Senior Technical Specialist

Job Title: Senior Technical Specialist

Location: London

Duration: 12 month contract

The Client: Fast growing global speciality pharmaceuticals company

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

Provision of technical support and expertise to all relevant activities within the business unit
Project management of assigned projects
Authoring, review and approval of technical documentation (BMRs, technical reports and summaries ,etc) to support manufacturing & regulatory activities
Authoring, review and approval of sections of Regulatory Dossiers (Module 2 and Module 3) in CTD format for use in all submission related activities
Management of and participation in, technical transfer activities with associated document authoring and review
On site attendance at manufacturing sites to resolve manufacturing/technical issues affecting continuity of supply of all products
Other tasks as delegated by Line Manager which contribute to overall running of the business unit

Full details available on application

The Candidate:

A minimum of 3 to 5 years experience in a technical role (Production/QA/Formulation development, regulatory CMC) within the pharmaceutical industry in regulated markets
Excellent technical knowledge of all solid, semi-solid & liquid pharmaceutical dosage forms including sterile products
Project managed a number of technical &/or scientific projects of varying complexity
Thorough working knowledge of project management methodology (e.g. Prince 2) and practical experience with project management tools e.g. MS Project)
Fully conversant with the regulatory submission requirements and has written significant documents that have been directly included in a submission without rewording. Understands needs for eCTD and NEES submission documents
Has practical ability in authoring, review and approval of CTD components for Module 3
Can write and review Quality Expert Statements and Quality Overall Summaries
Fully conversant with the requirements of ICH Q2. Has up to 2 years practical analytical experience in the areas of assay, dissolution, related substances or similar
Can design and specify a stability protocol. Can understand specifications and limits and how they are derived
Has practical experience of formulation development of up to 2 years in a limited range of dosage forms or via trouble shooting formulation issues in production
Has some knowledge of clinical efficacy studies and pharmacokinetic studies and the effects of formulation and manufacturing on efficacy and kinetics
Has understanding of simple cost structures COG's NPV etc.
Good knowledge of API issues and requirements for e.g. dual sourcing, fully conversant with EU directives and ICH guidance with regard to API's & is able to review/amend DMF/ASMF
Complete understanding of GMP requirements for manufacturing.
Can write and approve internal SOP's
Understanding of batch release arrangements and issues arising during manufacture that affect release
Fully conversant with IT systems used in the business across a wide range of business areas and is aware of submission technologies (eCTD/publishing)
Can design/use complex spreadsheets for data analysis (e.g. stability data, dissolution data)
Can use all applicable systems, databases etc. including document management systems

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.

About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email

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