SUMMARY OF POSITION
The Method Development and Analytical Services (MDAS) Senior Scientist is an expert scientific resource for the MDAS Group within PDTS. The Senior Scientist performs investigations, interprets complex data, develops and justifies approach, provides direction and leads the resolution to overcome scientific and technical challenges facing the MDAS Laboratory. The Senior Scientist identifies critical product attributes, identifies, develops, and justifies methodology and specifications supporting API and finished products under development.
ORGANIZATION STRUCTURE
The MDAS Senior Scientist reports to the Director or Manager of MDAS.
RESPONSIBILITIES
- Responsible for the technical and scientific integrity of the work performed by the MDAS laboratory group within PDTS, ensuring that work is completed in a scientifically sound manner.
- Develop and drive the approach to product development, analytical development, troubleshooting and implementation of new technologies to enhance integrity of the finished scientific work.
- Hands-on laboratory bench work and sample testing as required to support development of pharmaceutical products. This includes but not limited to performing assay, related compounds testing, dissolution, uniformity and other tests to characterize and demonstrate product performance.
- Define the development and validation strategy for all analytical methods necessary for commercialization of pharmaceutical products.
- Build and leverage cross functional collaborative relationships to achieve shared company objectives. Promote collaboration to both internal and external team members.
- Seeks opportunities to add value by developing and implementing strategic objectives related to the scientific and/or quality improvement of the department work product.
- Keep abreast of emerging regulation and industry trends and identify and define innovative strategies to achieve industry requirements and business objectives.
- Sorts through complex data, gathers viewpoints, identifies important issues, and thinks through alternatives to formulate practical solutions to challenging problems.
- Utilizes statistical methods to assess process control, evaluate complex data, and ascertain cause/effect relationships.
- Investigate non-conformances to determine root cause, develop and implement corrective and preventive actions as required. Document investigation thoroughly for scientific and compliance record.
- Serve as a “Role Model” setting and holding the standard for the department by demonstrating exemplary leadership, urgency, scientific prowess, planning and communication behaviors in all work activities.
- Leads teams through the decision making and problem-solving process.
- Continually providing mentoring, training, guidance, and instruction to laboratory staff to increase theoretical knowledge and practical skills to build technical mastery in MDAS.
- Confers with Regulatory Affairs staff to develop regulatory strategies for negotiating complex regulatory landscape regarding product methods, specifications, chemistry, manufacturing, and controls.
- Makes safety a cultural norm by role modeling safety behaviors and providing corrective feedback and actions for safety outages.
QUALIFICATIONS
- MS in Chemistry or relevant science plus 10 years of progressively responsible experience in pharmaceutical analytical laboratories or a Ph.D. in Chemistry or relevant science plus 7 years of progressively responsible experience in pharmaceutical analytical laboratories.
- Expert in GMP and pharmaceutical industry concepts.
- Expert in analytical techniques employed in testing drug substance and drug product, particularly related to solid oral dosage forms.
- Strong analytical aptitude, ability to comprehend and apply scientific theory and analytical techniques to solve problems.
- Advanced computer skills specifically in Microsoft Word, Excel, and statistical applications.
- Refined written and verbal communications and presentation skills.
- Strong organizational skills, ability to manage and complete assigned projects on time.
GMP DECISION-MAKING AUTHORITY
The MDAS Senior Scientist has authority to set direction, perform, and manage efforts supporting method development, validation, and other requirements associated with the development and commercialization of pharmaceutical products.
This role will offer a base salary that is commensurate with experience and demonstrated skills in the $90,000 - $100,000 range.
“An Equal Opportunity Employer, including disability/vets.”
