The Head of Manufacturing Science and Technology, part of the PDTS (Process Development and Technical Services) organization, is responsible for defining and prioritizing the on-going developments/improvements, problem solving processes and projects within the plasma business. He/She is in close contact with the manufacturing/quality organizations, and with relevant process experts. Key in this role is the development and direction of strategies that will drive the achievements of the companies’ business objectives.
Essential Duties and Responsibilities
Manage and develop the Technical Services group, leading a team of approx. 20 employees
Assure process robustness and supply reliability by controlling the manufacturing process life cycle from process / product development and authority submission to routine production
Responsible for providing a reliable yield status (actual data) and accurate yield forecasts for all plasma products together with strategies to meet the yield targets
Develop and direct strategies to drive yield improvement projects, to reduce lead times, to secure the process and to reduce deviation.
Contribute to long term strategic planning
Evaluate the suitability of new technologies for the implementation in manufacturing and work with Process Science and the plant operations team to ensure successful transition to the manufacturing floor
Ensure compliance with current GMP and other regulatory requirements
ApplyLean, Six Sigma and DMAIC methods to improve the manufacturing processes and to determine causes of product failures or process shifts
Guide and monitor projects/tasks/initiatives and ensure timely implementation
- Broad knowledge and experience within the GMP environment, Lean and SixSigma and regulatory affairs
- Very strong and proven leadership experience and capability
- Very successful track record of change management projects and processes
- High level of customer orientation and organizational skills
- Flexible in mind / out of the box thinker
- Enthusiastic, decisive, motivating and convincing personality
- International background appreciated
- Excellent communication skills, verbal and written communication skills
Education and/or experience
Master or PhD degree in technical / scientific education, preferably biochemistry, biotechnology or pharma – process engineering is essential
At least 10 years professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology
- Must be able to lift, push, pull and carry up to 30 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold, wet environment
- Must be able to work multiple shifts, including weekends.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
Req ID: R0021193