Wang, Mandy Email & Phone Number

Cambridge, Ma, Us

Ingelheim Am Rhein, Rhineland-Palatinate, De

- Responsible for providing quality overnight to commercial production of bulk drug substance - Manage client communication and seek alignment in quality decisions to meet production and batch release plans - Perform review, approval and tracking of cGMP processes and procedures, including deviations, CAPAs, and change control

Ingelheim Am Rhein, Rhineland-Palatinate, De

- Support contract manufacturing business from clinical to commercial production and serve as process validation lead as CMO site- Manage timeline of PPQ prerequisites and deliverables from internal and client teams to ensure project timeline is met- Lead cross-functional team to develop process validation strategy. Create control strategy documents, validation master plans, protocols and reports that meet regulatory requirements- Manage contractors and FTEs to ensure on time completion of PPQ and Pre-PPQ deliverables. Provide technical support and guidance in protocol creation, execution coordination and data interpretation - Coordinates with global teams to develop validation guideline documents as well as site specific procedures - Provide QA oversight for equipment qualification and CSV to support GMP manufacturing

Sant Cugat Del Vallès, Barcelona, Es

- Lead the development and execution of process performance qualification protocols- Provide expert guidance for the resolution of technical issues arising during the execution of performance qualification activities- Write, review and approve process validation plans and Lifecycle Stage 2 process qualification protocols/reports- Review and approve Lifecycle Stage 1 process design documents and process characterization study protocols/reports- Ensure the maintenance of a qualification document listing for all process validations- Participate in Lifecycle Stage 3 continued process verification meetings as a technical subject matter expert

Basel, Baselstadt, Ch

- Develop and author technical documents and characterization study protocols/reports to support Lifecycle Process Validation of protein antigen products- Prepare Lifecycle Stage 1 documents including PRMP, PRMR and criticality assessment- Provide technical expertise and review for other lifecycle related activities, such as FMEA and validation element assessment- Coordinate and support characterization and validation study execution in the laboratory and Manufacturing. Generate ISRs / GIRs

Menlo Park, Ca, Us

- Develop and improve fermentation and purification processes for recombinant proteins produced in E Coli - Create QC analytical assays and product specifications- Establish receiving and inspection procedure and testing protocols for raw materials- Complete manufacturing and in-process testings for protein products used for DNA sequencing technology

Brea, California, Us

- Provide technical support for GMP manufacturing of immunoassay reagents- Lead cross-functional teams to resolve nonconforming issues and conduct deviation investigation - Develop strategies and execute process validation, raw material qualification, equipment validation and analytical test method validation- Create design change plans to implement raw material and process changes in manufacturing - Good documentation and writing skills in validation/verification protocols and reports, SOPs and other technical documents

Minnneapolis, Mn, Us

Phd, Cellular And Molecular Biology

Bs, Chemistry