Analytical Development Lead

Job Description - (Senior) Principal Scientist, Analytical Science

Job Title: (Senior) Principal Scientist - Analytical Science

Department: Pharmaceutical Development

Line Manager: Team Director

Location: South Manchester (occasional travel will be required to attend client meetings, CRO visits and business development events across the UK and potentially abroad. Occasional overnight stays will be required).

Job purpose:

The primary purpose of this role is to ensure excellence in Client's analytical science provision. You have responsibility for driving the analytical science and associated regulatory components of client projects and providing mentoring and coaching to more junior analytical staff.

You keep up to date with the latest technical advances in analytical science and, where appropriate, introduce those technologies into the business.

As a senior member of the CLIENT team, you support growth of the business by providing technical consultancy and advice to Client's clients, scientific guidance to internal staff and support to business development activities.

Typical responsibilities/accountabilities:

The key responsibilities of the role are to:

• Bring analytical expertise to guide the development of fit for purpose analytical methods for a range of simple and complex drug products, and trouble shoot any method development issues.
  
  
• Understand and articulate global regulatory requirements for a CMC submission and design the product strategy accordingly.
  
  
• Bring the right / specific scientific thinking together with pragmatic design thinking to deliver product and technology solutions for client's compounds and products
  
  
• Ensure Client has the right analytical expertise and capability to support existing and new client programmes, including the introduction of new analytical technologies as appropriate
  
  
• Provide hands on laboratory trouble shooting for complex analytical challenges when required.
  
  
• Act as pharmaceutical development project leader / manager for some client projects
  
  
• Manage and review CRO activities on behalf of clients
  
  
• Management of the financial and contractual aspects of projects with clients, such as costing proposals and invoicing.
  
  
• Act as a key point of contact for Client's global client base.
  
  
• Author SOPs and / or best practices documents. Keep continuously improving Client's analytical capability, including keeping abreast of state-of-the-art analytical techniques.
  
  
• Participate and present at network events, conferences
  
  
• Provide direction, oversight and coaching of other members of staff
  
  
• Other activities that are consistent with your role and status in the Company
  
  Education, Qualifications, Experience, Skills and Capabilities:
  
  
• Educated to PhD and greater than 5 years' experience in the pharmaceutical sciences and drug development or bachelor's degree and greater than 10 years' experience in the pharmaceutical sciences and drug development
  
  
• Experience of progressing the analytical components of various drug projects through different development phases (discovery to launch) across global markets
  
  
• Wide ranging experience of interactions with global regulatory authorities
  
  
• Good understanding of ICH quality guidelines and global CMC regulatory requirements
  
  
• Ability to work collaboratively and well in a team
  
  
• Ability to meet deadlines and targets
  
  
• Ability to communicate well at all levels and to present to an audience
  
  
• Ability to influence well
  
  
• Project leadership skills and experience
  
  
• Self-motivated and able to operate independently
  
  
• Focused on own self development and willing to learn
  
  
• Ability to coach and mentor others
  
  
• Valid UK driving license
  
  Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy