Manager, CMC Technical Writing

Foster City, California, United States · CMC

Description

The Manager/Senior Manager CMC Technical Writing will provide expert support to the CMC Management Team for the initial writing of and/or subsequent maintenance of CMC documentation related to the development, and commercialization of Orchard Therapeutics innovative gene-modified cell-based therapeutic products. Such activities will include the initial writing, subsequent maintenance and as required updating/revision of:

Requirements

Responsibilities

1. Writing and subsequent maintenance of the accuracy of CMC information in IND, IMPD, BLA and MAA filings

2. Writing and subsequent maintenance of the accuracy of reports related to the development, characterization and validation of manufacturing processes and analytical methods

3. Co-ordinate document assignment, filing and maintenance with QA Document Control

4. Co-ordination with Regulatory Affairs to integrate new CMC information and/or update existing CMC information into regulatory filings

5. Must interact with internal groups, CMOs, collaborators, and partners to ensure required CMC information is accessible and organized

6. Other activities as may be assigned

Job Requirements

The ideal candidate for this position will have a proven track record of personally writing CMC documentation for fast-paced programs developing innovative biotechnology products.

Candidate must possess:

A minimum, BS or equivalent, in bioprocessing, medical technology, chemical engineering, or biological sciences

Minimum of eight years of experience of innovative product development in the biotechnology or pharma industry with a primary focus on personally writing CMC information for:

Excellent written communication skills

Proven track record of effective interaction with CMO’s/partners

Experience of manufacturing process and/or assay development, characterization and validation requirements

In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements

Other Requirements

Proven personnel and project management skills

Outstanding organizational skills

Excellent oral communication skills

Ability to operate in a fast-paced, multi-disciplinary industrial environment

Some travel (domestic and international) will be required

Benefits

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.


RECRUITERS

All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.

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