Technical Project Manager

Company: Otsuka Pharmaceutical
Location: Princeton
Posted on: June 25, 2022

Job Description:

Job Description- This role provides analytical and technical support, manages activities at contract laboratories, including analytical method validation/qualification, ID testing, release testing, stability testing, investigational testing.- There is responsibility to develop, manage and monitor stability programs for commercial products, clinical trial materials, and developmental projects.- The candidate will also review test results/raw data to ensure that results meet specifications, test procedures were followed, and laboratory work is documented appropriately.--- Effectively manages contract laboratories with regards to quantitative and qualitative analytical testing of developmental, clinical, and commercial pharmaceutical and related products (including raw materials, in-process materials, and finished products) and reporting of results.- Reviews, interprets, and evaluates analytical data, including raw data, of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance within Otsuka and GxP requirements.- Monitors stability studies of developmental, clinical, and commercial pharmaceutical and related products tested by contract laboratories.- Reviews, enters, and maintains stability data for developmental, clinical, and commercial pharmaceutical and related products.- Transfers analytical methods between Otsuka Japan, contract laboratories in the US, and other international affiliates.- Prepares and maintains QC documentation, including protocols, reports, and test methods.- Audits external analytical laboratories as subject matter expert.- Procures reference materials for contract analytical laboratories.- Writes/reviews CMC section of PMA, NDA and IND assuring completeness and accuracy- Maintains and updates department documents required for regulatory compliance--- Assures testing requirements adherence to latest regulatory standards--- Serve as a scientific liaison on selected development projects for quality control matters.- Lead technical investigations- Lead the selection of external labs- Manage vendor contracts- 10% travel requiredQualifications:Required- Bachelors degree in chemistry or related science + 10 years' work experience in a GXP environment focused on analytical laboratory testing of pharmaceuticals and related materials- Experience with MS Office, especially MS Excel- Experience with oral solid dosage forms - tablets or capsules,--- Develop technical solutions to complex problems and apply expertise to find solutions- Experience in data review- Experience in LIMS user role- Must exhibit excellent oral and written communication skills and may be required to revise or create SOP's- Good planning and coordination skills resulting in meeting tight timelines as required--- Sound judgment, decision-making skills, negotiation skills, and good organizationalCompetencies- Must have excellent interpersonal skills and must have demonstrated ability to work effectively in a multifunctional team environment (within Otsuka and externally with vendors) and is recognized as the subject matter expert for their QC projects.- Possess effective project management skills that will require working with different functional groups at the same time.- Develop project plans and corresponding project management tools to support the execution of all projects- Develop and manage project budgets appropriately- Develop & maintain good working/business relationships with internal & external customers#LI-Remote

Keywords: Otsuka Pharmaceutical, Trenton , Technical Project Manager, IT / Software / Systems , Princeton, New Jersey