Have you ever thought "It would be cool to know the work I do on a daily basis directly impacts the lives of people all around the world"? If so, we could have the perfect opportunity for you!

Simply put, Particle Dynamics creates pharmaceutical, nutraceutical, and over the counter products that will improve the health of consumers around the world! We offer growth and training opportunities to individuals looking for a change of pace from the big manufacturing facilities. So, what makes us stand out from others?

• We are smaller in size, so we have a tight knit group of employees - it's like family!
• Employees start out with paid time off - no waiting period to take time off!
• We offer a highly competitive benefits package with coverage starting the first of the month following your hire date - benefit coverage starts almost immediately!
• Our pay rates are highly competitive - we pay more for experience and high performers!
• We are a pharmaceutical manufacturer - all our production and packaging lines are climate controlled!
• We work hard but don't require employees to work 6-7 days a week - we promote a healthy work/life balance!

This is a day shift position reporting directly to the VP of Technical Operations

Summary of Responsibilities:

• Conduct formulation and process development projects from early-stage development and small-scale operations through scale-up and full commercial production
• Engage in feasibility and idea generation discussions to provide customers solutions regarding their products and challenges
• Write technical portion of product development proposals in collaboration with business development group.
• Chair technical updates on development project with customer's representative.
• Create and manage project timelines individually or leading a project team
• Design and execute stability protocols for new products in development as required
• Collaborate with customers and business development to discuss Particle Dynamics' capabilities and partner with them regarding customers' needs
• Support commercial group to develop business case and costs for new products
• Plan, manage, and coordinate the processes of risk analysis, quality-by-design, process development, method development, process scale-up and optimization, and technical transfer activities for new products to ensure they meet expected requirements for quality, cost, and manufacturability
• Write manufacturing batch records, experimental protocols and reports, process development reports, product and process assessments, technical transfer reports, test methods, SOP's and other documents, as required by management
• Provide input and technical assistance to operations, and quality assurance, with respect to the validation and launch of new and reformulated products
• Provide technical assistance related to troubleshooting process issues or improving process/product performance
• Lead and/or participate in method development, process scale-up, optimization, and technology transfer activities
• Support other members of the PPIC group
• Complete projects within the specified time periods and within applicable cGMP's, GLP's, company policies, and standard operating procedures
• Participate in the purchase of new equipment for research and development and operations and assist in the installation and qualification of new equipment and/or facilities
• Assist Supply Chain function in selecting and qualifying new raw materials.

Position Qualifications:

• Has in depth knowledge of pharmaceutical, nutraceutical, and food compliance regulations
• Excellent analytical and problem-solving skills
• Project management skills
• Strong communication skills (oral and written)
• Proven technical writing abilities
• Strong teamwork orientation
• Maintain state-of-the-art knowledge with respect to manufacturing technology through professional meetings, seminars, trade shows, industrial visits, publications, and associations
• Strong computer skills MS Office, Excel, Word, MS Project, Visio, Minitab, etc.

Education/Experience:

• Bachelor of Science in Chemistry or related field
• 5 years' experience in product/formulation development within GMP facilities preferred (10 yrs for Sr level)
• Professional product development experience
• Prior experience writing SOPs, batch records, and work instruction
• Prior experience with qualifications and validation strongly preferred
• Prior experience with customer technical support and troubleshooting
• Prior experience with customer facing product development preferred
• Experience in project management within a team framework

Benefits:

• Health, dental, vision, STD/LTD and life insurance effective the 1st day of the month following a new employees hire date
• 401k match - 4% of 5% the employee contributes (100% on first 3%, 50% on next 2%) - immediate vesting!
• This position is eligible for the following time off yearly - 120 hours of vacation, 40 hours of sick, 16 hours of personal time - vacation and personal time are available upon hire!
• Uniforms, safety shoes and safety glasses provided to employees by the company
• Employees are eligible for paid holidays upon hire - 10 ANNUALLY!