Scientist/Staff Scientist/Sr.Scientist, Formulation Development

This individual functions independently and productively as a scientist, engineer, or group head and is actively engaged in process and product development within a dynamic project team. Due to their strong technical knowledge, initiative and scientific commitment, this individual makes significant scientific, technical and strategic contributions within Formulation Development Group as well as their project teams. They are expected to take a leadership role in terms of a specific discipline or expertise, assist in moving projects forward toward pre-clinical and clinical trials, or improvements of existing processes and products.

Knowledge/Technical Expertise

  • Has considerable knowledge/expertise relevant to dosage form development of biologics and/or pharmaceuticals
  • Knowledge/expertise should be practical and focused pertaining to lab-related activities. Examples might include:
    • Protein biochemistry (protein folding, protein degradation, aggregation, etc)
    • Biophysical (thermodynamics, spectrophotmetry, etc)
    • Analytical (HPLC, electrophoresis, assay development, etc)
    • Process engineering (filtration, cryovessels, etc.)
    • Lyophilization expertise
    • Drug delivery expertise
    • Pharmaceutics
  • Knowledge/expertise should be general/conceptual, reflected in an ability to integrate complex and diverse pieces of information when administering a project and addressing larger, strategic activities. Examples may include:
    • Awareness of performance requirements for parenteral product
    • Awareness of requirements for GMP manufacture of drug product
    • Awareness of most drug product development aspects beyond area of focused experience or expertise
  • Developing an increasing understanding of all aspects of a project including drug product specific and across all functional areas.

Project Responsibilities

  • Implement knowledge/expertise within a lab group/project team to successfully execute some aspect of a project. This should involve a complement of technical and logistical/strategic activities.Examples may include:
    • Preformulation of a specific molecule
    • Formulation/dosage form development of a specific molecule
    • Process development of a specific molecule
    • Interacting with appropriate upstream and downstream functional areas (cell culture, purification, clinical, marketing, etc) of clients to determine appropriate configuration and delivery system for a specific dosage form
    • Participation in decision-making processes within the project team by actively engaging in scientific and technical discussions.
    • Contributing to regulatory filings as appropriate
    • Representing Drug Development (Analytical, Formulation, Pre-Clinical Development, Process Development) Group on a specific project
    • Chairing a specific meeting with clients
  • Activities are to be carried out efficiently in a scientifically rigorous manner.

Planning and Decision Making

  • Able to think in terms of global long-term project goals as well as day-to-day lab goals/activities.
  • Develops long-term plans and sets priorities within constraints of project goals/timelines. Examples include:
    • Mapping out activities/timing required to develop a pre-clinical or Phase I process/dosage form including interaction with and deliverables from other functional areas to determine appropriate material requirements, assay requirements, etc.
    • Interaction with other groups in determining goals or priorities such as mode of delivery, liquid versus lyo dosage form, etc.
    • Mapping out activities and timing to support Pre-clinical and development of Phase I/II manufacturing processes including pre-validation support activities such as process robustness, scale-up, transfer to manufacturing suites.
  • Independently designs, executes, interprets and reports results on their work.
  • Expected to solve the majority of problems that arise with little supervisory input.

Scientific & Technical Leadership

  • Builds credibility within lab group by performing high quality work.
  • Expands the conceptual framework or the technical capabilities of Formulation Group:
    • Technology development
    • Use of the literature
    • Systems development
  • Teaches others regarding their expertise, mentoring and training other members of Drug Development Group as appropriate.
  • Effectively communicates results of own work though scientific meetings, presentations, discussions and documentation.
  • Expected to review/critique/question the science within Drug Development Group.

Supervision

  • No/some supervision required on day-to-day activities and only cursory overview on most accomplished tasks.
  • Supervisory input focused on status and future of project or technical area and long-term development path.
  • May have formal supervisory responsibilities, in which case the individual must:
    • Create goals and development plans for direct reports
    • Responsible for teaching, guiding, mentoring direct report(s)
    • Responsible for overseeing the activities of direct reports and ensuring tasks are accomplished in accordance with department and business priorities

Education and Experience

  • Ph.D. degree (M.S. or B.S. with extended experience will be considered) in Chemistry, Biology, Life Sciences or related field, with 3-10 years of experience in pharmaceutical or biotechnology industry or academia.
  • A good record of publications in internationally recognized journals.
  • The ability to work in team oriented environment is essential, as this person will work closely with other members of Drug Development Group and participate on multidisciplinary project teams.

 

Interested parties are encouraged to mail their CV with a cover letter to:

Paragon Bioservices, Inc.
Attn: Human Resources
801 W Baltimore St
Baltimore, MD 21201

or

lbutler@paragonbioservices.com