Lead Formulation Scientist

3 weeks ago

Cwmbran, Torfaen County Borough, United Kingdom Spherical Search Full time

Spherical Search is collaborating with a prominent analytical testing and contract research organization (CRO) specializing in inhalation drug delivery. This organization partners with device developers and pharmaceutical firms to create innovative and safe products.

We are seeking a Senior Specialist (Formulation) to enhance our team.

ROLE OVERVIEW

The successful candidate will serve as a scientific and technical authority in aerosol formulation. Responsibilities will encompass expertise in various areas, including:

  • Development of biologics formulations (including peptides, proteins, and nucleic acids).
  • Particle engineering, with a focus on spray drying techniques.
  • Formulation of dry powders utilizing diverse blending techniques, alongside filling and metering processes.
  • Creation of liquid formulations, such as solutions, emulsions, and suspensions.
  • Expertise in Pressurized Metered Dose Inhalers (pMDIs), including formulation, filling, and characterization.
  • Development of formulations for nasal sprays, nebulizers, pMDIs, and dry powder platforms, considering excipient and process choices.
  • Formulation of small synthetic molecules and biomolecules, including antibodies and viral vectors.
  • High-level understanding of physical-chemical characterization to evaluate drug substances/APIs and candidate formulations for viability in drug product development.

Additionally, the role involves supporting Business Development by:

  • Engaging in discussions with potential and existing clients to clarify requirements and outline project proposals.
  • Creating a cost model and pricing structure for new initiatives.
  • Facilitating the technical onboarding of new clients/projects to ensure seamless project execution.

Support for the Pharmaceutical Development teams is also essential, focusing on:

  • Training and mentoring team members.
  • Reviewing and ensuring technical accuracy in reports and protocols.
  • Leading discussions and presentations with clients and stakeholders.
  • Resolving technical challenges encountered during project execution.
  • Making critical scientific decisions to maintain project momentum and justifying these decisions to stakeholders.

In addition, the role includes collaboration with customers and academic/regulatory agencies on product development programs, which may involve:

  • Participating in calls, workshops, and technical discussions to leverage expertise.
  • Leading cross-functional teams to address critical challenges and advance the organization’s capabilities.

The candidate will also conduct and oversee innovative research and development in aerosol-based delivery technologies, including:

  • Comprehensively scoping projects, including business cases and execution plans, while collaborating with other teams.

Continuous enhancement of the company’s capabilities and reputation is vital, involving:

  • Presenting at conferences, leading Key Opinion Leader (KOL) meetings, conducting webinars, and publishing in peer-reviewed journals.
  • Serving as a scientific leader and influencer within the organization.

Finally, the candidate will act as the technical expert in inhalation/aerosol formulation and delivery technologies, providing support to:

  • Clients, team members, academic and industrial partners, regulatory agencies, senior management, R&D, and business development.

EDUCATION & QUALIFICATION

  • Essential: A first degree in a scientific, pharmacy, or relevant discipline with a minimum grade of 2.1.
  • PhD in a relevant discipline is preferable.
  • Essential: Extensive experience in formulation development within the drug delivery sector, particularly with peptides and/or proteins.
  • Strongly desired: Expertise in one or more of the following areas:
  • Pharmaceutical aerosol formulation development.
  • Spray drying techniques.
  • Strategies for enhancing bioavailability in formulations.

SKILLS & EXPERIENCE

  • Proven experience in advanced development functions within the pharmaceutical industry, leading exploratory product development initiatives.
  • Exceptional time management skills.
  • Demonstrated ability to work independently and manage multiple complex priorities under pressure.
  • Strong analytical and problem-solving capabilities.
  • Ability to present at scientific meetings, webinars, and conferences.
  • Experience in team management and demonstrated leadership skills.
  • Expertise in formulation design and development activities, particularly in inhalation and associated analytical methods for small and large molecules.
  • Excellent interpersonal skills and the ability to communicate effectively with personnel at all levels.
  • Ability to read, analyze, and interpret complex documents and write detailed analytical reports.
  • Thorough knowledge of the company's services and the pharmaceutical and biotech industries.
  • Flexibility in adapting to a rapidly evolving workload.
  • Commitment to promoting the company’s values.

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