Are you an inspirational leader with an appetite for positive change management?
Are you an expert in drug substance and drug product manufacturing processes for Biologics Cell Culture?
Can you be the leading interface between CMC and Manufacturing?
Fraser Dove International is exclusively supporting a Global Pharmaceutical organisation seeking an exceptional leader to aid in the transformation of its Biologics platform.
Discover more about our Global Head Manufacturing Science & Technology opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Global Head of Manufacturing Science & Technology, you will be measured against the following objectives:
1) Establish and lead the Global Manufacturing Science and Technology function.
2) Manage the interface with CMC project management, CMC regulatory and manufacturing.
3) Define the strategy for the introduction of improved drug substance and drug product manufacturing processes.
What you will do:
As the Global Head of Manufacturing Science & Technology, your duties and responsibilities will include:
- Defining the strategy for the introduction of improved drug substance and drug product manufacturing processes for biologics manufactured from cell culture from a conceptual idea to filing together with the responsible product project manager.
- Establish, lead and manage a team of technical staff, engineers, scientists and lab managers with expertise in upstream/ downstream manufacturing, analytics, formulation development and fill and finish.
- Establish state-of-the-art scale-down lab capabilities at the biologics hub in Basel.
- Managing the interface of the Manufacturing Science group with CMC project management, CMC regulatory and manufacturing.
- Establishing a global state-of-the-art formulation platform for therapeutic proteins including analytics (in collaboration with process development).
- Support end-to-end development set up with a focus on the transition from late-stage-development towards lifecycle management post-launch.
- Act as a global process owner leading process oversight and technical direction.
- Lead a cross-functional biologics centre of expertise accountable for key technology platforms supporting drug/biologics pipeline.
- Provide management of resources dedicated to technical activities and establish close collaboration with other MS&T operating units, external industry biologics consultants and biologics academic partnerships globally.
- Provide technical capabilities to the functions of manufacturing, quality, regulatory, engineering, and external supply (EMOs) as well as technical solutions/knowledge across the internal and external biologics networks.
- Ensure product stewardship through end-to-end technical oversight of the manufacturing processes at all stages of the product commercial lifecycle.
- Ensure Process Performance Qualification (PPQ), Continued (Ongoing) Process Verification (CPV/OPV) and Annual Product Reviews (APRs)/Product Quality Reviews (PQRs/APRs).
What you will bring:
These are the skills and experience you will need to succeed as the Global Head of Manufacturing Science & Technology:
- Long-term experience, with at least several years of senior level management experience in the Biologics or related industry.
- Passion to innovate, the power to change reporting relationship (i.e. leading through influence).
- Knowledge of key biologics manufacturing technologies.
- Demonstrated ability to manage multiple functions and business activities and to drive for results and lead innovation.
- Strong change management skills and demonstrated ability to simplify and improve business processes.
- 10+ years of combined experience in the development and manufacturing of proteins from cell culture.
- Established track record as an efficient manager.
- PhD level education in the field of biotechnology, biochemistry, animal cell culture.
- Excellent scientific background and presentations skills.
- Leadership skills with a proven track record of leading a team (> 5 years).
- Project management skills with a proven track record (> 3 years).
- Strong regulatory background.
- Experience in introducing process changes post-launch.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Competitive Short and Long Term bonus structure.
- Market leading Private Health benefits.
- Private Pension.
- Sports Club Membership.
- Subsidised Canteen.
Got what it takes?
To apply for the Global Head of Manufacturing Science & Technology, click the ‘Apply’ button below or contact the Executive Search Consultant – Luke Brown – on +44 (0)203 355 7050.
- All preselected Applications will be forwarded and processed by our Swiss Partner, SDE Services AG, according to Swiss law.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.