Process Development and Operations Support Manager
About The Position
ALK Abello' Source Materials, Inc., a leading manufacturer of quality allergenic biological source materials, and a member of the global ALK-Abello' group of companies, is recruiting for our open Process Development and Operations Support Manager. This is a regular, full-time, benefits-eligible position. Join our stable and growing company and provide leadership and expertise to our workforce located in our 150,000 square foot facility in Post Falls, ID. As 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.
Requirements
- Bachelor's degree (Master or Ph.D. preferred) in biological science, biochemistry, chemistry or related field and a minimum of 8 years of relevant experience (5 years if Master or Ph.D.)
- 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.
Nice To Haves
- Because allergenic source materials are biologics it will be an advantage to have experience with protein and immune-chemical methods and characterization tools
Benefits
- 401K company contribution and matching
- paid vacation
- sick time
- free catered lunches 2x a week
- on-site workout facilities
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
501-1,000 employees
