Analytical Development Scientist

Sterling Pharma Solutions Limited; Shotton; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading pharmaceutical company in Shotton is seeking an experienced Senior Analytical Development Scientist to perform analytical testing and develop robust analytical methods for biological products. The ideal candidate will have over 5 years of experience and a BSc in a relevant biological subject. The role includes working in a regulated environment, ensuring compliance, and collaborating with cross-functional teams to deliver quality results.

Benefits

Competitive salary

Pension scheme

Private healthcare

Retail discounts

Cycle to work scheme

26 days annual leave

Death in service coverage

On-site health and wellbeing support

Training opportunities

Qualifications

• More than 5 years' experience in a bio-analytical testing laboratory.
• Technical knowledge to lead the development of compliant assays.
• Demonstrable experience in bioanalytical testing using HPLC.

Responsibilities

• Lead the development of analytical methods for biomolecule characterisation.
• Perform analytical testing using HPLC, icIEF, and other techniques.
• Document laboratory results and ensure compliance with procedures.

Skills

Analytical testing of biological products

HPLC/UPLC

Good interpersonal and organisational skills

Problem-solving approach

Education

BSc in a relevant biological subject

Tools

Microsoft Office (Excel, Word, PowerPoint)

Job description

Overview

Senior Analytical Development Scientist role involves performing analytical testing of biological pharmaceutical products (such as therapeutic proteins, monoclonal antibodies, bioconjugates or antibody–drug conjugates) and developing and qualifying robust analytical methods in a regulated environment. The role includes development and validation of new analytical methods for process development, product release, stability testing and characterization of bioconjugates/ADCs, providing troubleshooting support to operations teams, ensuring compliance with standards and protocols, and delivering accurate results on time. Collaboration with other scientists and project managers is expected to achieve project objectives and deliver high‑quality solutions to clients.

Responsibilities

• Lead the development and qualification of analytical methods for biomolecule characterisation, bioconjugate/ADC testing, physicochemical analysis at the protein level including product related impurities, product developability, clinical in-use studies, and formulation development.
• Perform analytical testing using a range of techniques including pharmacopeial physicochemical methods, HPLC (SEC, HIC, PLRP, CEX), icIEF, CE-SDS, spectrophotometry (FTIR and UV‑VIS), ELISA, and other relevant techniques.
• Carry out routine and non‑routine activities required to support analytical development.
• Ensure testing is reported within the most efficient timeframe.
• Maintain laboratory conditions, perform housekeeping, conduct self-inspections, manage stock control, support re‑order systems and communicate with key suppliers.
• Trend data and assist in quality and technical investigations.
• Accurately document laboratory results in accordance with company procedures.
• Ensure training status is compliant with matrix requirements and assist in training other laboratory staff.
• Maintain and improve knowledge of bio‑analytical techniques and procedures.
• Liaise with functional groups within and outside Analytical Services to progress projects.
• Prepare and execute laboratory protocols and reports as assigned.
• Qualify reagents, reference materials, analytical techniques and relevant equipment.
• Work with due regard to health and safety of self and others and flexibly across the site to meet business needs.
• May supervise junior staff members (e.g., Analytical Development Scientists).

Qualifications

• BSc or equivalent qualification in a relevant biological subject area.
• More than 5 years' experience in a bio-analytical testing laboratory (academic or industry).
• Technical and scientific knowledge to lead the development and qualification of non‑regulated and suitably compliant assays within a regulated environment, including validation of methods to ICH.
• Demonstrable experience in bioanalytical testing of biological pharmaceutical products (ADCs, therapeutic proteins, monoclonal antibodies) using techniques such as HPLC/UPLC and capillary electrophoresis (IEF, SDS).
• Experience with Quality by Design (QbD) and Design of Experiments (DoE) and statistical modelling methods and software is advantageous.
• Excellent communication skills and the ability to deliver effective technical presentations to a wide audience.
• Good interpersonal and organisational skills; attention to detail; ability to work in a team and individually.
• Ability to critically assess data and adapt to new challenges; strong problem-solving approach.
• Good awareness of cGMP and regulatory requirements including USP, Ph. Eur., and ICH guidelines applicable to the role; competency with IT systems, particularly Microsoft Office (Outlook, PowerPoint, Word, Excel).

Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates irrespective of sex, race, disability, age, sexual orientation, marital status, pregnancy or maternity, religion or belief.

Benefits

• Competitive salary
• Pension scheme
• Private healthcare
• Retail discounts through reward gateway
• Cycle to work scheme
• 26 days annual leave plus bank holidays
• Death in service coverage
• On-site health and wellbeing support and medical consultation
• 24/7 employee assistance programme
• Training and opportunities for further career development