Principal Scientist, Analytical Development
North Brunswick Township, NJ 
Share
Posted 17 days ago
Job Description
Oyster Point Pharma, Inc (Delaware corp)

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

  • Access - Providing high quality trusted medicines regardless of geography or circumstance;

  • Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

  • Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how the Principal Scientist, Analytical Development role will make an impact:

Key responsibilities for this role include:

  • Conduct analytical method development, validation, and project support. Identifies technical challenges during analytical method development and performs method troubleshooting.

  • Manage CMO/CRO analytical project resources as required such as contractors and contract laboratories.

  • Manage technical direction of analytical projects; identify key deliverables and next steps and communicate to the team.

  • Responsible for data review, analysis, and interpretation from a variety of sources. Provide accurate summaries and make recommendations to stakeholders with scientific rigor.

  • Identify and implement new techniques and instrumentation to expand internal capabilities.

  • Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents.

  • Performs the assigned analytical tasks with minimum supervision in support of product development and clinical trial materials.

  • Performs activities within the assigned timelines and in compliance with cGXP's, regulatory requirements, and company practices and procedures.

  • Responsible for the design and conduct of studies in accordance with company and regulatory standards to facilitate new product development.

  • Manage day-to-day laboratory activities for analytical equipment, including sourcing consumables, troubleshooting, maintaining equipment and calibrations with various vendors.

The minimum qualifications for this role are:

  • Degree in chemistry, pharmaceutics, or related field; advanced degree is a plus.

  • 10+ years experience in analytical method development, validation and drug product development activities regulated by FDA.

  • Working knowledge of standard Office tools (MS Office, MS Project, Excel, Visio, SharePoint).

  • Ability to work well both independently and with a team.

  • Excellent written and verbal communication skills.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.


Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
10+ years
Email this Job to Yourself or a Friend
Indicates required fields