Overview

Overall responsibility for the analytical strategy, execution, tracking, and preparation of

regulatory filing documents for the analytical part of cell and gene therapy product

projects, ensuring timely and high-quality delivery.

Responsibilities

• Provide analytical CMC-related support for new working order signing at BD,

participate in early discussions with clients, and offer constructive opinions and

guidance on working order signing from analytical perspective.

• Develop phase-appropriate analytical strategies, including characterization of CGT

products, analytical method development or transfer, qualification/validation,

specification development, quality control testing in a cGMP environment, stability

studies, quality comparability, reference standard etc. Ensure that project

requirements meet the regulatory requirement of the target filing country.

• Possess good project management skills for the analytical aspects of the project,

including coordinating internal and external resources, controlling key milestones,

overall progress, project scope, and indicators. Demonstrate proficiency in project

risk management.

• Author, review and/or approve relevant technical documents, including but not

limited to product specifications, quality comparability study protocols and reports,

stability protocols and reports, analytical method development and

validation/verification reports, project reference standard qualification protocols

and reports etc.

• Author and support the analytical CMC section for IND/IND amendment/BLA

application documents for the target country, ensuring the integrity, truth, and

accuracy of the filing documents. Organize the responses to related information

request/queries as required by clients or Health Authorities.

• Collaborate with PM, AD, QC manufacturing, PD, QA, RA, and other crossfunctional teams to drive the project process and meet client expectations.

• Establish and improve relevant department systems and SOPs

• Train in leadership and supervisory activities and courses.

• Ability to accomplish the described duties through the use of appropriate

computer equipment and software (Microsoft Word, Excel, Outlook, and

Access).

• Normally receives minimal instructions on routine work and detailed

instructions on new assignments.

• Contributes to the overall operations and to the achievement of departmental goals

Qualifications

• 8 yrs experience with a Bachelors’ degree, 6 yrs experience with a Masters’ degree

and 3 yrs experience with a PHD; Preference given to candidates with

pharmaceutical industry experience.

• Cell and Gene Therapy and/or biopharmaceutical industry preferred

• Masters, Bachelors degree in a pharmacy/biopharmaceutical and/or other Science

related field or equivalent experience

• Preferred ASQ certification

Knowledge / Skills / Abilities:

• In-depth knowledge of a wide range of analytical methods, including molecular

biology, cell biology, flow cytometer, immunology, and HPLC.

• Experience in method transfer, validation, and troubleshooting is preferred.

• Familiar with USP, EP, JP, ChP, and ICH guidelines and regulations.

• Experience in authoring IND/BLA submission documents and relevant technical

documents is highly preferred.

• Thorough working knowledge of Regulatory Compliance, Quality System

Management and Quality Assurance principles and practices.

• Knowledge of FDA cGMP requirements, FDA PTC guidelines required.

• Knowledge of EU cGMPs highly desirable.

• Ability to write and revise documents. Ability to use judgment in situations for which

there are no precedents.

• Experience in GMP.

• Ability to work under limited supervision and to handle problems of a difficult

nature.

• Proficient in Oral & Written communication skills

• Need to be able to read, write and understand English

• Proficient in Microsoft (Excel, Word, Outlook)

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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Job Locations US-PA-Philadelphia

Job ID 2024-12860