Thermo Fisher Scientific
Manager, QC
Thermo Fisher Scientific, St Louis, Missouri, United States,
Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
QC Chemistry Manager
At Thermo Fisher Scientific, each one of our extraordinary minds has a unique story to tell. Join us and contribute to our singular mission - enabling our customers to make the world healthier, cleaner and safer.
When you're part of Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world!
Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by the FDA, EMA and other regulatory agencies as applicable. To achieve compliance, quality systems are defined, implemented and maintained. We are responsible for ensuring the completion of qualification/validation protocols, batch release and stability testing. We are a quickly expanding site with ever growing opportunities. We believe our workforce are our greatest asset and are passionate about cultivating and developing future talent! The QC Manager will lead the Quality Control Chemistry team, consisting of roles:Quality Control Scientist/s (Engineer/Scientists I, II, & III)Senior Quality Control Technician/s
Key Responsibilities:
Responsibilities include assuring timely and scientifically sound output for the Quality Control Chemistry team according to international regulatory guidelines related to assay qualification/validation, in-process production samples, final formulated products and systems, and in line with the customer specific requirements.The QC Manager is responsible for day-to-day management of the laboratory team of 6-8 employees, including planning of activities and resources, execution of analysis, and reporting of results.The QC Manager is tasked with oversight of sophisticated biological and physical characterization techniques (but not limited to): capillary electrophoresis (cIEF/ICE, CE-SDS), UPLC/HPLC (excipient quantification, glycan analysis, proteolytic mapping, IEX, SEC)Establishes the goals and objectives of employees, ensuring a high level of analytical qualitySupports customer focused outcomes for the analysis of stability study samples, method analytical transfer, and qualification and validation studies to agreed timelines.Supporting PSG St. Louis' Engineering Team on equipment maintenance and calibration.Assisting the Engineering and Validation Team with equipment/system upgrades and qualification.Assisting with the revenue deliverables of the Company through analytical chemistry outcomes and the release of drug substance (DS) results.Peer review and technical review of analyses for completeness and cGMP compliance.Seeks improvement through effective key performance indicators, targets and goal setting.Strong engagement to lead and promote continuous improvementEncourage and mentor members of the team.Transferring new analytical techniques and assays into the Chemistry Laboratory.Monitors new technologies which are relevant to the QC department that may offer more cost effective and robust solutions for the company.Assist with regulatory and client audits, representing all aspects of the QC Chemistry Team.Ensures scientific integrity is maintained, working closely with the data integrity officer.Facilitates atypical, out of specification or out of trend investigations with the team to ensure swift resolution,Selects, develops, and evaluates staff to ensure the efficient operation of each QC Chemistry activity.Practical application of various risk assessments tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and an ability to directly develop, participate, and mentors on the appropriate and efficient application of these processes.Adherence to Quality Systems related including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management.
Required Qualifications:
Bachelor of Science (Biotechnology, Chemistry, or closely related degree). Post Graduate qualifications - beneficial.Minimum of 1 year experience in a leadership role. 5 years' experience in the pharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields, especially in chromatography analysis.
Preferred Qualifications:
Expertise with method transfer and qualification or validation.Knowledgeable in cGMP practices.Strong background in analytical theory and technical competency with laboratory analysis.Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives, working on multiple projects simultaneously.Strong team-working and collaborative skills.Expertise with Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint), Laboratory Information Management Systems (LIMS), Empower, 32 Karat, Smartsheets.Provide industry-leading customer experience.Deliver the best technical and scientific solutions to enhance product value.Build a culture of engagement, accountability and a shared commitment to excellence.Abide by all EH&S policies and procedures. Work safely and only perform tasks if currently proficient and/or authorized, participate in EH&S activities such as GEMBA walks, inspections, and risk assessments.
Knowledge, Skills & Abilities:
Adaptability: Ability to adapt to daily business requirements.Collaborating: You will have the ability and proficiency to engage across departments and colleagues of varied backgrounds.Continuous ImprovementQuality Orientation: Ability to interpret and apply cGMP and ICH principles as they pertain to laboratory operations, strong attention to detail, and accurate completion of test records. Strives for right first time in every task undertaken.
