Manager/ Senior Manager Analytical Chemistry
- Rain Oncology
- Newark, CA
- Start date
- Mar 14, 2023
- Information Technology, Business/Data Analytics, Science/R&D, Bioanalytical Services, Chemistry
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay
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
Rain BRINGS LIFE
The beauty and complexity of life is near limitless, with the world around us based on the cyclicality of the seasons and marking a shift in the progression of life. When the rains come, they bring sustenance to the life all around us, from which there is renewal and replenishment. Water and the rain help reinvigorate life and strengthen us for the path forward.
Rain Oncology was named to symbolize the renewal, sustenance and replenishment that reinvigorates life afforded by the rains. In the same way, we hope to provide a renewal and reinvigoration for patients debilitated by cancer. Rain Oncology hopes to leverage industry-leading insight into the mechanisms triggering cancer to find precision therapeutic strategies that may offer patients an improved chance of getting their lives back.
Rain Oncology was founded in 2017 as a precision oncology company leveraging a deep scientific knowledge of drug mechanism and designing clinical trials with the most appropriate patient population most likely to benefit from treatment. Rain is focused on a few critical objectives: (1) strive to greatly enhance probabilities of therapeutic success for patients by focusing on genetic biomarkers that may predict optimal therapeutic strategies, and (2) pursue biomarker-based trial designs of limited size that enable rapid decision-making and redirecting of strategy when needed, minimizing expense and preserving capital resources.
Our team is the heart and soul of Rain Oncology. Not only is a dynamic, energetic, entrepreneurial team essential to drug development success at Rain, it's also paramount to the type of culture where people feel rewarded every day.
Rain Oncology is looking for team members that don't want to work in a conventional corporate environment. We are looking for professionals who believe, at their core, that a small company that empowers its people can move much more quickly and effectively than large organizations with significantly more financial firepower. Rain Oncology is looking for experts who want more control in galvanizing 21st-century science for patients.
Stock Symbol: RAIN
8000 Jarvis Ave Suite 204
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