WuXi AppTec • Philadelphia, PA 19133
Job #2710420535
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
participate in early discussions with clients, and offer constructive opinions and
guidance on working order signing from analytical perspective.
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.
including coordinating internal and external resources, controlling key milestones,
overall progress, project scope, and indicators. Demonstrate proficiency in project
risk management.
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.
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).
instructions on new assignments.
Qualifications
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
Knowledge / Skills / Abilities:
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.
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
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