The Director of Manufacturing Purification is responsible for 24/7 manufacturing activities related to purification processes for the manufacture of UPB. Execute the manufacturing of DS from UPB to DS freeze
Develop and sustain consistency across MA site purification operations Deploy aligned Operational Excellence methodologies throughout manufacturing operations to meet quality and efficiency targets for MA site Deploy Manufacturing goals in line with overall Site Goals and Bios OpU agenda
- According to LEX Site supply plan
- According to Quality systems and regulatory requirements
Develop talent and capabilities of the Manufacturing teams and individual talent
- Ensure scheduling is appropriate to meet S&OP plan
- Own and manage Operational budget to target
- Support annual shutdown
- Ensure cultivation of right technical expertise
- Develop and sustain environment of cross functional teaming
- Develop and sustain opportunity for high performing individuals to succeed
Provide support for portfolio management.
- Develop and sustain environment of continuous improvement
Maintain a state of inspection readiness
- Meet Capital budget
- Sponsor high priority cross functional projects
Maintain and promote a safe working environment.
- Maintain accountability for facility and process inspections
The Director is a member of the MA Site Manufacturing team, and is accountable to participate in and contribute to appropriate cross functional governance teams. Responsibilities:
In collaboration with the Head of Manufacturing develop goals and drive and monitor performance against those goals, objectives and KPIs.
Lead the respective manufacturing organization to ensure that production targets and budgets are met, that product and processes comply with cGMPs, product licenses and corporate policies, that quality documentation is complete and on time, and regulatory inspections are managed through satisfactory completion.
Develop organizational capabilities throughout the manufacturing organization to ensure continued staff development.
Provide technical expertise for the resolution of issues in the purification areas.
Promote and maintain a safe work environment. Education & Experience Requirements:
Bachelor's degree in Biology, Chemistry, Chemical Engineering or related field with a minimum of 12 years relevant experience or Master's degree in Biology, Chemistry or related field with a minimum of 7 years relevant experience
7 to 10 years of progressive management experience leading large team(s) in a complex bio-processing manufacturing environment.
Knowledge of cGMPs, other regulatory requirements and Intermediate/DS/API processing is required.
Strong communication and interpersonal skills are essential.
Strong comprehension of value-based production improvements Other Requirements:
Must establish a presence as the leader of the manufacturing area at 205ABP, 200SW, 300SW and 400SW. As such must be willing to travel between, attend meetings and develop relationships within each plant.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.