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

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.
Ability to manage independently the complicated key account projects, and
possess strong 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.
Demonstrate comprehensive control at the project execution level, including
identifying risks in the analytical development and quality control (ADQC) aspect
of the project: identify analytical technical challenges and takes the lead in crossfunctional teams to address these challenges, aligns technical solutions within the
team and make decisions to resolve problems.
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.

Presents technical seminars and provides training on areas of analytical CMC of
CGT
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.

12 years of experience with a Bachelors degree, 8 years of experience with a
Masters degree, and 5 years of experience with a PhD. Preference given to
candidates with pharmaceutical industry experience.
Cell and Gene Therapy and/or biopharmaceutical industry preferred
Bachelors, Masters or above 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.
Excellent written and oral communication skills in English . Ability to use judgment
in situations for which there are no precedents.
Ability to work under limited supervision and to handle problems of a difficult
nature.
Ability to identify resolutions to complex problem requiring multiple actions
Ability to appropriately evaluate risk and select optimal/efficient resolutions
Possess strong self-learning abilities and the capability to promptly study
and grasp domestic and international pharmaceutical registration
regulations and technical guidelines.

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.