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Sr. Development Scientist - Analytical/Project Management

Application Deadline: May 31, 2019

Location: Schaumburg, ILLINOIS, USA

Job Summary I Overv iew:

This position is responsible for the management of product development and project management for self projects and assisting PD/PM project teams.

Success of this role would be measured primarily by the following:

  • Address technical issues that arise during product development, conduct project review, planning and tracking of technical operations.

  • Assist Project Management with various activities across analytical development I product development, manufacturing, FDA submissions, review (CRLs and IRs) and approvals to ensure progress against milestones of multiple projects at various domestic and international sites.

  • Establish close collaboration with members of the Quality and Regulatory teams, and external partners to ensure that information, analyses and recommendations are available to make the right decisions in a timely manner.

  • Manage technical discussions, activities and documentation for all member of the Project Management Team, review issues and documentation (protocols, reports) for analytical I product development, ANDA submissions, and approvals to ensure progress against milestones of multiple projects at various domestic and international sites.

  • Assist in timely ANDA approvals through efficient development activities and quality submissions based on current FDA requirements.

  • Cross functional interactions with CDOs/CMOs/CDMOs/BD/Marketing/GAM or internal resources teams towards development of R&D/manufacturing of exhibit and PV batches.

  • Participate in meetings and discussions with external partners, actively propose technical solutions to address complex issues under very tight timelines.

Key Duties & Responsibilities:

  • Manage I address analytical technical questions for Sagent's Project Management team, cross functional l teams, and designated partners to ensure that information, analyses and recommendations are available to the team, partners and senior management in a timely fashion.

  • Act as the liaison between Sagent and designated partners, developing relationships which enable this position to influence partners' actions and decisions.

Knowledge & Expertise:

  • Knowledge of the Pharmaceutical industry analyt ical I product development to ensure analytical methods are developed with QbD format and filed in ANDA/NOA on schedule with all current FDA and cGMP requirements .

  • Strong technical experience of the parenteral pharmaceutical industry with knowledge to develop complex products.

  • Knowledge of analytical method developmenUvalidation and manufacturing planning, Batch Records, Investigations, and Deviations Review a plus. Expertise of cGMP regulations as well as understanding of Quality and Regulatory implications of current technical activities.

  • Solid experience developing, cultivating and managing internal and external relationships with people at all levels of management.

  • Cross cultural competency - experience working with global suppliers or working internationally in another country may be required. Understanding of how to communicate a clear message and manage people and projects in other countries is required.

  • Able to work in a cross-functional, matrix team environment with a flexible team-oriented perspective.

  • Thrives in a rapidly changing , fast paced, entrepreneurial and growth oriented business culture.

  • Strong interpersonal skills including verbal and written communication.

  • Ability to manage multiple activities in a fast-paced, changing team environment essential for a generic pharma company.

  • Solid computer skills and managing presentation to the Management team.

Minimum Qualifications/Experience:

  • Advanced degree in Analytical Chemistry or Ph.D. with 5-7 years of experience in parenteral drug development of drug products required.

  • Analytical I Product Development, Manufacturing Operations and/or Microbiology environment in the Generic Pharmaceutical Industry focused in parenteral dosage forms preferred.

  • Project Management skills desired to lead your own projects.

  • Strong interpersonal communication skills required - verbal, written and presentation.

  • Willing to travel domestically or internationally as needed up to 10%.

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