Andover, MA, United States
Healthcare, Project Management, Executive, Manager, Chemistry
SUMMARY OF POSITION:
The Director, Ophthalmic Product Development and Manufacturing is responsible for the early stage development of Sponsor ophthalmic products (formulation and analytical method development) ultimately leading to manufacturing of products for non-clinical and clinical studies. This role provides program direction, quality oversight of contract laboratories and manufacturing sites, management of timelines and coordination/writing of the CMC sections of both pre-IND and IND packages..
Provides program management and quality oversight for the development of Sponsor ophthalmic products.
Performs on-site quality oversight at contract laboratories and manufacturing sites
Selects contract laboratories and manufacturing sites for development projects.
Provides support and backup to the department head.
Effectively builds project teams as necessary
Oversees the creation of detailed project plans to ensure clarity of deliverables and timing
Provides feedback to management of project progress/scope changes/new business opportunities
Cultivates effective communication, cooperation and trust with clients. Coordinates routine update meetings on project progress with Sponsor
Coordinates, writes and reviews CMC sections of all regulatory submissions
Interfaces with FDA division personnel to present pre-IND and IND packages
Reviews all analytical data to be submitted as part of a regulatory submission.
REQUIRED SKILLS AND ATTRIBUTES:
Bachelor’s degree in Chemistry or Chemical Engineering; MS preferred
Solid skills in analytical method development
Minimum of 10 years working in highly technical scientific field
Minimum of 5 years of Project Management experience
Previous experience solving formulation/analytical/ manufacturing issues in ophthalmic biotech/pharma organizations required
Prior task management experience with proven record for effective cost and schedule control of multi-disciplinary technology-based tasks in the pharmaceutical or biotech industry
Previous manufacturing (aseptic)/quality operations support experience required
FDA exposure and/or interface required
Previous experience creating the CMC section of Pre-IND and IND packaging
Proven ability to effective lead and manage individuals and teams
Ability to develop and maintain relationships at all levels within Ora and with Ora’s Sponsors
Excellent communication skills, both oral and written
Ability to travel approximately 25% of the time
Website : http://www.oraclinical.com/