Associate Scientist II, 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 and analytical test methods (HPLC / UHPLC / CAD / cIEF) for in-process, bulk drug product, and final drug product samples to establish product and process knowledge.

Perform stability and characterization studies to determine leading formulations for clinical trials and support technology transfer of formulation processes to GMP manufacturing site.

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

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.• Utilizes broad knowledge and application of the scientific theories and principles to resolve issues related to formulation and process tasks.• Develop HPLC / UHPLC / cIEF or other suitable analytical assays to measure the content, purity, and other characteristics of the active pharmaceutical ingredient, excipients, and adjuvants in the liquid, frozen, and lyophilized dry products.• Develop physicochemical characterization assays and apply them at different stages of product development.• Identify formulation matrices that ensure the stability of targeted biological and adjuvant molecules in liquid, frozen, and lyophilized drug products.• Plan, perform and execute pre-formulation/formulation study, short and long-term stability and compatibility studies and experiments to support client product/process development projects, animal toxicity studies, CTM phase I/II/III studies and more.• Establish, troubleshoot, and execute traditional and advanced formulation processes, including formulation/filtration/fill, nanoparticle formation, lyophilization• 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, 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: MS with minimum of 1-2 years of industry experience or BA/BS degree with minimum of 5 years of scientific biopharmaceutical industry experience.

Experience: Laboratory experience in developing, optimizing, and executing analytical methods (HPLC / UHPLC / CAD / HPLC-MALS / cIEF / etc.) for testing of in-process, bulk, and final drug product samples for biologic drug products. Experience analyzing chromatographic data to determine product characteristics and support decision making related to drug product formulation and process development. 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.

Knowledge: Expert knowledge of scientific principles and concepts of chemistry and biochemistry as related to analytical method (HPLC / UHPLC / CAD / HPLC-MALS / cIEF) development for the purposes of characterizing biological drug product samples. Understanding of appropriate stability indicating 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 of DoE and JMP analysis, GLP or cGMP requirements, and regulations / guidelines in pharmaceutical industry (FDA, USP, EU, others) 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

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.