Senior Associate, AD
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Senior Research Associate performs GMP testing in support of manufacturing which includes environmental monitoring testing, utilities monitoring testing, inspection and release testing of raw materials and packaging components as per USP/EP compendial test methods and standard test methods. The Senior Research Associate also performs GMP testing as required to support of release and stability of API and finished drug product. He/She maintains laboratory cleanliness and performs preventative maintenance on laboratory equipment per established procedures.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Performs duties in support of QC Laboratory operations such as facilities qualification and routine environment and utilities monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified
• Perform identification, assay and limit testing of raw materials to support GMP manufacturing requirements. Common analysis techniques include analytical balance, FTIR, pH measurement, UV-VIS spectrophotometer, osmometer, and manual titrations.
• Sample and inspect raw materials in compliance with GMP/ANSI standards.
• performs GMP testing as required to support of release and stability of API and finished drug product. Common analysis techniques include ELISA assay, BCA assay, HPLC, SDS-Page, Western Blot.
• Authors specifications, SOPs, and method verification protocols and reports
• Ships samples and monitors test results produced by contract testing laboratories
• Performs required data analysis, compiles data, and prepares results for review
• Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.
• Present data to communicate findings to internal groups and management
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.
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
• Ability to follow SOPs and comply with cGMPs; generate SOPs
• Familiarity with global pharmacopeias and monograph testing
• Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics
• Requires experience with executing 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
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.