Partner Therapeutics (PTx) is a commercial biotech committed to improving the lives of patients with cancer and other serious diseases. In today’s challenging healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. For more information, visit www.partnertx.com.
The Process Science group at Northpointe is a group of Subject Matter Experts (SME) who specialize in the development of scalable processes for manufacturing, Raw Materials tests and Analytics for release. Work is performed in laboratory models and the processes or methods are transferred to manufacturing or Quality Control respectively.
POSITION OVERVIEW/KEY RESPONSIBILITIES
This position is specifically responsible for providing expertise for the development and maintenance of bioassays. This role will be the company SME on bioassays and provide Scientific oversight around development, optimization, re-validation, and transfer of the bioassay. Additionally this role will make technical decisions regarding testing.
- Develops and authors complex documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics.
- Solves assay/process problems through interdepartmental project teams as well as external groups.
- Identifies potential problems and proactively suggests technical solutions based upon analytical expertise, knowledge of product/process and available resources.
- Independently employs in-depth technical knowledge to define and manage laboratory studies or investigations of quality control procedures.
- Coordinates completion of specific project tasks with other departments.
- Oversees and directs the training and work of lower level analysts and scientists in technical projects.
- May participate in teams to ensure specifications are technically appropriate based on mfg. process/method capability; evaluate trends in test results and propose new specifications as appropriate.
- May manage contract lab method qualifications and investigations.
- May initiate and/or evaluate change controls/deviations related to test methods and/or specifications.
- May function in a project leadership role.
- Assists with preparation of regulatory submissions.
- Participates in compliance audits, as appropriate.
*Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
- Bachelor’s degree and 15 or more years’ experience in Science or related field.
- Master’s and 10 or more years’ experience.
- D. and 5+ years’ experience.
Thorough knowledge of and application of cGMP, ICH guidelines, QA/QC and regulatory compliance.
Partner Therapeutics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. PTxoffers a very competitive compensation package with generous PTO.
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