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
A technical leader in the QC Laboratory Services group. Lead or participate in the selection, procurement and commissioning of equipment process. The SME for enterprise-wide solutions and lead the introduction of new technology into the business unit. Performs calibration activities. Participates in technical writing and execution of technical protocols and writing reports. Perform analytical testing per cGMP in support new technology and existing products. Typical hours are 8:00am – 4:30pm, Monday through Friday. Hours may vary to meet business and training needs.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• SME in equipment selection, procurement and commissioning; including authoring CAPEXes, change controls, SOPs, etc. as needed for Analytical/Micro.
• SME for global/enterprise solutions; e.g., LIMS and Empower3. Includes attending meeting, discussions and training as it pertains to the laboratory and completing project- oriented tasks.
• Independently coordinate complex activities such as calibration and preventative maintenance activities.
• Manage change controls and change control tasks.
• Authors and/or reviews technical documents as SME such as IOQ documents, calibration data, technical protocol/reports, Data Integrity reports, etc.
• Leads troubleshooting various types of equipment including proactive resolution of instrument issues.
• Assess the compliance status of current test methods/equipment, coordinate and execute testing to ensure various methods/equipment are meeting current industry standards.
• Conduct training sessions for new protocol and standard operating procedures, mentoring Laboratory Technicians, Assistant and Associate Scientists to develop laboratory core competencies.
• Perform various analytical testing procedures as per manufacturing/Quality Control batch records, Stability Protocols, etc.; including but not limited to instrumental analysis such as Karl Fischer, UV, HPLC and Gas chromatography.
• Executes complex methods requiring difficult sample preparation or data analysis.
• Assist with design of method validations, executes validation studies including method transfer activities.
• Reviews/approves batch records (engineering, media fills, master production control records) for the laboratories.
• Reviews raw data for the laboratories, including batch records, components, raw material data packets, and LIMS data.
• Perform final review of calculations, logbooks and other data, including batch records, protocols and reports.
• Writes deviations and assists with testing plans as needed.
• Assists with closing CAPAs and Client Observations.
• Assist or author OOS and/or OOL investigations, deviations, and testing plans as needed.
• Authors and reviews SOPs, Test Methods, and Specifications.
• Assist with client or regulatory tours of the laboratories.
• Assist with the validation of system improvements (drafting user requirements, PQ protocols, and execution of protocols).
• Review developmental/qualification/validation protocols.
• Organizing meetings and/or training related to projects.
• Represent the QC Laboratory department at cross-functional meetings
• Interact with clients as necessary regarding CGMP, tech transfer methods, or stability issues
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Support department compliance and productivity goals.
• Participation in biomedical monitoring required.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Education and Experience: A minimum of a B.S. in Chemistry, Biochemistry or related scientific discipline with a minimum of 7 years’ experience.
Must have sound scientific background in analytical chemistry and typical applications. Must have experience in and demonstrate broad knowledge in validation and/or transfer, assay/impurity analysis, specification development, and new analytical instrumentation commissioning. Must have experience in quality control change management.
Demonstrates knowledge and application of typical regulatory guidance such as cGMPs/GLPs, ICH, FDA, EMA, and CMC documents. Demonstrates knowledge and leadership in data integrity principles. Demonstrates knowledge of quality control regulatory requirements. Demonstrates leadership and mentorship across all quality control processes. Demonstrates proven leadership in department goals and independent management of projects. Expected to be familiar with CFR, USP, and Aseptic processing guidelines. Demonstrates solid communication and presentation skills. Demonstrates cross functional understanding and result-driven abilities.
Must be highly organized, detail oriented, and able to manage multiple projects and work with cross-discipline personnel. Must be capable of independent management of long-term projects. Expected to make independent decisions for near-term goal. Strong problem solving and root cause analysis skills. Strong analytical and strategic thinking skills are expected.
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.
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.