This job is archived
(Archived) Global Manufacturing Technologies Sr. Manager/Director
Job Description
Position Summary
The GMT site leader provides leadership for the Production Scientists, and Technical Project Managers who have responsibility for the technology transfer of new products from VMRD into the sites, including early stage support and sourcing through regulatory filings.
The teams also support technology transfer of commercial products to and from internal and external sites. The GMT site lead has responsibility for biological and biopharmaceutical products in the responsible site.
The GMT site lead has ownership for supporting the performance of the current processes and ensures that the GMT team are monitoring and managing the performance of all the biological and biopharma processes on site.
The GMT site lead sits on the Site Leadership team and represents Site GMT on all cross site activities, as well as ensuring that the GMT team are aligned with the colleagues across the site.
Position Responsibilities
- Ensuring that the technical team are appropriately resourced to support the New Product’s in development coming from VMRD, whose main responsibility is to ensure scale-up of the processes and process robustness.
- Assigning team members to work side by side with VMRD to transfer the appropriate products to your site.
- Take ownership of supporting the performance of the manufacturing processes, including regular review of manufacturing data. Process monitoring to ensure manufacturing remains in control of the processes, including setting upper and lower control limits on the processes.
- Manage improvement processes for reducing scrap on site related to weak manufacturing processes or analytical process.
- Manage improvement process for improving MUV through process yield improvement projects.
- Support the site on PPV improvements, where technical studies/inputs are required.
- Support the site on product impact assessments or investigations, where required.
- Ensure team members have the skills to determine future needs of the site, based on current understanding of the processes in development. Promote green belt and black belt project completion and certification.
- Manage the team and ensure that the team is committed to delivering for VMRD and manufacturing.
- Develop a GMT team with the appropriate skills to perform their roles.
- Work with other team leaders on sharing of technical knowledge across the businesses supported by the team.
- Responsible for establishing team goals and objectives and holding team accountable for achieving the goals and objectives. Responsible for ensuring the team goals align with VMRD, GMT, and site goals and objectives.
- Managing the GMT Site Budget to ensure that GMT spending is controlled to the budget targets.
- Manage the site administrative aspects of leading a functional group on site.
- Ensure team is in compliance with training requirements.
- Ensure team is working in a safe manner and in a safe environment.
- Identify new technologies which may be used in Quality Control Laboratories and Manufacturing
Education and Experience
- BS degree in Biology/Microbiology, Bioscience Engineering, Chemistry or Chemical Engineering is required.
Experience
- 5 years plus of leading a team of individual contributors, with a proven ability to ensure team are focused on execution.
- 14 years (12 years with MS) of industry experience, with a minimum of 5 years directly applicable job experience in vaccine and biopharmaceutical manufacturing.
- Understanding of regulatory requirements for veterinary biologics manufacturing and development
- In-depth technical knowledge of analytical testing, cell culture, fermentation, aseptic vaccine drug product formulation and fill finish, including lyophilization processes and the equipment used.
Technical Skills Requirements
- Strong interpersonal skills and ability to interact across divisional boundaries.
- Excellent communication skills. As GMT leader it is vital that you and your team communicate with all stakeholders, including site management, manufacturing, Quality, Quality Control, VMRD, and GMT Global.
- Ability to motivate team and to keep them focused on the needs of the business.
- Strong delegation capabilities, holding colleagues accountable for commitments.
- A self-starter who identifies inefficiencies in business processes and develops simple processes to support colleagues in getting their job done.
- Technical trouble shooter who can guide his team through problem solving.
- Holding team accountable for meeting project timelines.
- Ability to prioritize projects based on the changing needs of the business.
- Demonstrated excellence in planning and organizational skills.
- Critically review projects to ensure that resources are being used in the most efficient way.
- Ability to lead or support multiple teams, groups, functions, key projects or processes.
- Must be willing to contribute to the development of the culture of the site and take an active role in improving the performance of the site as a whole.
- Comprehensive demonstrated skills in communicating (oral and written) effectively with diverse individuals/groups; facilitating trust, understanding, growth and continuous improvement and developing effective empowering and enabling employee, business and customer relationships.
- Demonstrated ability to work in diverse environment and internationally.
Physical Position Requirements
- Lifting
- Sitting
- Travel to Lincoln, NE and potential international travel
- Standing
- Walking
- Gowning into production areas
- Work some weekends due to experimental designs