Sr Scientist, Formulation Development

Location
Gaithersburg, MD, US
Posted
Sep 19, 2020
Ref
676798100
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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.

JOB SUMMARY

Develop formulation for vaccines and biologics to ensure superior stability and manufacturing feasibility. Lead Lyophilization drug product development for CDMO business unit. Design/Conduct pre-formulation and formulation DOE studies. Determine leading formulations for clinical trials. Prepare CMC sections related to formulation and analytical development. 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.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Key Responsibilities include:

-Design/Conduct lyophilization formulation development studies:
• 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)
• Proficient in DSC/mDSC and Freeze Dry Microscope method for the characterization of the frozen and dry formulation.
• Provide advanced technical support for lyophilization and lyophilized products for aseptic drug products manufactured for internal or external products
• 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
- 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.

Additional Responsibilities Include:

-Manage in-house stability program
-Work closely with other groups within the DVS department to characterize physical chemistry of proteins and the up/down stream bioprocesses
-Propose and design novel delivery systems for parenteral administration

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 CDMO management
-To report progress on a regular basis to the appropriate CDMO 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 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
• Strong problem-identification and problem-solving skills are required
• PhD with >3 years of scientific pharmaceutical industry experience. BS/MS with > 5 years' experience in lyophilization.
• Expert knowledge in lyophilization cycle development for pharmaceutical product
• Strong technical writing skills: preparation of formulation protocols, technical reports, SOPs and batch records
• Expertise 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 pre-clinical and clinical studies is a plus
• 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

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.