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API Technical Manager

Application Deadline: November 30, 2019

Location: SCHAUMBURG, IL, USA

Job Summary / Overview:

This position is responsible for managing API technical activities, communications and projects in direct support of Sagent API management. Directly responsible for managing and coordinating all API technical activities for new product development, commercial, and API alternate sourcing.

Success for this role would be measured primarily:

  • Completion of all projects on schedule and within budget.

  • Participation in meetings and working in cooperation with internal and external partners to address technical issues that arise during product development and commercial operations.

  • Establishing positive working relationships outside API vendors, external partners, and with internal partners and colleagues.


Key Duties & Responsibilities:

  • Work together in cooperation with API vendors, CMO’s/partners, and internal Sagent and/or Omega teams (Regulatory, Project Management, Alliance Management, and Supply Chain) to coordinate and manage all technical communication associated with API sourcing, procurement and management projects.

  • Manage and coordinate activities with Sagent QA, API vendors and CMO’s/partners in regards to change control associated with API vendor change notices and DMF updates.

  • Manage all technical communication with key stake holders in support of the LCM (lifecycle management) alternate API program.

  • Assist in the coordination of API vendor audits with Sagent QA.

  • Assist in the sourcing and procurement of development API’s, reference standards and impurities.

  • Other duties as requested or required.


Knowledge or Expertise:

  • Knowledge of the Pharmaceutical industry product development, manufacturing and approval process

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

  • Solid problem solving, data analysis and decision making skills

  • Cross cultural competency – experience working with global suppliers. Understanding of how to communicate with, negotiate with and manage people and projects in other countries (China and India preferred) required.

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

  • Strong interpersonal skills including verbal and written communication.

  • Able to negotiate with colleagues and partners to assure deliverables and expectations are met in a timely manner.

  • Ability to oversee multiple and competing projects in a fast-paced, changing team environment.

  • Strong planning and organizational / project / workload management skills.

  • Ability to drive project to completion with minimal oversight.

  • Thrive in, and be able to work in, a fast paced entrepreneurial environment with broad responsibilities.


Minimum Qualifications / Experience:

  • 4 or more years of pharmaceutical industry experience required.

  • Strong technical experience in the pharmaceutical industry, including chemical and analytical methods, processes and procedures. Experience in parentals preferred.

  • Familiarity with GMP, regulatory affairs, logistics, QA, or pharmaceuticals manufacturing.

  • Solid computer skills – proficiency with Excel, Word, Powerpoint and Outlook.

  • Occasional travel domestically or internationally as needed.


Education / Certifications:

  • Minimum Bachelor of Science degree required (Chemistry, Biology or related field).


 

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.

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