Adherence 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
Job: Manager, QC
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.
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 quality
Supports 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 improvement
Encourage 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:
Minimum of an Associate's degree.
Bachelor's degree in science related field is a plus but not required.
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 Improvement
Quality 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 Standards
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
