Process Development and Operations Support Manager (Process Science Manager)FULL-TIMEAs the Process Development and Operations Support Manager you will be part of the Development Department at our Post Falls, Idaho facility. We are responsible for designing, developing, optimizing pharmaceutical processes for manufacturing of allergenic source materials, while providing the required CMC documentation, to transfer and implement the manufacturing processes in production. The Manager is also responsible for supervising process development studies covering the design of experiment, execution of studies and reporting study results in accordance with 'Good Documentation Practice'. These studies will be carried out with a strong working collaboration with development colleagues located in the headquarters in Denmark as well as ALK's partners worldwide. You will work closely with our Production and Quality Assurance Departments on trouble shooting and improving existing processes. Moreover, you will be expected to develop the Process Science team and the team members' skillsets and areas of expertise.
The successful candidate will have:
- Bachelor's degree in biological science, biochemistry, chemistry or related field and a minimum of 5years of relevant experience.
- Solid understanding of pharmaceutical process development including EU and US guidelines and proven development experience
- Experience in process development and DOE is desirable, including tech transfer and Process Performance Qualification (PPQ).
- Excellent quantitative skills and working knowledge of statistics
- Because allergenic source materials are biologics it will be an advantage to have experience with protein and immune-chemical methods and characterization tools
- Experience supporting production teams through deviation investigations, process trending, root cause analysis, and process optimizations
- Experience working in a regulated manufacturing environment, preferably pharmaceuticals, demonstrating the ability to work with Quality Systems and regulatory requirements such as CFRs, GMP, FDA, OSHA, and European Authority
- Desire to use knowledge to develop others and a general interest in supervising other scientists
- Good facilitation and communication skills
- Ability to divide your effort across multiple projects
- Previous project management experience within cross functional projects
All positions at ASM require the ability to work comfortably and safely around insect venoms, allergens, hazardous chemicals, solvents, and other laboratory reagents.
To learn more about ALK, please visit our website at www.alk.net/us. If this position describes a fit for you, please submit through the link below. No agencies or recruiters please.
https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=86877c6e-0947-43c2-95c[redacted]7b440&ccId=[redacted]716_859&jobId=570714&lang=en_US
