Group Leader, Formulation Process Development - Foster City, CA | Biospace
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Group Leader, Formulation Process Development

SutroVax Inc

Location:
Foster City, CA
Posted Date:
2/2/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Analytical Chemistry, Formulation, Process Development, Protein Purification,

Job Description

Company Profile:
SutroVax is an independent vaccine platform and development company whose mission is to deliver best-in-class conjugate vaccines and novel complex antigen-based vaccines to prevent deadly infectious diseases. The company is leveraging its exclusive license to Sutro Biopharma’s Xpress CF TM platform to perform cell-free (CF) protein synthesis and site-specific conjugation for the field of vaccines.

Professional Responsibilities:
SutroVax is looking for an energetic and talented individual to lead the Formulation Development function within Process Development. The successful candidate will be a subject matter expert in Formulation Development. SutroVax is focused on the development of protein conjugate vaccines. Hence, the successful candidate will ideally not only have experience formulating proteins, but also have experience formulating complex mixtures such as adjuvanted polysaccharide-carrier proteins. The successful candidate will partner with the leader of the Analytical function in the PD group, providing rigorous scientific leadership for the Process Development function (which reports into the Vice President of Process Development and Manufacturing). The successful candidate will be conversant with GMP manufacturing requirements, and be familiar with current regulatory guidance documents. Experience directing activities performed at contract manufacturing organizations (CMO) is highly desired. The successful candidate will interface closely with the Research group, write detailed technical reports, make presentations to outside collaborators and senior management, and author internal and external publications.

Requirements

Skills, knowledge, and experience:
•   PhD in Pharmaceutical Sciences, Biochemistry, Chemical / Biochemical Engineering, or a related discipline, with 5+ years of industry experience; MS or BS with 10+ years of industry experience
•   Proven leadership skills; multiple years of experience managing one or more direct reports
•   Formulation development subject matter expert, with broad proficiency in related skills such as purification or analytical development
•   Expertise in the development and manufacture of parenteral formulations (e.g., proteins, peptides, ADCs, viral particles, vaccines); experience formulating adjuvanted vaccines is a plus
•   Solid understanding of GMPs; ideally, experience working within QC environment
•   Working knowledge of ICH guidance documents specifying stability study best practices; experience performing (or overseeing the performance of) formal stability protocols
•   Experience working with CMOs highly desired; ability to effectively transfer formulation processes to CMO, and to oversee development and manufacturing activities performed at CMO; ability to travel to CMO (some travel required) to perform person-in-plant oversight activities
•   Solid understanding of the principals of DoE (Design of Experiments); practical experience with DoE software; proficient in the design and interpretation of statistically-modelled experiments
•   Broad understanding of drug development, with experience writing IND section(s)
•   Proficiency running gel- and column-based analytical methods a plus; such methods may include CE-SDS, icIEF, SEC-HPLC, HIC-HPLC, IEX-HPLC, RP-HPLC
•   Demonstrated ability to work collaboratively in a cross-functional team environment on multiple projects
•   Strong interpersonal skills, with excellent written and verbal communication skills

Reports to: Vice President, Process Development & Manufacturing

Location: Foster City, CA

Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.