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.
Conduct pre-formulation and formulation development studies for liquid, frozen and lyophilized drug products. Develop characterization methods and analytical test methods (content and/or purity by HPLC / UHPLC / CAD) for in-process, bulk drug product, and final drug product samples to establish product and process knowledge.
Optimize formulations and formulation processes to ensure superior stability and manufacturing feasibility under GMP conditions. Perform stability and characterization studies for R&D and clinical drug product samples. Determine leading formulations for clinical trials and support technology transfer of formulation processes to GMP manufacturing site.
Support interface with external clients / sponsors as well as Emergent functions such as analytical development, quality, upstream and downstream drug substance operations, and CMO manufacturing sites. Ensures work is completed within schedule and budget and in compliance with applicable Regulatory/Quality standards.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Utilizes broad knowledge and application of scientific theories and principles to resolve issues related to formulation and drug product manufacturing tasks.
• Develop HPLC / UHPLC assays to measure the content and purity of the active pharmaceutical ingredient, excipients, and adjuvants in the liquid, frozen, and lyophilized dry products.
• Develop physicochemical characterization assays and apply them at different stages of product development.
• Identify formulation matrices that ensure the stability of targeted biological and adjuvant molecules in liquid, frozen, and lyophilized drug products.
• Determine primary degradation pathways for biological and adjuvant molecules using chromatography-based methodology (HPLC / UHPLC / CAD / HPLC-MALS).
• Plan, perform and execute pre-formulation/formulation study, short and long-term stability and compatibility studies and experiments to support client product/process development projects, animal toxicity studies, CTM phase I/II/III studies and more.
• Establish, troubleshoot, and execute traditional and advanced formulation processes, including formulation/filtration/fill, nanoparticle formation, lyophilization
• Perform data analysis using appropriate statistical methods.
• Review and interpret data and present to immediate supervisor, team members, clients and upper management on regular basis.
• Prepare technical reports, regular project reports, presentations for internal and external audiences, and other documentation reflecting project(s) progress.
• Write SOPs, protocol, monographs and technical reports; seek approval from management and R&D QA.
• Satisfactorily completes all development, cGMP/GLP and safety training in conformance with Departmental requirements.
• Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.
• Performs other duties as assigned.
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
Education: PhD degree with minimum of 1-2 years of industry experience or MS degree with minimum of 5 years of scientific biopharmaceutical industry experience.
Experience: Experience developing, optimizing, and executing analytical methods (HPLC / UHPLC / CAD / HPLC-MALS / etc.) for testing of in-process, bulk, and final drug product samples for biologic drug products. Experience analyzing chromatography data to support decision making in the context of drug product formulation and process development. Experience in developing formulations / formulation processes for vaccine and biologic drug products for sterile parenteral administration in both pre-clinical and clinical studies are required. Preparation of study protocols and reporting conclusions from scientific data in the fields of chemistry, biochemistry, biophysics, or related fields. Independent development of suitable methodology, study designs, and data analysis approaches to address scientific questions. Experience with additional analytical techniques to include cIEF and FTIR preferred.
Knowledge: Expert knowledge of scientific principles and concepts of chemistry and biochemistry as related to analytical method (HPLC / UHPLC / CAD / HPLC-MALS) development for the purposes of characterizing biological drug product samples. Strong knowledge of aseptic formulation and processing technologies for formulation/fill/finish processes for biological products. Knowledge of DoE and JMP analysis, GLP or cGMP requirements, and regulations / guidelines in pharmaceutical industry (FDA, USP, EU, others) is preferred.
Skills: Ability to work to tight deadlines and adapt to changing priorities in a fast-paced environment. Self-motivated and able to independently solve complex problems. Understanding in the selection of appropriate stability indicating techniques for evaluation of formulations. Understanding and hands-on experience in characterizing stability of drug products.
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
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.