Supervisor, Analytical (3rd Shift)
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I. JOB SUMMARY
Supervises the Quality Control, Analytical Services 3rd Shift. Responsible for maintaining a safe and professional work environment supporting raw material, component, in-process, final product and stability testing. Ensures on-time delivery of testing and key performance metrics for the second shift. Perform analytical testing per cGMP as needed to support shift operations. Typical hours are 10:30pm – 7:00am, Monday through Friday. Hours may vary to meet business and training needs and may include weekend work.
II. ESSENTIAL FUNCTIONS
• Supervises the QC Laboratory (Analytical) Services group in support of production by ensuring the timely release of manufacturing equipment, the water for injection system, raw materials, in-process and finished products.
• Reviews testing data and batch records (RM, FP, Stability, etc.) for accuracy and completeness and coordiantes their timely completion.
• Assists Analytical Services Manager in defining the activities of the Analytical Services laboratory to assure that all the test samples meet the raw materials, in-process and final products, and stability specifications.
• Serves as a resource of technical knowledge for established assays.
• Maintains schedules for analytical testing and stability testing that support corporate manufacturing schedules.
• Organize and oversee equipment release for production support.
• Assist Analytical Services Manager with all day-to-day production issues as they arise.
• Oversee CGMP work in lab, including, but not limited to stability testing, in-process and finished product testing.
• Ensure that all laboratory equipment, such as HPLC’s, UV’s, GC etc., are fully calibrated and validated.
• Assist all analytical personnel with troubleshooting, etc.
• Coordinate with other Departments such as Formulation, Production, Project Management, and QA to maintain corporate schedules.
• Assist in reviewing QC Batch Records before submission to QA.
• Write and review SOPs and Testing Standards as necessary
• Assist in writing protocols, reports, etc. as necessary.
• Inform Manager upon observing out of specification results.
• Leads investigations for in-process and finished product, stability, or other CGMP data.
• Trend deviation and OOS investigations and batch record turn around.
• Assist with managing CAPA system.
• Assist Method Validation in validation report generation and review.
• Participate in investigations and other related studies.
• Ensure the timely and cost-effective testing operations.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Provide data review as assigned.
• Track time worked per project.
• Train Analytical Services personnel.
• Represent Analytical Services in meeting with other departments and clients regarding cGMP, production, or stability issues.
Note: The responsibilities and tasks outlined in this Job Description are not exhaustive and may require other duties as determined by the needs of the department and company.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Education: A minimum of a B.S. in Chemistry or related field.
Experience: Minimum of 5 years of experience in a chemistry laboratory or equivalent. GLP/GMP experience is preferred. Empower, LIMS or SAP experience is preferred. Method development, improvement, or validation experience and chromatographic/biochemistry testing experience is preferred.
Knowledge: College and industry-level knowledge of general chemistry or biochemistry principles, math and writing skills are minimum requirements. Extensive technical expertise in analytical (chemistry) instrumentation and methods, including HPLC and GC in the Pharmaceutical industry. Must be able to proficiently apply knowledge to new and existing testing applications. Knowledgeable and resourceful with regulatory expectations, guidance and resources.
Skills: Can perform at an intermediate level of Excel and Word. Must possess knowledge of table building in Excel and formatting in Word. Must be able to write legibly and accurately and contemporaneously record work in written and/or electronic form.
Abilities: Effective verbal and/or written communication, the ability to complete daily tasks as assigned, the ability to improve processes, the ability to work independently and in a group, the ability to multi-task, and the ability to train on and learn computer-based programs and systems. Proven demonstration of qualifications related to Excel, Word, LIMS, or SAP systems is preferred, including course work.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
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Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.