Manager/Senior Manager, Analytical Chemistry
Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Oncology is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted therapies for cancer patients struggling with limited treatment options. Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.
The Manager/Senior Manager, Analytical Chemistry position will assume a hands-on role with internal and external CMC activities for Rain Oncologys' small molecule programs. Responsibilities will include providing support for drug substance and drug product stability studies including protocol/report review, data package review, and data trending. In addition, entering stability data in statistical software, JMP or other is required. Additional responsibilities will include but not limited to data review for drug substance and drug product lot release as well as other analytical chemistry activities related to impurity standards qualifications, Phase 3 method validations, method transfers etc.
- Experience with the implementation and management of stability studies at CMO’s/CTO’s for small molecule drug substances and drug products in clinical phases.
- Ability to track and trend stability data using statistical software, JMP and author stability reports.
- Experience with providing technical assistance and support to CMO’s/CTO’s for contracted activities such as stability studies, method development, method validations, and method transfers, lab investigations, and deviations.
- Experience with review and approval of cGMP documents from CMO’s/CTO’s including analytical study protocols, reports, lab investigations, and deviations.
- Collaborate with QA, CMC team, and CMO’s/CTO’s to achieve timely generation and approval of data packages, protocols, reports, and other documents.
Preferred Education and Experience:
- BS in chemistry, pharmaceutical sciences, or related discipline required.
- Approximately 5 years of experience in the small molecule pharmaceutical industry with method development, method validation, stability program management and data review.
- Excellent knowledge in regulatory, ICH and cGMP requirements
- Excellent organizational skills, including flexibility and adaptability to rapidly changing priorities.
- Strong critical, strategic, and analytical thinking skills.
- Successful interpersonal and communication skills resulting in the ability to organize complex scientific topics and present them to a cross-functional team.
Rain Oncology Inc. is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.
The pay range that the Company reasonably expects to pay for this position is $180,000 - $208,000; the pay ultimately offered may vary based on objective considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of financial, health and wellness benefits, dependent on the position offered