Work Conditions:
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsSome degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Will work with hazardous/toxic materials
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
QC Chemistry Manager
At Thermo Fisher Scientific, each one of our extraordinary minds has a unique story to tell. Join us and contribute to our singular mission - enabling our customers to make the world healthier, cleaner and safer.
When you're part of Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world!
Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by the FDA, EMA and other regulatory agencies as applicable. To achieve compliance, quality systems are defined, implemented and maintained. We are responsible for ensuring the completion of qualification/validation protocols, batch release and stability testing. We are a quickly expanding site with ever growing opportunities. We believe our workforce are our greatest asset and are passionate about cultivating and developing future talent! The QC Manager will lead the Quality Control Chemistry team, consisting of roles:Quality Control Scientist/s (Engineer/Scientists I, II, & III)Senior Quality Control Technician/s
Key Responsibilities:
Responsibilities include assuring timely and scientifically sound output for the Quality Control Chemistry team according to international regulatory guidelines related to assay qualification/validation, in-process production samples, final formulated products and systems, and in line with the customer specific requirements.The QC Manager is responsible for day-to-day management of the laboratory team of 6-8 employees, including planning of activities and resources, execution of analysis, and reporting of results.The QC Manager is tasked with oversight of sophisticated biological and physical characterization techniques (but not limited to): capillary electrophoresis (cIEF/ICE, CE-SDS), UPLC/HPLC (excipient quantification, glycan analysis, proteolytic mapping, IEX, SEC)Establishes the goals and objectives of employees, ensuring a high level of analytical qualitySupports customer focused outcomes for the analysis of stability study samples, method analytical transfer, and qualification and validation studies to agreed timelines.Supporting PSG St. Louis' Engineering Team on equipment maintenance and calibration.Assisting the Engineering and Validation Team with equipment/system upgrades and qualification.Assisting with the revenue deliverables of the Company through analytical chemistry outcomes and the release of drug substance (DS) results.Peer review and technical review of analyses for completeness and cGMP compliance.Seeks improvement through effective key performance indicators, targets and goal setting.Strong engagement to lead and promote continuous improvementEncourage and mentor members of the team.Transferring new analytical techniques and assays into the Chemistry Laboratory.Monitors new technologies which are relevant to the QC department that may offer more cost effective and robust solutions for the company.Assist with regulatory and client audits, representing all aspects of the QC Chemistry Team.Ensures scientific integrity is maintained, working closely with the data integrity officer.Facilitates atypical, out of specification or out of trend investigations with the team to ensure swift resolution,Selects, develops, and evaluates staff to ensure the efficient operation of each QC Chemistry activity.Practical application of various risk assessments tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and an ability to directly develop, participate, and mentors on the appropriate and efficient application of these processes.Adherence to Quality Systems related including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management.
Required Qualifications:
Bachelor of Science (Biotechnology, Chemistry, or closely related degree). Post Graduate qualifications - beneficial.Minimum of 1 year experience in a leadership role. 5 years' experience in the pharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields, especially in chromatography analysis.
Preferred Qualifications:
Expertise with method transfer and qualification or validation.Knowledgeable in cGMP practices.Strong background in analytical theory and technical competency with laboratory analysis.Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives, working on multiple projects simultaneously.Strong team-working and collaborative skills.Expertise with Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint), Laboratory Information Management Systems (LIMS), Empower, 32 Karat, Smartsheets.Provide industry-leading customer experience.Deliver the best technical and scientific solutions to enhance product value.Build a culture of engagement, accountability and a shared commitment to excellence.Abide by all EH&S policies and procedures. Work safely and only perform tasks if currently proficient and/or authorized, participate in EH&S activities such as GEMBA walks, inspections, and risk assessments.
Knowledge, Skills & Abilities:
Adaptability: Ability to adapt to daily business requirements.Collaborating: You will have the ability and proficiency to engage across departments and colleagues of varied backgrounds.Continuous ImprovementQuality Orientation: Ability to interpret and apply cGMP and ICH principles as they pertain to laboratory operations, strong attention to detail, and accurate completion of test records. Strives for right first time in every task undertaken.
Work Conditions:
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsSome degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Will work with hazardous/toxic materials
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.