Scientist (2021) Drug Product Development

Seuss+

The Scientist is responsible for the complete trajectory of formulation development.

  • Biotechnology
  • Scientist Drug Product Development
  • Formulation
Scientist Drug Product Development
 
Our client is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so, each function is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
 
Purpose of the job
Our client’s gene therapeutic vectors are complex biological products that are subject to extensive quality testing before they are release for purpose. The Scientist Drug Product Development (DPD) is responsible for development activities pertaining to gene therapy drug products throughout their lifecycle. Overall, the Scientist DPD will play an important role in implementing the company’s formulation platform and increase understanding of the physicochemical attributes of new gene therapy products, from the preclinical development phase up to market authorization.
 
Place in the Organization
Within Global Pharmaceutical Development, the DPD group is responsible for the development of suitable formulations for the company’s gene therapy products taking into consideration expected shelf life, administration route, compatibility with primary packaging and devices. DPD operates closely with all departments within CMC as well as Research, Non-Clinical and Clinical Development providing early support to projects entering the development pipeline, up to lifecycle management of commercial products.
 
Key result areas (major duties, accountabilities, and responsibilities) 
 The Scientist is responsible for the complete trajectory of formulation development, including writing plans, managing the experimental work, analyzing the data, and reporting the results in written and oral form. The individual creates Intellectual Property with an enterprise-wide mindset and participates in project teams and other forums where formulation expertise is required.
  • Provides translation of scientific goals into actions to accomplish the targets or project needs.
  • Designs experiments to reach these project targets. She/he is accountable for accompanying documentation such as Study Plans and Study Reports. Designs (DoE), plans, supervises, and reports pre-formulation, excipient screening, formulation optimization, development stability, characterization, and compatibility studies (including hands-on time). She/he is responsible for wrapping up analyzed data in JMP files and plotting data in JMP graphs.
  • Adheres to timelines when performing experiments and aligns with technicians. Timely and adequate writing of study protocols, presenting data and reporting of study results.
  • Participates in CMC sub-teams, ensuring alignment with project needs through the CMC Lead.
  • Is accountable for proper recording of information and collection of the data and for the review of the experimental results.
  • Discusses problems and presents plans and data in the R&D meeting and DPD technical meeting. Participates pro-actively and fully engaged in DPD technical meetings. Presents at conferences and courses (external)
  • Ensures the availability of materials and equipment to perform experiments and justifies the purchase of new materials and equipment.
  • Explores and establishes novel analytical methodologies and equipment to characterize the product from a physicochemical viewpoint.
  • Provides training and coaching of interns, junior technicians, technicians, and senior technicians.
  • Lines responsibility for technicians at all seniority levels. Provides training and coaching of an interns, junior technician, technician, and senior technician. Ensures safe and pleasant work environment with sufficient personal development. Empowers people to act with speed, agility, and accountability. Responsible for setting targets for technicians technical and personal development, performing mid-year and end-year
  • Challenges the status-quo; leads and adapts to change.
  • Supports project related cross-departmental collaborations. Supports Non-Clinical and Clinical Development on compatibility topics (e.g., DP compatibility studies with administration set-up)
  • Values creation. Is responsible for innovation, conception of new ideas. Creates Intellectual Property. Is insight-driven to uncover unmet needs. Is able to write scientific publications and patents.
  • Contributes to regulatory submissions (IMPD, IND, BLA, MAA, Briefing book, dossier variations)
  • Complies to regular time writing of working hours, EHS and GRP-standards
Qualification
  • PhD in a relevant discipline, like (medical) biology, pharmaceutical sciences or (bio)chemistry
  • Proven scientific or technological background (publications, specific industry experience)
  • Possesses people management skill to manage a small team.
  • Affinity with hands-on work (i.e., willingness to work in the laboratory)
  • Familiarity with formulation development, container-closure systems and stability studies is a prerequisite, as is a working knowledge of assays and quality systems, like GMP.
  • Knowledge of regulatory policies and guidelines regarding stability (ICH, compendia (Ph. Eur., USP))
  • 3 years of relevant working experience in a comparable position, preferably in an industrial organization
 Core competencies
  • Independent, problem-solving attitude, accurate, reliable, proactive, flexible
  • Detail oriented with strong analytical skills and strong affinity with (and keen interest in) raw analytical data analyses are a prerequisite.
  • Planning and organizing able to plan multiple ongoing studies simultaneously.
  • Taking initiative: signals problems, recognizes important information, traces possible causes of problems, thinks about, and implements new working methods or new applications, brings forward original solutions for problems related to the department and function.
  • Cooperative: ability and drive to work in interdisciplinary (project) teams; strong communication skills
  • Excellent organizational and communication skills, creativity and a strong scientific mindset are key for this position.