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Head of Pharmaceutical Development
2 months ago
Head of Pharmaceutical DevelopmentEssential Job Function:Lead and direct the formulation and process development scientists and activities associated with client engagements. The role’s primary accountability is for achieving client success in the leadership, planning and execution of client projects. This function leads the team that manages client projects to develop and formulate products and process to meet clients’ needs and expectations for product functionality, timing of implementation and clinical batch production through the process validation stage. This includes the coordination of all site functions and the development team to address clients’ specific needs. The role also has the responsibility for directing and mentoring the pharmaceutical experts and scientists within the department and for developing a scientific strategy to support business development in attracting and engaging new clients. The role also oversees the site’s validation activities.General Information: · Minimum of 10 years of experience in the pharmaceutical formulation development, process engineering and validation is essential with a demonstrated track record of success. · Master’s Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field is required. A PhD in the same is highly desirable. · Must be capable of making decisions and accepting ownership of the outcome, demonstrating impeccable integrity and intellectual honesty. · Must possess strong leadership, management, and problem-solving skills with a proven track record of successfully leading multidisciplinary teams. · Must be a clear and concise communicator. · Must be organized and self-motivated with a strong work ethic and an obvious passion for the industry. · Must have prior “hands on” process engineering and validation experience and possess an in-depth knowledge of pharmaceutical development as it relates to solid oral dosage forms. · Must have experience with regulatory requirements and quality systems related to pharmaceutical development, including cGMP, FDA, and ICH guidelines and associated regulatory filings such as NDA, ANDA, 505(b)2, IND, etc. · Strong business acumen and strategic thinking skills, with the ability to drive innovation and business growthResponsibilities include but are not limited to: · Prioritizing work, providing direction and leadership for the formulation and process development and the validation departments to ensure ongoing alignment of GAT/PS to industry trends and company objectives. · Overseeing the planning, execution, and monitoring of client projects, ensuring adherence to timelines, scope, and quality standards. · Supporting Business Development in attaining new opportunities through scientific outreach, supporting client visits, holding training seminars and other means as needed. · Serving as the primary in-house technical resource for engaging new clients, understanding client needs and establishing and maintaining relationships to drive client satisfaction. · Leading, mentoring, and developing a team of scientists and engineers, fostering a culture of collaboration, innovation, and continuous improvement. · Overseeing the site’s validation activities. · Providing technical guidance and expertise in formulation development, process optimization, and scale-up activities, using advanced scientific principles and methodologies. · Developing internal requirements and standards to ensure alignment with industry standards and client regulatory requirements for filings (IND, NDA, ANDA, etc.) throughout the formulation and process development process, including documentation, reporting, and quality control. · Collaborating closely with other departments, including analytical development, procurement, manufacturing, business to support integrated drug development programs and seamless technology transfer. · Collaborating with other departments, such as business development and sales services to ensure that client work is scoped, forecast, and billed as required. · Driving process optimization initiatives, implement best practices, and identify opportunities for innovation and efficiency gains in engaging clients, formulation and process development activities. · Leading team to identify and mitigate risks associated with formulation and process development projects, proactively addressing challenges to ensure project success and clear communication with clients. · Collaborating effectively with other scientific teams throughout Glatt. · Remaining abreast of industry trends, emerging technologies, and competitive landscape in formulation and process development, providing insights and recommendations to support business growth and differentiation. · Other tasks as assigned by management.You have the opportunity to perform an interesting and responsible job in a successful, renowned company.
If this interesting position appeals to you, we look forward to receiving your online application.
Applications that do not reach us personally via the online portal can unfortunately not be considered.
Glatt Air Techniques Inc., Human Resources, 20 Spear Road, Ramsey, NJ 07446, USA www.glatt.com
