R&D Officer/ Senior Officer (ADL)

1. To develop and validate robust analytical test methods to support formulation
development, regulatory, stability testing and quality control testing of new
pharmaceutical formulations, ensuring delivery in accordance with project timescales and
deadlines. It includes Method Validation, Assay AMV, RS AMV and Dissolution AMV.
2. To perform analytical investigations and analytical problem solving, in support of
formulation development activities.
3. To supervise the day to day analytical development activities and the analytical
development team.
4. Responsibilities include:
a. Developing and validating analytical test methods for the testing of
pharmaceutical products for manufactured specials to Good Manufacturing
Practice (GMP) and ICH Q2 requirements.
b. Developing and validating test methods for use during cleaning validation.
c. Preparing analytical method development, validation and analytical investigation
reports.
d. Solving complex analytical chemistry problems.
e. Transferring new analytical techniques to the Quality Control (QC) laboratory.
f. Purchasing, validating and maintaining equipment for analytical development
activities.
g. Controlling laboratory chemicals required for analytical development activities.
h. Planning and organizing stability testing.
i. Stability testing for products for new formulations.
j. Writing/reviewing specifications and methods of analysis.
k. Writing/reviewing of Standard Operating Procedures (SOPs).
l. Analytical support and analytical problem solving to facilitate product
development activities, including accelerated and long term stability testing and
process development.
m. Contributing to and preparing CMC Analytical development sections for
MAA/ANDAs
n. Participating in self inspections and regulatory inspections.
o. Using laboratory chemicals in accordance with Health and Safety regulations.
p. Supervising, motivating, coaching and mentoring the analytical development
team.
q. Ensuring good relations and communications with all members of the team and
responding politely and in a timely fashion to internal and external customers.
r. Working with all members of staff to maintain and develop the positive
progressive culture.
s. Observing and complying with GMP, GLP, GDP and etc
t. Observing and complying with company Standard Operating Procedures (SOPs)
Undertaking any other duties, either for this department or any other department
within the business, which may be requested by the Line Manager, for which
training and/or an explanation has been provided and understood.