Analytical Development Lead – BDD Pharma Ltd. 09 May 2023
We are looking for an experienced Analytical Development professional to join our team as we expand our manufacturing services. This is a technical position with responsibility for developing, validating, and transferring analytical methods between sites and providing analytical support to the R&D and production teams. This role will include QC testing activities.
Location: BioCity Scotland, Bo’Ness Rd, Newhouse ML1 5UH and Bio-Imaging Centre, Medical Block, Glasgow Royal Infirmary, Glasgow, G4 0SF
Salary: Competitive
Contract: Full time 37.5 hours a week.
Reports: Head of QC
BDD Pharma Background
BDD Pharma is a rapidly growing research focused drug delivery company based in Glasgow with clinical trial, formulation development and GMP manufacturing capabilities. We specialize in the development of novel pharmaceutical products and undertaking bespoke clinical services which help our customers better understand how their drug delivery systems perform. When you join BDD, you become part of a team dedicated to supporting the development of new medicines and improving the health of others.
About the Job
We are looking for an experienced Analytical Development professional to join our team as we expand our manufacturing services. This is a technical position with responsibility for developing, validating, and transferring analytical methods between sites and providing analytical support to the R&D and production teams. This role will include QC testing activities.
There are opportunities for an ambitious person who would like to grow and develop into a Analytical Development managerial role.
Main Responsibilities
Design and execute experimental plans to develop, transfer and validate analytical methods and QC analysis as per GxP.
Sampling, analysis and releasing of raw material, packaging material, intermediate and finished products as per GxP.
Co-ordinate with external laboratories for analysing and releasing raw materials, packing materials, and finished products.
Transfer analytical methods to other internal laboratories and client sites as required.
Perform stability sample analysis.
Planning, scheduling, and prioritizing of Analytical department workload as per the business priorities.
Owns and/or ensures analytical investigations are managed in agreement with GxP standards and appropriate CAPAs are implemented.
Preparation and approval of test methods, study protocols and study reports
Prepare and execute protocols for IQ/OQ/PQ of laboratory equipment where required
QC review of manufacturing documentation (e.g. IMPD, BMR)
Maintaining a high level of scientific expertise and keeping up to date with current technical and regulatory expectations
Experience in solving technical problems observed during method development and routine method operation.
Training colleagues in analytical processes
Support in various Quality audits (e.g., Internal, Client, MHRA etc.)
Education, Qualifications and Experience
Degree level qualification in pharmaceutical sciences or chemistry related discipline or relevant experience in laboratory role
Extensive analytical development/QC experience within the pharmaceutical industry, minimum 5 years
Experience in developing HPLC and dissolution methods
Understanding of oral dose release requirements
Experience in a GMP environment preferred
Experience with Chemstation/OpenLab HPLC software (desirable)
Personal Attributes
Have strong communication skills (written and verbal)
Have a strong continuous improvement mindset
Have the capacity to work using own initiative, and demonstrate ability to manage multiple projects and timelines
Flexibility towards work assignments and new learnings
Demonstrate an ability and willingness to help resolve complex problems as they arise
Company Overview
BDD Pharma is rapidly growing research focused drug delivery company based in Glasgow with clinical trial, formulation development and GMP manufacturing capabilities. We specialise in the development of novel pharmaceutical products and undertaking bespoke clinical services which help our customers better understand how their drug delivery systems perform. When you join BDD, you become part of a team dedicated to supporting the development of new medicines and improving the health of others.
Why join BDD?
We offer a competitive salary and benefits package which includes private healthcare through Vitality, a generous pension scheme and access to our employee assistance programme with Health Assured.
You will be part of a young workforce with an open and transparent culture which is maintained throughout the business.
You will receive 35 days annual leave including bank holidays.
We offer a unique working environment as a combined CRO and investigative site with integrated formulation development, GMP manufacturing and clinical research services. This means that every day is different. Working at the cutting edge of early-stage drug development and clinical research provides a challenging environment with continued learning.
The opportunity to work on a variety of projects across a range of therapeutic areas, helping to shape the development of new medicines with some of the world’s biggest pharmaceutical companies and those at the forefront of technological advances.
Job Type: Full-time
Benefits:
Company pension
Private medical insurance
Wellness programme
Schedule:
Monday to Friday
Work Location: In person
