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Job Details

Director Ophthalmic Product Development and Manufacturing

Company name
Ora, Inc.

Location
Andover, MA, United States

Employment Type
Full-Time

Industry
Healthcare, Project Management, Executive, Manager, Chemistry

Posted on
Dec 03,2019

Valid Through
Mar 17,2020

Apply for this job






Profile

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..

PRIMARY RESPONSIBILITIES:

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

Company info

Ora, Inc.
Website : http://www.oraclinical.com/

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