Director - Analytical Methods Development - Sangamo BioSciences - San Francisco

Job description
The Director Analytical Methods Development (AMD) will lead activities related to the development, qualification and validation of analytical methods for the characterization, release testing and stability testing of the Company’s products. Such products include recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and gene modified hematopoietic stem cells.


The successful candidate will be responsible for overseeing AMD activities at the Company’s designated Contract Manufacturing Organization’s (CMOs), as well as building and leading a team responsible for developing and, phase appropriately qualifying/validating, analytical methods for their onward technology transfer, either to CMOs, Contract Testing Organizations (CTOs), or to the Company’s in-house Quality Control (QC) department.



ESSENTIAL FUNCTIONS:

Lead activities related to the development, qualification/validation and implementation of analytical methods for the characterization, release testing and stability testing of the Company’s products, including:
Bacterial plasmid DNA ancillary products
Messenger RNA ancillary products
Recombinant AAV drug substance and drug products
Gene-modified T cell and hematopoietic stem cell drug products
Oversee AMD activities at CTOs, including the review and approval of development/qualification/technology transfer protocols, final reports, Standard Operating Procedures (SOPs) and forms
Drafting and review of SOPs, forms, test records and protocols to facilitate transfer of methods to CMOs/CTOs, or to in-house GMP manufacturing operations
Transfer of processes and training of staff at CMOs,/CTOs, or within the in-house QC department
Application of statistical tools to:
Design experiments/protocols for the development and validation of analytical methods
Set phase-appropriate release specifications
Assist in the preparation of CMC regulatory submissions

Desired Skills and Experience
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.

Candidate must possess:

A minimum BS and most likely an MS or Ph.D in Biological Sciences, Bioengineering or Chemistry
Minimum of 10 years of experience in the biotechnology or pharma industry with a primary focus on AMD for biologic products
Demonstrated track record of leadership and management of AMD groups
In-depth experience of assays methods and regulatory/pharmacopeia requirements for biologic products


OTHER REQUIREMENTS:

Experience of characterization and release testing of viral vector-based and cell-based products a plus
Experience with analytical techniques including FACS, High Content Analysis (HCA), ELISA, Capillary Electrophoresis, DNA sequencing and cell-based assays
Experience of managing CMO/CTO relationships and projects
Sound understanding and demonstrated application of statistical methods/tools
In-depth knowledge of US and European Pharmacopeia methods and requirements
In-depth knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements
Excellent interpersonal skills
Outstanding organizational skills
Excellent written and oral communication skills
Ability to operate in a fast-paced, multi-disciplinary industrial environment

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