Scientist, Formulation Development
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.
Develop formulations for vaccines and biologics to ensure superior stability and manufacturing feasibility. Conduct pre-formulation and formulation screening studies for liquid and lyophilized vaccines. Manage early stage formulation samples from preparation, to stability storage, to distribution for testing and data analysis. Support various projects by managing timeline, key deliverables, data reporting and strategy design.
- Identify formulations matrices that ensure the stability of targeted biological and the adjuvant molecules in liquid and lyophilized vaccines
- Design and conduct formulation studies at various stages of development to provide data to support early phase clinical trial, such as stability, solubility and effects of pH
- Develop appropriate assays to characterize the content and the purity of the biological and adjuvant molecules in the liquid and dry presentation
- Determine primary degradation pathways for biological and adjuvant molecules, including proteins adsorbed to alum and other adjuvants
- Develop physiochemical and immunological methods required for formulation optimization and physicochemical characterization of a final drug product.
- Perform statistical analysis of research data
- Prepare technical reports, project monthly reports, PowerPoint presentations and other documentation reflecting the project(s) progress.
- In lyophilization work for internal (Emergent) or external (CDMO client) projects (for a candidate with Lyo experience):
- Has deep understanding of lyophilization technology, theoretical knowledge and hands-on experience to lead projects
- Can develop cycles for various types of samples (bacterial, virus, recombinant protein, peptides, other)
- Provide advanced technical support for lyophilization and lyophilized products for aseptic drug products manufactured for internal or external products (CDMO)
- Lead complex investigations and/or regulatory responses
- Lead characterization of commercial lyophilizers and/or mathematical modeling
- Provide training on lyophilization in formal and informal settings to other scientists, quality operations and operations support.
- Assist with development, assessment and implementation of process analytical technologies for lyophilization
- Lead and/or advise on technical transfer and scale-up
- May conduct small-scale lyophilization experiments and/or direct production-scale
- Manage inhouse stability program and sample inventory
- Work closely with other groups within the Process and Analytical Development Department to characterize physicochemical properties of proteins and/or biological products.
- Work closely with up/down stream bioprocesses team to characterize drug substance samples
- Propose and design novel delivery systems for parenteral administration
- Write internal reports, technical documentation and other appropriate documents as required
- Adequately and accurately document technical work in laboratory notebooks
- Work within internal and external quality systems to ensure documentation trails are maintained throughout
- Writing and reviewing of appropriate technical MBR, SOPs for use both internally and at CMO and/or CROs
- To communicate ideas and strategies with colleagues and the Process & Analytical Development management
- To report progress on a regular basis to the appropriate Process & Analytical Development management
- To monitor and communicate progress, and highlight delays or potential risks to project timelines
- Present technical data and information to the function as appropriate
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- PhD or MS with minimum little or no pharmaceutical industry experience
- Knowledge of scientific principles and concepts related to vaccine development
- Strong technical writing skills: preparation of protocols, technical reports, SOPs and batch records
- Experience in formulation development for both liquid and solid dosage forms is required.
- Experience in developing formulations of vaccine and biologics for sterile parenteral administration in both preclinical and clinical studies a plus but not required
- The candidate will have the ability to work around tight deadlines and adapt to changing priorities in a fastpaced environment
- Ability and understanding the selection process of appropriate stability indicating techniques for evaluation of formulations
- Understanding and handson experience in running stability programs a plus
Physical/ Mental Requirements
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 40 lbs, and pull 40 lbs occasionally. Use phone, fax, copier, and computer. Use hand tools. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Work around noise above conversation level, where ventilation is needed, with restricted access to laboratory.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.