Formulation & Analytical Development Manager
Jason at CK Science is currently recruiting for a Formulation & Analytical Development Manager to join a truly independent UK pharmaceutical company, focused on researching and developing novel dermatological treatments on a permanent basis.
We are looking for a highly talented, senior individual with a blend of knowledge and experience including the management and overseeing of product formulation & analytical development and product manufacturing process development, comprising of the formulation, analytical development and pilot production teams. You will strengthen and drive cross-functional relationships, as a mechanism to ensure that strategy is developed and executed to the pharmaceutical development plan for each product candidate. You will interact and influence cross-functional teams including but not limited to Research, Clinical, Marketing, Quality, Regulatory, and Purchasing & Supply. You will also be heavily involved with continuous product improvements for existing commercial products with regards to manufacturing and analytical methodology and assist with changes to products whilst ensuring compliance is maintained to the relevant product licences and continuity of product supply is not affected.
Your main responsibilities in this role will be to:
- Manage and plan the workload in order to meet the required deadlines with regards to new product development (both formulation and analytical), IMP and stability trial production, assisting in technology transfer into the commercial plant and resolving production/analytical issues in a timely manner to ensure continuous supply of product
- Manage the analytical development team from initial development methods through to fully validated licensed methodology
- Ensure a high level of development interaction from an early stage between the formulation and analytical development teams
- Manage the Pharmaceutical Development teams including a level of supervision according to individual's needs, in order to train them in the relevant processes and maintain their progression and development
- Supply finished product for clinical and early-stage stability trials
- Represent the team during audits/inspections
- Take responsibility for the management of non-conformances and CAPAs within the area of responsibility
- Ensure the manufacturing facility operates in accordance with GXP ensuring that on-going requalification, microbial monitoring etc. is performed and evaluation of the results obtained as required
- Validate equipment and the facility as required.
- Ensure all analytical methodology is appropriately developed and validated during the new product development process.
- Evaluate packaging, raw material and process changes.
You are required to have the following qualifications, skills and experience:
- An excellent knowledge of the development of new products (medicinal, medical devices and/or cosmetics) is essential along with accomplished report writing skills
- Knowledge of topical dosage forms would be advantageous
- Extensive experience working in a GXP pharmaceutical environment
- Experience in pilot production and the commercial manufacturing environment would be beneficial along with an understanding of analytical methodology
- The role requires ability to 'problem solve' and work under pressure to meet demanding timelines
- Strong leadership and management skills to ensure the potential of the Pharmaceutical Development teams are realised
- A collaborative working style and the ability to establish effective working relationships across different roles and cultures, both internally and with external partners
- A good knowledge and use of computer software is required
- A degree or equivalent in a relevant scientific discipline
If you are employed by this client you will be joining a reputable British pharmaceutical company that develops well known and widely prescribed products for the treatment of a variety of skin disorders, such as psoriasis, eczema, dry skin conditions and acne.
For more information or to apply for this Formulation & Analytical Development Manager position please contact Jason on +44 (0)1438 723 500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST32370 in all correspondence.