Key Responsibilities
Develop and optimize upstream and downstream processes to generate lead and Development Candidate TCR bispecific and to enable seamless technology transfer to contract manufacturing organizations.
Provide data packages, expertise, and guidance to TCR bispecific candidate nomination decision.
Transfer analytical methods to external CROs/CDMOs and provide additional training, troubleshooting, or technical support, as necessary.
Manage technology development and production of novel pMHC reagents to enable target identification, target validation and TCR affinity maturation for both oncology and/or autoimmune indications.
Drive team engagement, ownership, and agility to deliver ambitious results.
Author and review technical documents and reports for inclusion in CMC sections of regulatory filings.
- Qualifications/Experience
- Academic/PhD degree in Biochemistry, Biology, Bioengineering, Immunology, or related discipline.
- Proven experience leading and managing lab teams within complex programs to drive functional and corporate goals.
- Minimum 8+ years’ experience in pharma/biotech industry with management experience in process development.
- Production experience with proteins expressed and refolded from E. coli and with proteins expressed in mammalian cells with oversight of both upstream and downstream process development.
- Experience in research strategy development and operational management of research outcomes through cross-functional and outsourced teams, as well as budget planning and management.
- Technical report writing for inclusion in regulatory submissions.
- Desirable to have experience with bispecific protein products.
- Ability to drive strategic discussions with senior level management and external partners.
- Experience in building practical creativity in teams to persist and respond positively to changes.
- Experience in collaborating across teams to resolve problems with strategic and operational impact on individual, function, and corporate performance.
MUST HAVE EXPERIENCE:
Refolded E. coli experience (Ideal)
- If no E. Coli experience, must have
- Experience w/ Recombinant protein
- Experience with bispecific protein products
- Strong process development background
- Tech Transfer experience - working with CDMO
- Strong Communication and Leadership experience. Must have previous management experience and ability to speak to management style
Salary Range: $165-180K/yr