15 Analytical CMC Senior Manager Jobs in Philadelphia, PA
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Analytical CMC Senior Manager
$111k-137k (estimate)
Full Time | Durable Manufacturing
5 Days Ago
WuXi AppTec is Hiring an Analytical CMC Senior Manager Near Philadelphia, PA
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
guidance on working order signing from analytical perspective.
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.
overall progress, project scope, and indicators. Demonstrate proficiency in project
risk management.
stability protocols and reports, analytical method development and
validation/verification reports, project reference standard qualification protocols
and reports etc.
accuracy of the filing documents. Organize the responses to related information
request/queries as required by clients or Health Authorities.
Access).
pharmaceutical industry experience.
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.
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,
guidance on working order signing from analytical perspective.
- Develop phase-appropriate analytical strategies, including characterization of CGT
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,
overall progress, project scope, and indicators. Demonstrate proficiency in project
risk management.
- Author, review and/or approve relevant technical documents, including but not
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
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
Access).
- Normally receives minimal instructions on routine work and detailed
- Contributes to the overall operations and to the achievement of departmental goals
- 8 yrs experience with a Bachelors’ degree, 6 yrs experience with a Masters’ degree
pharmaceutical industry experience.
- Cell and Gene Therapy and/or biopharmaceutical industry preferred
- Masters, Bachelors degree in a pharmacy/biopharmaceutical and/or other Science
- Preferred ASQ certification
- In-depth knowledge of a wide range of analytical methods, including molecular
- 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
- Thorough working knowledge of Regulatory Compliance, Quality System
- 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
- Experience in GMP.
- Ability to work under limited supervision and to handle problems of a difficult
- Proficient in Oral & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Durable Manufacturing
SALARY
$111k-137k (estimate)
POST DATE
06/26/2024
EXPIRATION DATE
07/24/2024
HEADQUARTERS
PHILADELPHIA, PA
SIZE
50 - 100
FOUNDED
2009
CEO
SYLVESTER WILLIAMS III
REVENUE
$5M - $10M
INDUSTRY
Durable Manufacturing
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