Process Science Manager

About the role

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.

Responsibilities

• Design, develop, optimize pharmaceutical processes for manufacturing of allergenic source materials, while providing the required CMC documentation, to transfer and implement the manufacturing processes in production.
• Supervise 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.
• Work closely with our Production and Quality Assurance Departments on trouble shooting and improving existing processes.
• Develop the Process Science team and the team members' skillsets and areas of expertise.

Requirements

• Bachelor's degree in biological science, biochemistry, chemistry or related field and a minimum of 5 years 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.

Qualifications

• The successful candidate will have:
• 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.

Skills

• Strong understanding of pharmaceutical process development including EU and US guidelines.
• Proven development experience.
• Experience in process development and DOE.
• Excellent quantitative skills and working knowledge of statistics.
• Experience supporting production teams through deviation investigations, process trending, root cause analysis, and process optimizations.
• Experience working in a regulated manufacturing environment, preferably pharmaceuticals.
• 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.

Benefits

• 2x a week, on-site catered lunches.
• On-site workout facilities.
• 401K company contribution and matching.
• Paid vacation.
• Paid sick time.
• Comprehensive health insurance.
• Flexible work schedule.
• Professional development opportunities.

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time position with flexible work schedule.

Benefits

• 401K company contribution and matching.
• Paid vacation.
• Paid sick time.
• Comprehensive health insurance.
• Flexible work schedule.
• Professional development opportunities.