers. 

  • 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 leading, coaching, and training analysts.

Requirements\:

  • BS/BA from an accredited institution in a science or engineering related field, with six (6) years of work experience in analytical testing in a  GMP regulated industry; Or

  • Masters Degree 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

  • A strong background in chromatography and electrophoresis technical skills is required.

  • Hands-on expertise in various HPLC modes (Size Exclusion, Ion Exchange, Affinity, Reversed-Phase, Oligossaccharide Map, Polysorbate, and Hydrophobic Ion Chromatography)and/or electrophoretic methods(reduced CGE, non-reduced CGE, cIEF) is required.  The required expertise is with respect to demonstrating theoretical understanding and providing effective analytical troubleshooting.

  • Experience and/or ability to provide analytical leadership such as troubleshooting is required.

  • Direct experience in method qualification, method transfer, and method validation in accordance with ICH guidelines is required. 

  • Knowledge of and the ability to implement CFR, and ICH requirements is required.

  • Knowledge of complex chromatography management systems and GMP documentation systems is required. Ability to implement and demonstrate testing in accordance 21CFR11 is required.

  • Drive to meet objective efficiently and on time in a fast pace environment.

  • Technical rigor, attention to details.

  • Proven capability to independently solve complex technical problems.

  • Learning agility, critical thinking and proven skill to integrate and synthesize information for devising solutions to technical questions.

  • Teamwork.

  • Leadership experience in leading a group of analysts to perform testing in accordance with cGMP principles is preferred.

  • Able to demonstrate the ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff.

  • Expert in analytical methods, execute critical decision making, lead and work with the analysts with very little supervision from manager, 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 industries.

  • Serves as Subject Matter Expertise having extensive technical knowledge on QC HPLC/CE analytical methods use for testing of intermediates and final products.

Desired Experience, Skills, and Abilities\:

  • Experience in conducting analytical investigations for Out of Specification or Out of Trend Results in accordance with regulatory guidelines is desired. 

  • Experience in trending analytical data (method data and product data) is preferred.

  • Direct experience in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems is desired.

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.

Who We Are\:

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. 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.

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RSRBI

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