Staff Scientist Marketed Product Support (Mps)

Kindeva Drug Delivery
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
Job Description
Marketed Product Support (MPS) is a global group of subject matter experts with skillsets to handle issues related to all Kindeva manufactured Marketed Products. MPS provides non-routine technical support for Inhalation Drug Delivery (IDD) Commercial Finished Products (Oral Press & Breathe and Autohaler Products, and Nasal Products) and support for Transdermal Drug Delivery (TDD) Commercial Finished Products. The position of Staff Scientist will work collaboratively with cross functional team members on projects that range from small to large. The successful candidate will have a well-rounded skill set, preferably with a base in Analytical Chemistry, act as a leader, and will be able to evaluate complex issues and organize them into clear instructions for successful outcomes. Strong written and verbal skill are key traits as well as the ability to evaluate and trend data.
Key Responsibilities Include:

• Support activities to qualify changes to current Marketed Products, including raw materials changes or discontinuations
  • Conduct, write and route risk assessment reports, as well as other various types of protocols and reports
  • Participate and possibly lead supplier selection activities for vendor changes
  • Participate in change management and complete action items assigned though change management
  • Evaluate and graph data and conduct statistical analysis and incorporate into reports, presentations to customers, etc.
  • Support in project planning WBS and track project activities using MS project
  • Conduct or lead analytical testing and data review
  • Support creation of statement of work
  • Works with Plan Operations to determine and support qualification activities
• Leads technical transfers; writes crossover protocols and reports, including statistical analysis of data and determination of acceptance criteria
• Leads and participated in Change management activities which may include
  • Writing and revising specifications, analytical methods, SOPs, and other documents
• Acts as technical SME on projects, often talking and creating/presenting technical approach to External and Internal stakeholders
• Works with Regulatory to write submissions, respond to agency questions and deficiencies
• Works closely to Quality Control and QA on OOS/OOT investigations as well as Analytical Method Life Cycle Management
• Works closely with Plant Operations to incorporate Process Improvements
• Provides support to projects that are outsourced to external vendors and work with external persons to problem solve and implement corrective actions
• Provide technical support for Raw Materials (Active Pharmaceutical Ingredients & Excipients) and Intermediates.

Position Qualifications:

• Bachelor's degree in Chemistry, Engineering or related technical field.
• 7+ years' experience with proven problem-solving abilities
• Proven record of excellent technical writing and verbal collaboration skills
• Knowledge and experience with Kindeva Marketed Product is a plus
• Previous participation in Drug Delivery new product development, tech transfers, and commercial operations is preferred

California residents should review our Notice for California Employees and Applicants before applying.
Covid-19:
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.