Lead Scientist, Formulation Development
- Emergent BioSolutions
- Gaithersburg, MD
- Start date
- Mar 24, 2023
- Science/R&D, Biotechnology
- Required Education
- Position Type
- Full time
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
The candidate will engage in early to late phase drug formulation development of vaccines, biologics and small molecule drugs. Focus will be placed on product characterization and the generation of proposals for new projects. The candidate will require a strong background in interpretation of assay results as it relates to product characterization, technology transfer, regulatory, report writing and problems solving skills. The candidate will be required to prepare CMC sections related to formulation and analytical development.
II: ESSENTIAL FUNCTIONS
Key Responsibilities include:
- Identify and develop critical characterization assays to determine the capability of the drug products at different stages of product development
- Perform data analysis using appropriate statistical methods
- Prepare technical reports, project monthly reports, PowerPoint presentations and other documentation reflecting the project(s) progress
- Determine primary degradation pathways for biological and adjuvant molecules, including proteins adsorbed to alum and other adjuvants
- Identify formulations matrices that ensure the stability of targeted biological and the adjuvant molecules in liquid and lyophilized vaccines
- Possess broad knowledge on quality and regulatory requirements such as USP, ICH, GLP/cGMP
- Conduct all work in compliance with Emergent’s Standard Operating Procedures and regulatory requirements.
- 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; 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.
III: MINIMUM EDUCATION, EXPERIENCE, SKILLS
- PhD with minimum of 5 years of scientific pharmaceutical industry
- Expert knowledge of scientific principles and concepts related to vaccine development
- Strong technical writing skills: preparation of formulation protocols, technical reports, SOPs and batch records
- Experience in developing formulations of vaccine and biologics for sterile parenteral administration in both pre-clinical and clinical studies are required
- The candidate will have the ability to work to tight deadlines and adapt to changing priorities in a fast paced environment
- Ability and understanding in the selection of appropriate stability indicating techniques for evaluation of formulations
- Understanding and hands-on experience in running stability programs
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.
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.
Stock Symbol: EBS
400 Professional Drive
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