Senior Scientist, Formulation Fill/Finish
Senior Scientist, Formulation Fill/Finish
Posted on :
13-06-2025
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1 Vacancy
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Job Description
Title: Senior Scientist Formulation & Fill/Finish
Manager: Vice President Technical Development
Department: Formulation & Fill/Finish
Location: Brisbane
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 life-limiting conditions by replacing todays symptom-focused 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 best-in-class viral vector and cell therapy products. The successful candidate will be responsible for Formulation and Drug Product process development of clinical candidates. Support the design and execution of process characterization/validation studies as well as lead technical process transfer to internal and external manufacturing sites in support of clinical development and commercialization of Sangamos internal and partnered programs. They will operate in a matrixed environment and collaborate successfully with colleagues within Technical Operations and cross-functionally with clinical external manufacturing supply chain and commercial groups to drive product and process excellence. This individual will manage supervise teams and support program deliverables.
Manager: Vice President Technical Development
Department: Formulation & Fill/Finish
Location: Brisbane
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 life-limiting conditions by replacing todays symptom-focused 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 best-in-class viral vector and cell therapy products. The successful candidate will be responsible for Formulation and Drug Product process development of clinical candidates. Support the design and execution of process characterization/validation studies as well as lead technical process transfer to internal and external manufacturing sites in support of clinical development and commercialization of Sangamos internal and partnered programs. They will operate in a matrixed environment and collaborate successfully with colleagues within Technical Operations and cross-functionally with clinical external manufacturing supply chain and commercial groups to drive product and process excellence. This individual will manage supervise teams and support program deliverables.
ESSENTIAL FUNCTIONS:
- Lead formulation and Drug Product deliverables to support pre-clinical clinical/pivotal studies leading to IND BLA/MAA and commercial launch
- Plan design and execute univariate/multivariate formulation and DP process characterization/validation studies and drive timely execution with quality oversight
- Perform analytical testing with chromatographic and biophysical methods (e.g. SEC-MALS DLS spectroscopy etc.) to support product and process characterization.
- Devise the DP process technology transfer qualification and validation strategy for clinical/commercial product site transfer
- Provide on-going fill-finish manufacturing support to Drug Product sites/CMOs: including technology transfers and impact assessments during quality investigations to ensure product and process consistency
- 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
- Author and review technical protocols and reports to document study findings in support of Investigational New Drug (IND) IND amendments BLA/MAA and other global regulatory filings.
- Lead and/or participate in CMC/project teams for functional representation as well as support teams objectives and project deliverables.
- Develop and implement novel biochemical and biophysical methods suitable for gene therapy molecular assessment and product characterization.
- Build mentor and supervise full-time employees contractors and consultants to deliver organizational goals
- Excellent communication 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 6years of product development experience in industry or BS/MS with 8 years of experience
- Experience with biologics formulation development Drug Product process design and manufacturing Fill/Finish is highly desirable
- Experience with AAV gene therapy process/formulation/analytical development is a plus
- Sound understanding of analytical methods for formulation characterization (e.g. qPCR/ddPCR UV-vis H/UPLC capillary electrophoresis and biophysical techniques (e.g. SEC-MALS DLS AUC Fluorescence particle analysis etc.)
- Experience in QbD methodologies and statistical analysis using JMP or Minitab.
- Good knowledge of HA guidance as well as cGMP and ICH requirements
- Self-starter solution oriented with collaborative mindset and strong executive presence with strategic and analytical abilities
OTHER QUALIFICATIONS:
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.
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.
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.
By signing below I acknowledge the requirements of my position as defined in this Job Description:
Signed:
Date:
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.
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.
By signing below I acknowledge the requirements of my position as defined in this Job Description:
Signed:
Date:
Required Experience:
Senior IC
Employment Type
Full Time
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