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
Perform methods and procedures for inspecting, testing, and evaluating raw materials. Support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other Emergent sites. Streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain quality control systems and activities. Conduct out-of-specification and failure investigations, recommend, and implement corrective actions. Responsible for generations, tracking, and completion of quality investigations and compliance records for the QC department.
II: ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Supports the implementation of the raw material program at EMOB.
• Leads change for revision of existing tests and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
• Assesses compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
• Perform daily activities in routine sampling raw materials, testing of raw materials and cleaning lab(weekly/monthly).
• Well versed in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, AKTA, HPLC and GC.
• Perform entering sample and result of raw materials into Lims Lab Vantage system.
• Communicate and coordinate with third parties and/or other departments.
• Prepares specifications, SOPs, and method verification protocols and reports.
• Ships samples and monitors test results produced by contract testing laboratories
• Communicates with raw material manufacturers to implement testing methodologies at EMOB.
• Perform daily activities in routine sampling raw materials, testing of raw materials and cleaning samples.
• Performs required data analysis, compiles data, and prepares results for review
• Conducts wet chemistry, chromatographic, and spectroscopic testing.
• Performs other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified.
• Supports raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
• Lead Period Review, OOS, deviations, Change Control, and CAPAs; designs and implements corrective action plans to address deficiencies.
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
• Bachelor’s Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master’s Degree with a minimum of 3 years of relevant experience. (Mainly QC Raw Material background)
• Experience with spectroscopic methods, chromatography, and wet chemistry methods.
• Familiarity with global pharmacopeias and monograph testing.
• Ability to follow SOPs and comply with cGMPs; generate SOPs.
• Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics.
• Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
• Requires the ability to execute raw material assay methodologies including spectroscopy, wet chemistry, and chromatography.
• Experience working in a pharmaceutical testing environment.
• Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff.
• Proficient in Microsoft Office - Word, Excel, PowerPoint.
• Comprehensive knowledge of pharmaceutical GLPs and GMPs.
• Comprehensive knowledge of laboratory techniques and safety precautions.
• Comprehensive knowledge of regulatory/industry guidance.
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.