Scientist, Drug Product Development

I.    JOB SUMMARY 
Conduct pre-formulation and formulation development studies for liquid, frozen and lyophilized drug products to ensure superior stability and manufacturing feasibility. Develop characterization methods for in-process, bulk drug product, and final drug product samples to establish product and process knowledge. 

Perform stability and characterization studies for R&D and clinical drug product samples. Support identification of leading formulations for clinical trials and support technology transfer of formulation processes to GMP manufacturing sites.

Prepare CMC sections related to formulation and analytical development.  Provide scientific guidance, input and ideas to solve complex problems. 

Support interface with external clients / sponsors as well as internal Emergent functions such as analytical development, quality, upstream and downstream drug substance operations, and CMO manufacturing sites.  Ensures work is completed within schedule and in compliance with Regulatory/Quality standards.

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

•    Provide leadership within internal development and external client projects on technical and operational areas.
•    Identify formulations and formulation processes that ensure the stability of biologic drug products.
•    Plan, perform and execute short and long-term stability and compatibility studies and experiments to support internal development projects, external client projects, animal toxicity studies, CTM phase I/II/III studies and more.
•    Support development of appropriate physicochemical characterization assays for in-process, bulk drug product, and final drug product samples 
•    Determine primary degradation pathways for components of biologic drug products, including protein, oligonucleotide, lipid, adjuvant, and others.
•    Support Technology Transfer to manufacturing sites by 1) completing process characterization for determination of critical process steps and parameters 2) defining operating ranges 3) completing technical transfer reports 4) supporting process start-up at commercial scale and 5) reviewing manufacturing batch record. 
•    Review, analyze, and interpret data from experiments.
•    Prepare technical reports, project monthly reports, PowerPoint presentations and other documentation reflecting project(s) progress, highlight delays or potential risks to project timelines.
•    Present project updates to immediate supervisor, team members, external clients / sponsors, and upper management on regular basis.
•    Utilize broad knowledge and application of the scientific theories and principles to solve problems related to formulation and formulation process development.
•    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. 

III. 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: Laboratory experience relevant to development of drug product formulation and formulation processes. 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 relevant physicochemical and analytical characterization techniques (e.g. FTIR / SEM / ICP / CD / DSC / HPLC / UHPLC / cIEF / etc.) preferred.

Knowledge: Expert knowledge of scientific principles and concepts related to biologic drug product and vaccine development. Knowledge of chemistry, biochemistry, DoE and JMP analysis, regulations and guidelines in pharmaceutical industry (FDA, USP, EU, others).  Understanding of appropriate techniques for evaluation of drug products. In-depth hands-on knowledge of the formulation/fill/finish processes for biologic products, aseptic formulation and processing technologies, and application of lyophilization technology.
Knowledge in GLP or cGMP is preferred. 

Skills: Excellent communication, writing, and collaboration skills. Ability to work to tight deadlines and adapt to changing priorities in a fast-paced team environment. Self-motivated, organized, and able to independently solve complex technical problems.

IV.     PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS