1 Method Development and Analytical Services, Senior Scientist Job in Berlin, NY
Scientific Search is Hiring a Method Development and Analytical Services, Senior Scientist Near Berlin, NY
What You Can Expect To Be Doing
- Reports into the Director or Manager of MDAS.
- Be an expert scientific resource for the MDAS Group within PDTS.
- Perform investigations, interpret complex data, develop and justify approach, provide direction and lead the resolution to overcome scientific and technical challenges facing the MDAS Laboratory.
- Identify critical product attributes, identifies, develops, and justifies methodology and specifications supporting API and finished products under development.
- 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.
- Seek 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.
- Sort through complex data, gather viewpoints, identify important issues, and think through alternatives to formulate practical solutions to challenging problems.
- Utilize 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.
- Lead 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.
- Confer with Regulatory Affairs staff to develop regulatory strategies for negotiating complex regulatory landscape regarding product methods, specifications, chemistry, manufacturing, and controls.
- Make safety a cultural norm by role modeling safety behaviors and providing corrective feedback and actions for safety outages.
- 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.
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Job Summary
Full Time
Ambulatory Healthcare Services
$91k-116k (estimate)
07/14/2024
10/09/2024
scientificsearch.com
CHERRY HILL, NJ
25 - 50
1983
ALLEN C ZECHOWY MDPHD
<$5M
Ambulatory Healthcare Services
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About Scientific Search
Scientific Search is a leader in the placement of technology professionals. Our technology areas of specialization include engineering, pharmaceutical & biotech, market research and information technology. Our client base is predominately centered in the corridor stretching from Philadelphia to New Jersey and the New York metropolitan area. We do, however, conduct a significant portion of our business outside of our primary market territory, both regionally and nationally. We are a full service employment agency offering multiple staffing options. From contract placements to direct placements ...and everything in between, Scientific Search works with employers and technology professionals to find the perfect solution. Scientific Search was founded in 1983 and has been providing recruiting and staffing excellence for twenty years. We have survived and excelled through a combination of hard work, knowledge and integrity. We are the firm that leading employers depend on to solve their staffing needs, and technology professionals trust to find challenging, rewarding positions. To learn more about Scientific Search, please visit our website at www.scientificsearch.com or call 856-761-0900.
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