How will you make an impact?
This role will lead process engineering for an exciting new business unit focused on microbial manufacturing. Successfully manages departmental resources in order to deliver on customer commitments and expectations. Ensure process equipment deliveries, ISO-Class cleaning, and buffers & media deliveries in support of clinical and commercial GMP plasmids. Demands are met in accordance with established quality, efficiency and regulatory standards. This involves oversight of all resources including personnel, equipment, and capital. Collaborative interaction with peers both within and outside of department is necessary for success. Management and development of direct reports is also critical to this role. Demonstrated leadership inside of the department is also an expectation.
What will you do?
- Strong understanding of microbial production processes and the production environment including upstream, downstream, PD, scale up and filling
- Relevant technical knowledge
- Strong understanding of cGMP and other regulatory requirements
- Mechanical & technical ability/aptitude
- Analytical problem solving skills
- Good business decisions using both cost and risk analysis
- Organized, Efficient, and Results oriented
- Good people coaching and development skills
- Good communication and presentation skills (verbal and written in English)
- Basic computer including report writing and graphing
- Quality and/or Financial software (SAP, NextDocs, ComplianceWire, etc) skills a plus
How will you get here?
- Bachelor degree with 7-10 years industry experience (preferably in a cGMP environment) or equivalent combination of education and experience
- 5-10 years of proven Management experience
- Demonstrated leadership skills
- Able to sit, stand, walk, lift, push, pull
- Able to gown per cGMP requirements and work in a gowned condition for extended periods of time in a cleanroom environment (including various temperatures and noise conditions)
- Able to work with chemicals and don appropriate PPE
- Able to hear, see, smell
- Able to work potentially long, flexible hours and be reachable for consultation 24 hrs. per day.
- Startup experience a plus
Knowledge, Skills, Abilities
- Unquestionable integrity
- Strong leadership
- Lead change
- Handle multiple tasks, issues, projects
- Work independently and as a part of a team
- Handle difficult situations with tact and diplomacy
- Distill and solve issues
- Build agreement via collaboration