Job Description
Unit Name
Technical & Scientific Solutions
Job title
Technical & Scientific Solutions Manager
Current holder
Vacant
Location
UK
Reports to
(Title of line manager)
Date of creation/revision
Head of Technical & Scientific Solutions
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India
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Overall Purpose of Job:
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Provide expert technical knowledge and expertise to the business unit internally and
externally
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Attend formal Scientific Advice and other meetings with regulatory agencies on
manufacturing and technical issues
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Supervision and management of a team responsible for technical support and
expertise within the business unit.
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Project management of assigned projects.
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Management of budgets for projects
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Cross functional liaison internally with other business units to ensure timely supply of
product to market
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Review and approval of sections of Regulatory Dossiers (Module 2 and Module 3),
technical documentation (BMRs, technical reports and summaries, etc) to support
manufacturing & regulatory activities.
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Training and development of team members through appropriate coaching and
mentoring activities
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Other tasks as delegated by Line Manager which contribute to overall running of the
business unit
PREFERRED QUALIFICATIONS
Bachelors degree in Chemistry, Pharmacy ; or other technically relevant graduate
level qualification. Post graduate qualification (e.g. MSc, PhD) degree in Chemistry,
Pharmacy or other technically relevant discipline.
ESSENTIAL EXPERIENCE
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A minimum of 7 years experience in a technical role (Production/QA/Formulation
development, regulatory CMC) within the pharmaceutical industry in regulated
markets.
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At least 7 years management experience including line management responsibilities
for a team
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Project managed a wide range of projects of differing complexity & value
using at least one formal project methodology. Have proposed and reported to
senior management on significant projects
Demonstrated ability to define & translate project strategies into objectives,
identifies & leads resources to focus on objectives and follow through to
completion
Able to manage budgets for projects and other business activities
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PREFERRED EXPERIENCE
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Excellent technical knowledge of all solid, semi-solid & liquid pharmaceutical dosage
forms including sterile products.
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Have written a number of expert reports and QOS for regulatory submission.
Can help define and progress a regulatory strategy from initiation through to
submission.
Undertaken due diligence activities for CMC documentation for in-licensed
and new products
Can actively resolve technical /manufacturing issues arising during
manufacture of products
Aware of all parts of full regulatory submission (all modules).Understands
needs & has working knowledge of eCTD and NEES submissions
Has 5 years or more experience of practical analytical chemistry covering
multiple release sites and in process testing.
Can fully understand analytical validation studies, and is able to interpret
analytical results in depth and address queries relating to the justification and
generation of specification limits etc. May have authored analytical validation
reports.
Have developed formulations in a wide range of dosage forms with 5 years
plus experience. Fully appreciates formulation and manufacturing changes on
bioequivalence can justify biowaivers etc.
Has comprehensive understanding of formulation and manufacturing changes
on clinical and pharmacokinetic parameters. Can interpolate from dissolution
results likely effects on bioavailability & bioequivalence etc. Has some
knowledge of non-clinical data and how this may impact (e.g.) related
substances testing and limits (ICH Q3B)
Thorough knowledge of API issues affecting product quality and supply. Can
advise on approaches to dual sourcing, can write DMF/ASMF & assist in
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monograph and CEP development. Fully conversant with EU directives and
ICH guidance with regard to API’s
Thorough understanding of GMP requirements for manufacturing, deviations,
planned changes. Understands recalls and complaints handling processes.
Approves internal SOP’s Can advise on approaches to PQR’s an non
conformance reports (NCR)
Good understanding of batch release arrangements. Some knowledge of
arrangements for distribution and supply. Can liaise with releasing QP’s at
equivalent level on technical (manufacturing/formulation/packaging) issues
affecting release.
Fully conversant with IT systems used in the business across a wide range of
business areas.
Full working knowledge of all Office applications, financial systems such as
SAP for budgetary control, Can design/use & validate complex spreadsheets
for data analysis (e.g. stability data, dissolution data including trend analysis,
regression statistical interpretation etc.))
OTHER KNOWLEDGE AND SKILLS REQUIRED
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Excellent grasp and use of grammatically correct written and spoken English
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Working knowledge of all MS Office applications, Adobe Acrobat, and web
applications
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Excellent logic, analytical and reasoning skills