Adopt a management role in pharmaceutical and technical development for GW Pharmaceuticals. Effectively manage the people in their group, lead complex projects that require cross functional working with other departments to achieve programme goals.
Key Responsibilities / ACCOUNTABILITIES
Ensure development activities within Technical R&D are on track in accordance with project timelines.
Contribute, authors and reviews CMC Regulatory documentation for GW products.
Foster and maintain a high degree of innovation and forward-thinking within the development phases of GW products.
Provides operational direction, motivation and guidance to teams leading complex assignments.
Ensure that the overall health, safety, security and environmental protection levels are kept to a high standard in the technical departments.
The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the role.
Detailed Responsibilities / ACCOUNTABILITIES
Oversees and coordinates high level planning for team research and development activities for GW projects.
Selection and development of suitable staff and facilities for pharmaceutical and analytical process development.
Manages and leads technical interactions with external contract research organisations to partner with GW on R&D activities.
Instigates development of new procedures and documentation to facilitate effective communication of pharmaceutical and analytical development to cross-functional teams.
Collaborates proactively with the CMC Regulatory Team to generate required documentation for regulatory submission of GW projects.
Acts as subject matter expert in regulatory audit preparations and responses during review.
Implements and maintains appropriate quality standards across the Technical group.
Maintaining current awareness in the areas of Pharmaceutical and Analytical sciences, Quality and Regulatory Affairs.
Promotes a culture of excellence in health, safety, security and environmental areas, making sure that risks are assessed and managed within the Technical department.
Key attributes / Skills / education ESSENTIAL
Degree level or above in a chemical or pharmaceutical subject.
Relevant experience in the management of people in scientific teams conducting pharmaceutical / analytical / chemical research and development.
Substantial experience of successfully leading teams delivering drug development projects.
Knowledge of regulatory standards within the Pharmaceutical Industry and experience of applying those into drug development projects.
Strong cGxP awareness and experience applying this within an R&D environment.
Thinks strategically supporting vision of the department.
A scientific approach to data with a high level of numeracy and statistics with excellent attention to detail.
Well-developed technical writing and presenting skills.
Experience contributing to regulatory submissions.
Experience in drug development, including drug substance and drug product areas, with a sound knowledge of Quality by Design approach in pharmaceutical development.
Strong IT skills and ability to use all key packages (Word, Powerpoint, Excel, Project) to produce, present and analyse data.
and produce compelling materials for internal and external use.
Good communications skills with an ability to adapt style and content to address the particular needs of the situation or audience.
Can lead both internal and external meetings effectively (including meetings involving colleagues and external partners).
Strong team working skills acts as an inspirational team leader and is a supportive colleague.
Attributes and Behaviours :
Displays the attributes encompassed in the GW Values.
Influences others to display high levels of integrity.
Acts as a role model for the team.
Builds positive relationships within and outside the department
Leads the efforts for change within the team. Is adaptable to changing deadlines and priorities from the business.
Influences other managers within the department to achieve high standards of quality and excellence
Ability to change the thinking of, or gain acceptance from, others to influence staff to achieve targets
Fosters a culture of learning and development, accountability and empowerment in their team.
Proactive attitude to safety and quality
Key attributes / Skills / education DESIRABLE
Ideally the job holder :
Will have played a key role in the development of medicines through clinical trials.
Will have experience in managing a large group (circa 15 people)
Will have experience with synthetic and / or botanical products
Will have experience with statistical procedures and software, particularly DoE and multivariate analysis
Have experience / understanding of pharmaceutical manufacturing scale operations