| Job Description | Manage the upstream process development activities and support CMC strategies across the product development cycle, including strain development, fermentation process development, process scale up, tech transfer and analytical implementation. Ensure that products manufactured to support pre-clinical and clinical studies are in compliance with the requisite regulations and guidelines.
Position Duties and Responsibilities
?Leads and direct fermentation process development team efforts in the development and optimization of strain/fermentation development processes.
?Deep understanding of strain/expression optimization and fermentation concepts, practices, and procedures (including process scale-up and tech transfer).
?Ability to identify and implement the necessary analytical tools to ensure the success process development efforts from research through to clinical and/or /commercialization.
?Responsible for thorough record keeping by staff, such that accurate records, timely data-basing and ease-of-access to results is maintained.
?Prepare protocols for- and reports of- completed projects for presentation to company personnel, external partnering organization and/or publication.
?Provide oversight and support technical transfer of upstream processes to partnering entities. Foster and maintain strong relationships with contract manufacturers, testing labs and other partnering entities including construct development and cell banking entities.
?Relies on experience and judgment to plan and accomplish tasks efficiently.
?Support successful preparation of CMC sections for regulatory submissions.
?Be able to prepare peer-reviewed publications.
?Receive and implement strategic directives from Senior Management.
Key Requirements/Degree Requirements
?BS/MS from a qualified university in Life Science/Chemistry/Engineering or related fields and 5-10 years of related work experience including supervisory roles, or
?PhD degree from a qualified university in Life Science/Chemistry/Engineering or related fields and 3-5 years of related work experience including supervisory roles
Special Skills and Qualifications
?Ability to communicate effectively, both verbally and written.
?Must be highly organized, analytical, accurate and detail oriented.
?Must have hands-on familiarity with standard strain development/optimization techniques as well as bench-scale fermentation equipment and associated analytical equipment.
?Must be able to read and interpret technical, trade documents, and journals.
?Must be able to analyze and prioritize assignments; also must judge the amount of time spent for an expected outcome, and manage resources according to the importance of a project and the type of information needed.
?Must be able to lead a team, manage personnel and multiple projects. |
| | Company | | Amunix Operating, Inc | Job Code | | State or Province | | California | | |
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