Temporary Scientist, Formulation Fill/Finish
Temporary Scientist, Formulation Fill/Finish
Posted on :
17-05-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Position:Temporary Scientist Formulation Fill/Finish
Manager: Vice President Technical Development
Department: Formulation & Fill/Finish Technical Operations
Location: Brisbane CA
Sangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases by using our wholly owned highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At Sangamo we are dedicated to building a robust sustainable genomic medicine pipeline that addresses lifelimiting conditions by replacing todays symptomfocused treatments with tomorrows genomic cures. 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. Lets build a better future together.
JOB SUMMARY:
Sangamo Therapeutics is seeking a highly motivated individual with drug product formulation and process development experience to contribute to the development of bestinclass viral vector and cell therapy products. The successful candidate will be responsible for the formulation and DP process development of clinical candidates design and execute process characterization/validation studies lead technical process transfer to internal and external manufacturing sites in support of clinical development and commercialization of Sangamos internal and partnered programs. The scientist will be responsible for authoring and reviewing technical reports and sections for regulatory submissions. The scientist will operate in a matrixed environment and collaborate successfully with colleagues within Technical Operations and crossfunctionally with clinical external manufacturing supply chain and commercial groups to drive product and process excellence. This individual will work independently leading projects and selfmanaging work packages with appropriate communication and escalation. This is a temporary assignment which will be onsite in our Brisbane CA facility. We are only considering candidates local to the San Francisco Bay Area.
ESSENTIAL FUNCTIONS:
Manager: Vice President Technical Development
Department: Formulation & Fill/Finish Technical Operations
Location: Brisbane CA
Sangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases by using our wholly owned highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At Sangamo we are dedicated to building a robust sustainable genomic medicine pipeline that addresses lifelimiting conditions by replacing todays symptomfocused treatments with tomorrows genomic cures. 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. Lets build a better future together.
JOB SUMMARY:
Sangamo Therapeutics is seeking a highly motivated individual with drug product formulation and process development experience to contribute to the development of bestinclass viral vector and cell therapy products. The successful candidate will be responsible for the formulation and DP process development of clinical candidates design and execute process characterization/validation studies lead technical process transfer to internal and external manufacturing sites in support of clinical development and commercialization of Sangamos internal and partnered programs. The scientist will be responsible for authoring and reviewing technical reports and sections for regulatory submissions. The scientist will operate in a matrixed environment and collaborate successfully with colleagues within Technical Operations and crossfunctionally with clinical external manufacturing supply chain and commercial groups to drive product and process excellence. This individual will work independently leading projects and selfmanaging work packages with appropriate communication and escalation. This is a temporary assignment which will be onsite in our Brisbane CA facility. We are only considering candidates local to the San Francisco Bay Area.
ESSENTIAL FUNCTIONS:
- Lead and/or participate in development activities to support clinical (Phase IIII) formulation and DP process development BLA licensure and commercial launch
- Lead and/or participate in CMC/project teams for functional representation as well as support teams objectives and project deliverables.
- Plan design and execute univariate/multivariate studies to develop robust and manufacturable formulations to support Tox phase I/III formulation and DP process development.
- Perform analytical testing with chromatographic and biophysical methods (e.g. SECMALS DLS spectroscopy etc.) to support product and process characterization.
- Process data compile results report and communicate study findings at functional and CMC team level.
- Author and review technical protocols and reports to document study findings in support of Investigational New Drug (IND) BLA as well as global marketing application submissions.
- Partner with internal/external manufacturing and quality for process improvement transfers compilation and review of batch records master production records and technical support to resolve investigations deviations corrective/preventative actions.
- Excellent communication and interpersonal skills and proven ability to work effectively in a matrix organization to meet team objectives
EDUCATION EXPERIENCE AND SKILLS REQUIREMENTS:
- Ph.D. in biochemistry pharmaceutical sciences biochemical engineering or related discipline and of 6 years of product development experience in industry or BS/MS with 8 years of experience.
- Experience with biologics formulation development DP process design and manufacturing Fill/Finish is highly desirable.
- Sound understanding of analytical methods (qPCR/ddPCR UVVis H/UPLC capillary electrophoresis and biophysical techniques (e.g. DLS CD FTIR DSC AUC Fluorescence particle analysis etc.) for formulation characterization.
- Experience in QbD methodologies and statistical analysis using JMP or Minitab.
- Good knowledge of HA guidance as well as cGMP and ICH requirements.
- AAV gene therapy Cell Therapy & Gene Editing experience is desirable.
- Team player with good interpersonal and organizational skills.
- Selfstarter solution oriented with collaborative mindset and strong executive presence with strategic and analytical mindset
We encourage you to apply even if you dont meet all the qualifications. We believe in the value of diverse perspectives and backgrounds and we welcome candidates who are eager to learn and contribute to our mission.
Sangamo is an equal opportunity employer
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 individuals 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.
Pay Range
The anticipated salary range is for candidates who will work in our San Francisco Bay Area work locations. 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 We will reach out to you directly if there is a business need for your services.
#LIAB1
Employment Type
Temp
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
