ATS-Principal Scientist

Summary:

Accountable for the development and transfer of analytical/bio-analytical methodology, for providing leadership to site lifecycle management activities associated with Combination Drug Products and Devices , technical products transfer support, transfer/optimization of functional test methods and the management of systems for the ATS-QC laboratories at BMS Manati Operations. The incumbent will also be responsible for leading critical analytical investigations and projects, Bio-Analytical research/troubleshooting and performing Statistical Analysis in support of investigations, studies and projects. In addition, serves as the Analytical Technical Services (ATS) subject matter expert (SME) for the pharmaceutical/biologics combination products.

Responsibilities:

1. Conceives and designs, executes or evaluates and interprets experimental strategies to support combination products activities.
2. Provides scientific guidance and leadership in critical Analytical Investigations.
3. Provides leadership to Combination Products projects activities including the execution of equipment installation and validation activities, design specification documents, generation of equipment SOP.
4. Develops other members of the ATS organization in the technical and regulatory areas associated with devices/combination products.
5. Defines technical strategy of the ATS group, maintains close coordination and networking with Research/ Analytical Development groups and Device Operations and ensure the success of the ATS organization by leading timely and successful introduction of new products/devices into the site.
6. Supports all site Initiatives and any other assignments based on business needs.
7. Leads the execution of Method Qualification of Combination Drug Products including assuring documentation, specifications and regulatory requirements are met.
8. Represents Manati Analytical in Medical Device site sub-team on the new product Manufacturing Launch Teams to ensure successful project execution according to established objectives.
9. Utilizes best in class project management methodology to manage multiple devices/combination products projects concurrently.

10. Collaborates in the development/ execution of the drug delivery devices components and equipment initiatives.
11. Keep abreast on the current pharmaceutical and Medical Device Industry technology and trends and understand their impact on BMS Medical Device strategy and site operations.
12. Coordinates internal/external resources to complete projects on time, within budget and exceeding quality/environmental/customer standards.
13. Supports the Device Operations with technology assessment.
14. Develops, validates and transfer analytical methodologies for new products as well as life extension products
15. Participates on project teams to ensure the Analytical Technical Services representation on technical issues.
16. Generates and review scientific data and reports and ensures consistency and accuracy.
17. Interfaces with other BMS groups in R&D and GM&S on project issues to build collaboration and harmonization within the development and manufacturing network at BMS.
18. Ensures that all activities are performed in compliance with federal and local regulatory agencies.
19. Participates in the development and administration of the functional area Budget.

20. Manages associates within the ATS team and participates on project teams to ensure the Analytical Technical Services representation on technical issues.

This is intended to be a general job description and should not be construed as all inclusive.

Knowledge/Skill:

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• PhD in Chemistry, Biology or Pharmacist with (5) years experience or MS in Chemistry, Biology or Pharmacist with (8) years of experience in the pharmaceutical industry in a chemical, analytical development, analytical instrumentation or pharmaceutical science function.

• Experience in the Pharmaceutical and Medical Device Industry with an advance and thorough scientific knowledge related to analytical and chemical science
• Strong cross functional perspective, leadership and influencing capabilities within a matrix organization
• Knowledge of the pharmaceutical industry and applicable regulatory requirements on devices/combination drug products (FDA CFR 21 Part 820 )
• Experience in writing and executing testing protocols and drafting reports
• Ability to manage multiple projects and work on multi-functional project teams
• Ability to travel to different BMS sites and work with minimal supervision
• Knowledge of project management methodology
• Strong written and verbal communication skills
• Team oriented with excellent interpersonal skills
• Excellent and effective communication skills in both English and Spanish
• Strong analytical and strategic thinking skills
• Ability to align stakeholders to execute against the strategy
• Goal oriented and ability to complete tasks in a timely fashion
• Excellent analytical and problem solving skills
• Leadership skills are essential.

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