Director, Analytical and Formulation Development - La Jolla, CA | Biospace
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Director, Analytical and Formulation Development

Ambrx, Inc.

Location:
La Jolla, CA
Posted Date:
9/11/2017
Position Type:
Full time
Job Code:
09-17BR
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Development, Director, Formulation,

Job Description


About Ambrx:

Ambrx, Inc. is a biopharmaceutical company with a mission to deliver breakthrough protein therapeutics. Ambrx is based on a fundamental advance in protein biosynthesis that enables the company to genetically engineer proteins with new amino acid building blocks beyond the common twenty, enabling the biosynthesis of proteins with new physical, chemical and pharmacological properties. At Ambrx, we are dedicated to assembling and developing an exceptional team and a breakthrough technology to create the next generation of protein-based medicines.

Job Description:

We are seeking a senior analytical expert to lead our Analytical and Formulation Development group at Ambrx. As a senior member of this function, this individual should be able to maintain high standards of technical and quality excellence and will be involved in managing scientists and associates on a daily basis.

The successful candidate will lead the group developing analytical methods/assays ensuring that the projects are progressing as planned, process and products meet quality and regulatory requirements. This individual will also play a critical role in research, research transitioning to development and product development stages. This individual should have extensive experience in protein and protein conjugates testing and characterization, significant experience with antibody and antibody conjugates is highly preferred.  

Requirements


Job Requirements:

•   Ph.D. in Analytical Chemistry or related field with 10+ yrs of relevant industrial experience in analytical development and characterization for proteins.
•   Demonstrated leadership in staff and project management is required.
•   Have both broad and in-depth knowledge as well as hands-on experience in modern analytical chemistry techniques (mass spectrometry, HPLC assays, CE, ELISA, biophysical assays etc.).
•   Proven record in developing and applying new technologies for complex protein molecules (including E. coli and CHO derived proteins/antibodies) and conjugates for both research and development purposes, excellent troubleshooting skills are required.
•   Extensive experience with assay development, qualification/validation and tech transfer to CMO to support clinical manufacturing is required. Be responsible for writing and reviewing development reports, SOPs, qualification reports, analytical protocols etc. Prior experience in GMP-compliance and Quality/Regulatory Assurance is a plus.
•   Coordinate projects and resources in support of new and ongoing projects, from research to clinical stages.
•   Demonstrated ability to set clear and measurable goals for function and prioritize tasks and resources to achieve superior work quality and efficiency.
•   Excellent oral and written communication skills, be able to communicate effectively to senior management, corporate functions and collaborators.

To be considered for this position, please submit your resume/CV referencing the specific position of interest and position code. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Ambrx offers competitive compensation & benefits.  EOE