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Specialist/Senior Specialist, Quality Control Operations (CONTRACT)

Employer
Sangamo Therapeutics, Inc.
Location
Brisbane, CA
Start date
Sep 22, 2022

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Discipline
Manufacturing & Production, Operations, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

Manager: Associate Director, Quality Control Operations

Department: Technical Operations – Quality Control

Location:  Brisbane


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.

JOB SUMMARY:   

Sangamo is seeking a talented and highly motivated Specialist/Senior Specialist to join our QC Operations team. This individual will be tasked to contribute to the success of the QC Operations team, including sample management systems, and quality records within QC. Products to be supported include, recombinant viral vectors (AAV and lentivirus), ex-vivo gene-modified T cells, and gene editing mRNAs.

ESSENTIAL FUNCTIONS: 

  • Generate/revise documents such as SOPs, raw material specifications, batch records and/or work instructions
  • Review executed documents such as logbooks, engineering run protocols and batch records
  • Perform deviation and OOS investigations and generate investigation summaries
  • Initiate and drive change controls
  • Support validation activities such as URS revision/generation, IOPQ protocol generation/review/execution/approval and qualification summary report generation/review/approval
  • Work with QC senior management to implement and oversee a compliant, inspection ready QC sample management program. Specific duties:
    • Work with GMP-manufacturing personnel to ensure and document the timely and accurate receipt, storage, and distribution of all internally generated QC samples.
    • Work with QC-external operations to ensure and document the accurate and timely receipt, storage and distribution of test samples generated by our external manufacturing partners.
    • Work with each of the QC laboratory managers to coordinate the transfer and shipping (as necessary) of GMP test samples, reserve samples, and retain samples.
    • Work with the QC data management team to develop and maintain an electronic inventory system for QC sample storage (reserve and retain samples) with the ultimate objective of developing and integrating a sample management module into the QC LIMS product lot management system.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

The ideal candidate for this position will have demonstrable in-depth knowledge and understanding of QC data analyses associated with the testing of ATMP manufacturing intermediates and final drug products.

The successful candidate must:

  • Possess a BS degree in the Life Sciences (Molecular and Cellular Biology, Biochemistry, or a related field). Course work/formal training in statistics and/or biostatistics is a must. Course work in immunology, virology and cell biology is a plus.
  • Have 3+ years of quality control experience in a QC analytical laboratory setting. Experience testing ATMPs, Advanced Therapeutic Medicinal Products (Cell and Gene Therapy) is a plus.
  • Have an understanding of cell-based bioassays, nucleic acids testing, analytical chemistry (HPLC), and immunoassays with expertise in at least one of these areas.
  • Must have ability to work both independently and in a team-oriented environment with minimal supervision.

OTHER REQUIREMENTS:

  • The successful candidate will possess excellent oral communication skills.
  • The successful candidate will possess excellent scientific writing skills (a scientific publication record is a plus).
  • The successful candidate should possess strong interpersonal skills with the capability to establish collaborative working relationships across QC functions, and with members of the Product Development, Manufacturing, QA, and Regulatory teams.
  • The successful candidate will have the ability to operate in a fast-paced, multi-disciplinary industrial environment.

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 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 & booster, you will have an opportunity to request a reasonable accommodation consistent with applicable laws. 

Note to External Recruiters: We do not accept unsolicited resumes from any source other than from the candidates themselves.

Company

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. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform 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.

Stock Symbol: SGMO

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Find Us
Website
Phone
(510) 970-6000
Location
7000 Marina Blvd
Brisbane
CA
94005
United States
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