Job Description

NextPharma is a leading European pharmaceutical CDMO focused on attractive technology niches.

Since its foundation in 1989, the Livingston site has evolved into a global player in the development and application of both traditional and novel drug encapsulation technologies that are supported by modern and commercial scale manufacturing facilities.

Our Vision:

Our vision is to be the leading and most trusted, reliable and innovative Europe-based CDMO by upholding the highest industry standards and exceeding customer expectations, while driving strong, sustainable growth for the company.

Job Purpose Development analyst:

To conduct analysis, technical stability studies, development, validation and transfer of analytical methods. The role will be responsible for providing technical expertise at both a theoretical and practical level. The ideal candidate will therefore have a pharmaceutical analysis background and have gained experience within a cGMP, FDA and MHRA regulated environment.

Key responsibilities and accountabilities:

Work as part of a team alongside other analytical departments. Actively involved in performing analytical activities to determine fitness for purpose of inished products
Conduct analysis to support formulation development

Perform method development, validation and transfer analysis of analytical methods for Liquid Fill hard capsules.

Technically competent in analytical activities (e.g., method development and validation, HPLC, GC, Karl Fisher and Dissolution) Validation activities performed under current cGMP and ICH Q2 Writing of development and validation, protocols and reports Checking of analytical data
Supporting good internal and external relationships and communication

Comply with company health and safety procedures

Person Profile: Development Analyst

Personality:

Results oriented with a positive outlook and clear focus on high quality output: Solid planning and organizational ability; Reliable, tolerant and dependable: Enjoy working in a stimulating environment. Comfortable dealing with peers and customers. Goal-oriented: Able to work under pressure and meet deadlines; Excellent communication/ presentation skills. Able to get on with others and be a team player, but is equally comfortable working independently.

Personal Situation

Flexible and able to work extended hours when required.

Specific Job Skills:

Required:

Relevant qualification, HNC/HND/Science Degree or Equivalent

An understanding of drug development and manufacturing processes

Demonstrated technical competence of the technical and practical skills involved in analytical activities to prescribed quality standards

Must be skilled in analytical techniques e.g., HPLC, Dissolution, Gas Chromatography, and Karl Fisher techniques

Experience of the technical and practical skills involved stability studies, method development, transfer and validation

Able to communicate well with others, both laboratory and non-laboratory based

Able to work with minimal supervision.

Good understanding of working within cGMP/GLP environment.

Desired:

Experience of working within a fast paced pharmaceutical or biotechnology industry

Minimum 3 years previous relevant experience in similar environment

Ability to work to key regulatory and compliance requirements

Experience of Chromeleon software

Experience of chemical analysis within a pharmaceutical environment (with formulations of drug products for pre-clinical and clinical trials).

Experience of data reporting and data checking to GMP standards

Able to work with minimal supervision and provide guidance to junior analytical analysts

Understand and demonstrate a pragmatic approach to problem solving with GMP constraints.

Able to communicate well via written media with specific empehsis on report writing.

Computer skills:

Must be competent in the use of MS Office, particularly Excel and Word,
e-mail and internet.

Literacy and Numeracy:

Must be competent in writing reports both for internal use and for customers. Must be competent in the interpretation of analytical data.

Business Presentation Skills

: Must be an excellent face-to-face and telephone communicator.

Please note - we are unable to offer Visa Sponsorship for this role.

Job Types: Full-time, Permanent

Benefits:

Company pension Cycle to work scheme Free parking Health & wellbeing programme Life insurance On-site parking Referral programme
Ability to commute/relocate:

Livingston EH53 0TH: reliably commute or plan to relocate before starting work (required)
Experience:

Analytical Development: 3 years (required)
Work authorisation:

United Kingdom (required)
Work Location: In person