Pharmaceutical R&D Technical Manager

Pharmaceutical R&D Technical Manager

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In this role as the R&D Technical Manager you will be accountable for directing all product development team activities. You will be responsible for coordinating the direction of the development program (Chemistry, Analytics, Engineering and Solid State Chemistry) through development and production. Direct and develop the technical control strategy with the team and ensure appropriate communication and partnership with the key stakeholders external to the team.

You will play a key role in external communication with the customer in support of the Project Manager and be responsible for the collaborative development and performance of the team members. Ensure a high level of execution during development and manufacturing phases of the program, in alignment with the deliverables in the contract, and a high level of intrinsic value addition to the product.

• Leads execution and supervision of the required process development and design to ensure a right-first-time control strategy is effectively created and implemented in production.
• Ensures that the project documentation and deliverables are kept up-to-date with the relevant data pertaining to research and production.
• Is responsible for the scientific substance of projects, ensuring accountability of team members to functional standard work deliverables as well as their integration with other development functions.
• Embraces and develops a culture of innovation for the purpose of adding value to the customer’s program.
• Coordinates the generation of updates, reports, protocols and governance packages, ensuring scientific and executional accuracy.
• Ensures appropriate technical and project escalation occurs when needed.
• Participates in meetings by telephone with the customer.
• Ensures readiness of development outputs (materials, technical documents and work plans) and drives deliverables with the team for manufacturing readiness (STR, MPR, MACO, materials, methods, etc.).
• Ensures that production campaigns (if required) are supervised by the work cell.
• Is the primary contact for customers and auditors concerning the scientific aspects of projects.
• Contributes to project technical evaluations for the purpose of new proposal generation.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring, and performance management.

• Functional knowledge of project management, process chemistry, GMP and EHS guidelines
• Able to independently judge the scientific aspects of the chemistry of, and solve the problems in, projects, and able to prepare and lead a work plan
• Capable of leading (small) project teams
• Has understanding of the mechanism of operation of the organization and effective planning of projects and production campaigns
• Able to work with employees at all levels within the organization
• Strong written and oral communication and presentation skills
• Directly leads team of approximately 7 - 10 direct reports
• Participates in the hiring process of other employees
• Makes hiring decisions of other employees
• Schedules and reviews the work of other employees
• Ensures accuracy and relevance of assigned training curriculum
• Drives timely completion of training for employees to meet regulatory requirements
• Coaches, mentors and develops other employees
• Prepares and delivers performance evaluations of other employees
• Makes recommendation of disciplinary actions of other employees

• Bachelor’s Degree (Chemistry, Pharmaceutical Sciences, Engineering, or related) required.
• Master’s or Doctorate Degree preferred.
• 5-7 years of related experience required; 12+ years preferred.
• Prior pharmaceutical experience required