This role is responsible for leading and managing the R&D team at the Sellersville site. The R&D Head will ensure that the highest standards of patient centricity and compliance are applied and embedded within the team, that exceptional customer service is received in the delivery of all projects and that a focus on commercial success is applied to all work. In addition, they will be responsible for timely development of AGILE product portfolio.

Essential qualifications & experience

• Masters or PhD in Pharmaceutical Sciences or a related field.
• A minimum of fifteen years of demonstrable experience of leading teams in a regulated environment, as well as a strong relevant technical background and ability to manage complete development cycle activities.

Key Roles/Responsibilities:

• To provide leadership to the R&D teams (Formulation and Analytical), giving support and direction to enable the team to provide the highest standards of service to our customers.
• Ensure all operational activities within the team are run effectively and efficiently to support the achievement of budget through on time and in full delivery of high quality product to customers.
• Support the development and delivery of a strategic plan for Sellersville site to drive the function forward in meeting business needs and communication of operational objectives, challenges and achievements
• Ensure all operations support activities align with organizational requirements with regards to Quality, EHS, FDA, cGMP and legislative expectations and requirements.
• Build and deliver a culture of operational excellence with a strong focus on the identification, scoping and delivery of operational and efficiency improvements, both within the R&D function and cross functionally to introduce process improvements.
• Lead the technical support for the Pharmaceutical Development and Analytical Technology teams providing technical assessment, guidance and advice to the team on process issues.
• Act as the primary technical interface for the technical teams with customers, supporting the assessment of RFP’s, developing proposals and supporting the ongoing manufacture of products.
• Work with the Project Management and Production Support Teams to ensure the delivery of projects on time and effective support of ongoing operations.
• Liaise closely with the Quality Function and drive departmental capabilities around the management of deviation investigations, CAPAs, self-inspections and change control processes.
• Coordinate the review and monitoring of ongoing performance of the manufacturing processes, proposing optimization and improvements as necessary.
• Work with the site ESH team and engineers to ensure process safety requirements for the manufacturing operation are adequately addressed.
• Maintain close links with senior management in customer groups, and relevant external research organizations. Will develop and maintain best research practice in industry through these contacts.
• Manage the manufacture and supply of reference standards from the group.
• Ensure the necessary GMP requirements for processes are identified and established (i.e. Critical quality attributes and critical quality control parameters). Support updates to registration document technical details as required.
• Establish the technical direction and co-ordination of the area(s) in consultation with senior technical management.
• Ensuring that all People Management actions are competed in a timely manner within the team, specifically in relation to the annual performance management process. Lead, Manage, develop and motivate staff, ensuring the development of skill enhanced multi-functional teams, developing individuals and implementing effective training programs. Manage all recruitment, employee development, coaching and mentoring activities with your team to ensure goal delivery
• Prepare, manage and control the departmental operating budget and capital expenditure to ensure the effective provision of services, whilst seeking cost reduction opportunities
• Provision of knowledge and advice on technical aspects of drug product development, execution and optimization.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Relocation assistance
• Vision insurance

Experience level:

• 11+ years

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Sellersville, PA 18960: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Work Location: In person

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