About this role: Head of Formulation & Stability
We are currently hiring a Head of Formulation & Stability for our client, a global pharmaceutical company and one of the largest pharmaceutical companies in the world. The company is known for its global contribution in areas including pharmaceuticals and consumer healthcare products. Our client offers the broadest range of vaccines in the world, providing protection against a wide array of bacterial and viral diseases.
This is a full-time hybrid role. The Head of Formulation & Stability will be responsible for scientific, technical, and compliance-related aspects of assigned projects and ensure that objectives are met. Plan and supervise the execution of development activities to ensure scientific excellence, adherence to advanced technical standards and compliance with GxP status of work. The role will also supervise, train, motivate and empower direct reports to perform assigned tasks as required. They will be the technical expert on the formulation, adjuvant and adjuvanted formulation development and interface as the main technical expert globally for NV projects.
- Managing and developing resources (equipment, technologies, facilities, and people), and providing necessary scientific and managerial leadership to meet project and platform objectives
- Implementing state of the art methods internally or through innovative partnerships and collaborations
- Ensuring compliance of platform deliverables with quality and regulatory requirements.
- Ensuring that project activities related to the unit are conducted with optimum efficiency and quality
- Implementing strategies/goals that align with global R&D strategies and goal implementing plans to maintain improve and develop new competencies, and assessing/obtaining resources (including personnel) necessary to meet current and future goals
- Lead formulation, adjuvant and adjuvanted formulation development in NA Drug Product team
- Provide Formulation and adjuvant expertise for drug product development locally and globally if needed to increase agility of project execution
- Interface as needed with Global Drug Substance (for DS formulation development), AnSci locally and globally for stability indicating assay development and deployment
- Collaborates globally with other formulation peers and scientists to create a strong scientific network in the field of formulation
- Designs and provides oversight on platform's experimental plan in support of projects. Prepares process development reports, scientific publications, and external presentations
- Guarantees the formulation development effective project tactics design across all projects in NA
- As needed, authors, or leads scientists to author regulatory documents for agency submissions
- Ensures the effective best path execution of formulation development, formulation regulatory, quality compliance and safety thresholds of formulation deliverables
- Lead teams of peers and other scientists within or across platforms and manage, develop, and inspire technical staff
- Provides leadership on innovation and technologies and implementation and can act as a sub-domain leader or domain leader for innovation platform
- Provide leadership on formulation, adjuvant and adjuvanted formulation compositions to be transferred to internal departments such as Mtech/VIA and internal groups such as VCDS Global Clinical Supply
- Supervises and monitors compliance with employment and health & safety legislation to ensure that employees work within the policies, procedures, and regulations
- Lead DKMs for responsible projects. Manage responsibilities of direct reports to maximize FTEs and cross-functional team meetings
- Propose, influence, and implement strategies within Global Drug Product Development
- Interact throughout Global VCDS DP, VITA, external industry networks and task forces
- To ensure good scientific and technical leadership within VCDS, keep abreast of the current developments in relevant scientific and technical disciplines and ensure current developments are implemented when appropriate
- Prepare internal and external presentations, patent filings, research manuscripts and review articles as required
- Complete Workday-related approvals, such as absence, overtime et al. in a timely fashion
- Actively communicate with staff any changes or concerns that may impact them (and vice versa)
- In collaboration with Global DP Head, allocate resources according to project priorities and needs
- Ensure project scientists and technical staff complete the work on time and on quality.
- Provide routine performance feedback to staff
- Ensure consistent understanding and application of the Collective Labour Agreement, awareness and alignment of work within the Platform and cross-Platform, when applicable
- Together with Global DP Head, provide additional assignments, and training opportunities to support growth and development of staff
- Coach, engage and energize staff to help improve overall job satisfaction and performance
- Provide guidance, as requested, to staff for their career development and advancement
- Share information and harmonize development within VCDS and other departments such as Research, Manufacturing Technology, Industrial Affairs, Quality Operations, Regulatory Affairs, Clinical/Medical as necessary. Ensure good teamwork and provide high quality deliverables, such as Technical reports, development reports within agreed timeframes. Support regulatory submission by participating in preparation of regulatory submission documents (CTA, IND, CTD)
- In depth knowledge of experimental work and data analysis. Working knowledge of computer skills, scientific writing and presentations, supervisory/management/people development, communication skills, innovative thinking, and a familiarity with strategic planning, balanced judgment, risk analysis and budget process is required
- This is a position with multiple interfaces that will lead the drug product design and development and participate in product know-how discussions with Global Antigen group. Act as CMC DP lead to interact with Global CMC Leaders, Franchise Leaders, cGMP teams, CMOs, AnSci, SQO, MTech/VIA
- University degree in Business Administration with major in Business Management, Ph.D. in Pharmacy/Formulation/Biochemistry/Microbiology/Chemical or Biochemical Engineering or equivalent
- A minimum of 10 years management experience within the pharmaceutical or biotechnology industries
- Entrepreneurship, change and innovation driven attitude
- Effective communication with excellent teamwork
- Company spirit with strategic thinking and balanced Judgment
- Experience with use of technical expertise
- Managing, organization and people development skills
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Your consultant, Michael Leung is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto