- 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 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 organizational
- 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
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.
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Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
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To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
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