Scientist II, Analytical Development
Sr. Manager, Analytical Development
Analytical Development – Technical Operations
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo
genome editing, and in vivo
genome regulation. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today's medicines can only treat symptoms. At Sangamo, we are passionate about transforming lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo
genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let's build a better future together.
Sangamo Therapeutics is seeking an Analytical Development Scientist II to help perform laboratory-based activities to design, develop and qualify analytical methods for the characterization, release testing and stability testing of the Sangamo's recombinant Adeno-associated Virus (rAAV) Gene and Cell Therapy products. The successful candidate will be responsible for developing analytical tools for method development and testing of in-process and final drug product of gene & cell therapy programs. The successful candidate will also be responsible for method development, assay optimization, training, and tech transfer to internal testing group. Additional duties will include representing AD function on cross-functional project teams and management of tech/methods transfer to in-house QC department as well as external contract manufacturing organization (CMO) and contract testing laboratories (CTLs) and subsequent method qualification and/or validation.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Design and execute laboratory-based analytical assay development, maintain development notebook records, draft and review SOPs, development reports, test records and protocols to facilitate transferring methods and training staff of the QC department or CTOs.
- Develop characterization and GMP release methods HPLC, SEC-MALS, DLS, CE-SDS, ELISA, qPCR, and other assays, set assay acceptance criteria and product specifications by applying appropriate statistical tools and comply with regulatory guidelines.
- Serve as technical subject matter expert for troubleshooting issues analytical methods.
- Develop the analytical characterization panel for testing of non-GMP and GMP products.
- Participate in preparation of reference standards, assay development plans, writing qualification and validation plans
- Assist in the preparation of CMC regulatory submissions.
- Other activities as assigned.
- Ph.D. in Chemistry, Biology, Biological Sciences, or biochemistry
- 2-5 years of experience in the biotechnology or pharma industry with focus on development of physico-chemical analytical techniques such as HPLC, SEC-MALS, CE-SDS, ELISA etc. for analysis of biologic drug products.
- The ideal candidate for this position will have demonstrated in-depth experience of the development, qualification, validation, and implementation of analytical methods for the characterization, release testing and stability testing of biologic products in an industry setting.
- Up-to-date knowledge on physico-chemical and biophysical analytical techniques for large biomolecules is a must.
- Drug development and analytical method development experience in AAV gene therapy field is strongly desired.
- Experience in developing assays for AAV-based gene therapy products, including qPCR, ddPCR, cell-based assays etc. is a plus.
- A strong commitment to experimental work is essential, as well as the ability to independently identify and solve complex problems to advance projects through the development process.
- Demonstrated expertise in the independent design and execution of analytical development projects.
- Excellent writing and editing skills are essential, including highly developed computer skills using Microsoft Word, Excel, PowerPoint, SoftMax Pro and Graph Pad Prism.
Sangamo is an equal opportunity employer
- Sound understanding and demonstrated application of statistical methods/tools.
- Excellent interpersonal skills, outstanding organizational skills
- Excellent written and oral communication skills
- Strong analytical, organizational and communication skills
Sangamo is committed to fostering belonging for all employees and embraces diversity, equity, and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual's race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.
Commitment to Safety
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
The anticipated salary range is for candidates who will work in our Brisbane or Point Richmond, CA offices. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience with the job, type and length of experience within the industry, education, etc.. This salary range may not apply to remote positions that work in other states.
Note to External Recruiters
We do not accept unsolicited resumes from any source other than from the candidates themselves. If you wish to be considered for the presentation of candidates, please email email@example.com. We will reach out to you directly if there is a business need for your services.