Non-Clinical Development Ops Manager Job in Basingstoke RG291BY, Southern UK
Primary Role
Under the direction of the Senior Non-Clinical Development Operations Director, Specialty Pharma, the Manager, NCD Operations is responsible for compliance and training of Non-Clinical Development staff and helps, to ensure Pharmaceutical Sciences, Biosciences, Exploratory and Discovery disciplines are compliant with the RD and corporate policies and procedures. In addition, the Manager represents NCD dept. on SOP review committees, compliance and training meetings.
The position assists in the development and implementation of departmental, global RD processes, procedures for GMP/GCP/GLP/HSE compliance as well as corporate policies and maintaining operational efficiencies.
The Manager assists with coordination of department's involvement in GMP/GCP/GLP/PV MHRA and FDA inspections and internal audits but maintains oversight of dept. vendor inspections by Shire QA and regulatory authorities.
The Manager may also support the Pharmaceutical Sciences dept. with analytics and stability data management for the development of global products; and contributes to management of the regulatory submission process; to deliver the highest quality global submission-ready standard CMC components of regulatory submissions in eCTD format and to agreed timelines and maintain dept. electronic document management system, compliant with GMP.
Responsibilities
(70%)
- Assists in the development and implementations of departmental processes, procedures and policies. Supports NCD Operation team with departmental Compliance matters relating to GMP/GCP/GLP/HSE practice (SOP matrix, training records and Learning Management Systems).
- Actively contributes to internal and external dept. inspections, maintaining oversight of vendor inspections.
- Coordinates generation/review of material safety data sheet (MSDS) for development products and maintains relevant files.
- Provides compliance and training status update in the departmental meetings.
- Participates in Therapeutic Area sub-teams as necessary.
(10%)
- Contributes to management of department regulatory submission process, ensuring compliance with the relevant guidelines.
- Keeps up to date with eCTD regulatory requirements.
- Assists in the preparation of the analytical components of the CMC sections of drug substance and drug product for regulatory submissions (e.g. CTA, IND, NDA, and MAA).
- Assists with development and coordination of the Shire electronic document management system.
- Reviews analytical test methods, validation protocols, and validation reports and CTD Module 3 components.
Reviews protocols/manufacturing requests and batch documents for manufacturing drug substance and drug product.
(5%)
- Represents NCD Operations on the global project submission teams. Carries out and/or coordinates CMC submission activities for the Product Development team. Consults the team where their input is required.
- Becomes NCD dept. key person for management of the Shire electronic document system by attending all internal training courses and be responsible for implementation of the system within the department. Be key contact with IT and the Electronic Document Management helpdesk.
- Maintains professional expertise through familiarity with regulations, scientific literature and participation in training courses.
- Assists in the development and implementations of departmental processes, procedures and policies.
- Contributes and maintain global Module 3 templates (and regional specific templates).
(5%)
- Assists with maintaining product specification files in compliance with the EU regulatory requirement
- Manages (set up, track and file) financial documents (purchase orders and invoices) scanning, emailing, retrieving, filing and archiving of GMP documents and other technical administrative support to Chemistry, Manufacturing and Controls (CMC) group.
(5%) Supports department analytical and stability project activities, including:
- Reviewing stability protocols, monitoring of analytical work at Shire contractors and maintenance of stability tracking database and project stability files.
- Evaluation of stability data and preparation of stability summary tables. Provides stability data for annual stability reports and other regulatory submissions.
- Interacting with contract laboratories on stability issues.
- Storing electronic and hard copies of stability data and reports.
- Ensuring all cGMP stability data generated for development projects are managed and evaluated in compliance with the relevant SOPs.
(5%)
- Outsources analytical and stability work to contractors.
- Reviews technical agreements for Shire contractors.
- Provides technical guidance regarding analytical issues to Shire contractors.
- Provides technical input for selecting external Shire contractors as well as managing the day-to-day contractor activities w.r.t. analytics.
Education Experience Requirements
- Bachelor's degree from a college or university in Chemistry, Chemical Engineering, Pharmacy or closely related field and 5+ years experience in the Pharmaceutical Industry or a M.S. in Chemistry, Chemical Engineering, Pharmacy or closely related field and 3+ years of pharmaceutical industry experience.
- Experience of compliance/training/inspection/audit and familiarity with MHRA/FDA inspection requirements is essential.
- Understanding of objectives and processes across multi-disciplinary functions involved in drug development, registration and quality (GxPs) is beneficial.
- Experience in writing/reviewing test methods, validation reports and stability protocols and familiarity with ICH stability and quality guidelines is beneficial.
- Familiarity with regulatory guidelines and experience in regulatory submissions (CMC Module 3 information and QOS documents) for investigational medicinal products and also product development is beneficial, although training will be provided.
- Experience in working with outsourcing model is preferred.
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