Manager, Nonclinical Operations

Location
Working from home
Posted
Apr 19, 2021
Required Education
Bachelors Degree
Position Type
Full time

Manager: Senior Manager, Nonclinical Operations
Department: Nonclinical Development
Location: Remote, CA


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 about 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. Sangamo is a company where individuals can flourish, grow, and develop their expertise.

We are seeking top talent to join our team. Let’s build a better future together.

JOB SUMMARY:

The candidate will provide operations expertise to non-clinical pharmacology, toxicology, and bioanalytical groups. The individual will manage/coordinate study-related activities for projects in all stages of drug development and reports to Senior Manager, Nonclinical Operations. Activities include comprehensive CRO oversight, protocol development, reviewing reports and study related communications for content and accuracy, participate on study teams, coordinate test article shipping, sample receiving and distribution, and archiving (documents and samples). This individual will work collaboratively with internal and external cross-functional teams, collaborators and consultants to design and efficiently execute nonclinical studies that support clinical development and regulatory submissions. Additionally, the successful candidate will have an extensive nonclinical operations background, a strong understanding of the preclinical CRO landscape, drug/biologics development experience as well as a strong understanding of Good Laboratory Practices (GLPs) that will provide broad-based support to align the nonclinical efforts with the company’s philosophy on drug development.

Applicants, please note this is not a clinical research position.  This role is part of the non-clinical development team.

Managerial responsibilities may include but are not limited to mentorship and supervision of nonclinical operations staff.


ESSENTIAL FUNCTIONS:

  • Manage GLP and non-GLP nonclinical pharmacology and toxicology studies.
  • Prepare and/or coordinate review of study protocols, study reports, including SEND data sets and other study documents to ensure accuracy and timely completion of nonclinical studies.
  • Monitor study progress to ensure that study activities are consistent with the protocol and with the needs of the project.
  • Supervise the trafficking of study samples, data, and study documents between Sangamo, Contract Research Organization (CRO), or other outside collaborator.
  • Maintain records to ensure accurate sample inventory and traceability.
  • Ensure GLP studies are conducted in compliance with current regulatory requirements.
  • Conduct and/or oversee external inspections and audits of CRO facilities  (minimal travel to be determined).
  • Adhere to good documentation practices; departmental procedures and safety requirements.
  • Represent the department by participating on project teams.


EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

  • Bachelor’s degree or higher in a scientific discipline or related field
  • 5+ years biotechnology, pharmaceutical, or CRO experience
  • Detail-oriented with strong computer, organizational, writing and verbal skills
  • Capable of working independently and as part of a team
  • Ability to work within an environment with quickly changing processes, priorities, and deadlines
  • Familiar with GLP regulations, SEND requirements, and LIMS data systems

Sangamo is an equal opportunity employer

The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.

 



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