Senior Specialist (Formulation) - Inhalation Analytical Testing & CRO

Spherical Search have recently partnered up with a well-known analytical testing/CRO company in the field of inhalation of drug delivery who are working with device developers and pharmaceutical companies to develop innovative and safe products.

We are looking for a Senior Specialist (Formulation) to join the team.

ROLE OVERVIEW

To operate as a scientific and technical expert in the field of aerosol formulation. This will include exercising expertise in some or all of the below: o Biologics formulation development (peptides, proteins, nucleic acids) o Particle Engineering, particularly spray drying

• Dry powder formulation, including high, low and zero shear blending techniques, as well as filling and metering processes.
• Liquid formulation, including solutions, emulsions, and suspensions.
• Pressurised Metered Dose Inhalaers (pMDIs), including formulating, filling and characterisation.
• The development of formulations, including excipient and process choices, for nasal sprays, nebulizers, pMDIs and dry powder platforms.
• Formulation of small synthetic molecules and biomolecules, including antibodies and viral vectors
• Understand physical-chemical characterisation to a high degree to profile drug substances / APIs and candidate formulations and their viability to be developed into a drug product.

To support the Business Development functions in designing and preparing new proposals of work as the Subject Matter Expert (SME) in your field. This may include:

• Participation in initial and ongoing discussions with prospective or existing customers to outline and understand the customer requirements and build a scheme of work that will constitute the proposal/contract, and support with the scientific discussions to help close new business.
• Developing a reasonable costing model and charging structure for new activities.
• Performing technical / scientific onboarding of new customers/projects into the business to the PD teams to enable smooth transitioning into project execution.

To support the Pharmaceutical Development teams in in the company in your chosen specialism, to allow delivery of the revenue-generating portfolio of work for our customers, internally and externally, efficiently, and effectively. This may include:

• Learning, teaching, and training of team members.
• Reviewing and contributing to reports and protocols for technical and scientific accuracy with regards to data analysis or conclusions, and planning of the next stage of project execution.
• Participation and leading of customer/stakeholder/sponsor discussions and presentations to ensure the knowledge is appropriately conveyed and discussed with these parties.
• The resolution of technical challenges faced by the scientific teams during project execution.
• Making critical scientific decisions to enable continued project progress and justifying those decisions to stakeholders at decision gates or if technical roadblocks are encountered.

To support our customers, academic/regulatory agency collaborations with product development programs leveraging the full range of tools and resources. This may include:

• Participating in calls, workshops, problem solving, technical discussions and project review processes/meetings as required, to leverage your experience and technical capabilities. o Lead matrixed teams to solve critical problems, moving companies technology/capability/services forward as part of internal programs, including through collaborations with the wider group.

To conduct, support and govern novel research and development in the field of aerosol-based delivery technologies and associated disease state treatments, including the development of new inventions and intellectual property primarily in the fields of formulation of aerosol based pharmaceutical technologies.

• Scope the project fully, including business case and execution plan, leading the delivery with collaborative working with other teams.

To enhance the capabilities and reputation of the company continuously.

• Present at conferences, Key Opinion Leader (KOL) meetings, conduct webinars, build promotional materials, and publish in peer-reviewed journals.
• Act as a role model for the organisation as a scientific leader and influencer in the organisation.

Act as the technical exert in inhalation/aerosol formulation and delivery technologies for the company, supporting customers, team members, academic/industrial partners, regulatory agencies, Senior Management, R&D and Business Development in this area.

EDUCATION & QUALIFICATION

• Essential - a first degree in a scientific, pharmacy or relevant discipline of grade 2.1 or above.
• PhD in relevant discipline preferable.
• Essential - extensive experience in formulation development in the drug delivery field, particularly in peptides and/or proteins
• Strongly desired, expertise in one or more of the following areas:
• Pharmaceutical aerosol formulation development
• Spray drying
• Bioavailability enhancement formulation strategies

SKILLS & EXPERIENCE

• Extensive proven experience of working in an advanced development function within the pharmaceutical industry leading exploratory product development programs.
• Excellent time management skills
• Proven ability to successfully work independently.
• Ability to manage multiple complex priorities and work under pressure.
• Strong analytical and problem-solving skills.
• Ability to present at scientific meetings, webinars, and conferences.
• Ability to work independently and in a team environment, take initiative and handle multiple tasks simultaneously with minimal supervision and adhere to reporting deadline schedules.
• Proven team management experience required:
• To demonstrate strong leadership skills and always leading by example
• Expected to have relevant scientific/technical experience whether from rising through thee company system or another appropriate pharmaceutical environment / academic institution.
• Expertise around formulation design and development activities, preferably inhalation and associated analytical methods for small and large molecules would be advantageous.
• Demonstrated proactive and organised approach, able to exert influence over those whom they do not have direct authority.
• Politically astute with excellent interpersonal skills and ability to express information and ideas in a manner that is appropriate, concise and accurate.
• Excellent customer related experience and client facing skills.
• Ability to communicate and work with personnel of all levels, internally and externally.
• Read, analyse, and interpret complex documents.
• Ability to write highly complex analytical reports, routine business correspondence, and technical procedural instructions.
• Thorough working knowledge of the company’s services, contract development / research, pharmaceutical and biotech industries
• Proven flexibility in adjusting to a rapidly evolving workload.
• Always displays adherence to and promotion of the company values.