Process Development Lead

Location Hitchin
Discipline: Pharmaceutical
Job type: Permanent
Salary: £Negotiable
Contact name: Liam Smith

Contact email: admin@superadmin.sciencesr
Job ref: BBBH3061_1640273462
Published: about 1 month ago
Startdate: ASAP

This role is an integral part of the vision and ambition of the company. The successful candidate will help ensure that new products are appropriately developed and validated within a cGMP environment and successfully introduced to commercial production continuing the strong growth of our pharma business.

Commercial & Financial Impact
Help open up new markets and customers
Develop and nurture customer relationships with selected key accounts
Help generate new business from existing customer accounts
Responsibilities & Accountabilities

- Develop control strategies appropriate for Active Pharmaceutical Ingredients (API's) via Quality by Design (QbD) principles.
- Work closely with Production, Research and Quality functions to ensure processes are developed and implemented in time to meet project/customer deadlines.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Demonstrate excellent communication skills (verbal and written).
- Ability to develop and give presentations on technical topics.
- Ability to train/mentor associates.
- Ability to use trends and data to review and improve performance.

Skills and Education
- Degree in Chemistry or equivalent.
- Strong knowledge of the principles of QbD and control strategies.
- Experience of process development and validation as per ICH requirements.
- Technology transfer of newly developed processes to production team both internally and externally.
- Setting specification for critical parameters, raw materials, in-process checks and finished product
- Knowledge of general process development used for herbal API's will be advantageous.
- Previous use of HPLC, GC, IR, UV and TLC desirable.
- Previous experience of risk assessment and failure mode effect analysis (FMEA) desirable.
Key Performance Indicators (Indicate how performance for this role will be measured)
- Adherence to agreed project timelines.
- Successful development and validation of products.


Role fit
As part of the business strategy for expanding the product portfolio at RNL to supply an increased proportion of sales into regulated markets there is a need to increase the team size in the R&D department. The main aim is to have a more comprehensive commercial portfolio of products to help drive sales.
As part of this strategy a new laboratory is under construction due to be opened which will support an increase in the number of products being commercialised by progressing through process validation and ASMF submission.
The role may also support process optimisation and troubleshooting of existing commercial products if required.