Lead Scientist, Formulation Development

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. 
Documentation:

-    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

Communication:

-    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.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

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.