Manager, Drug Product

Vaccitech plc is a fast-growing biotech company. At only six years old we already have a development portfolio of nine programmes, including a partnered product that is in commercial production and that has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly listed clinical stage biopharmaceutical company that spun out of the University of Oxford’s Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases, cancer, and autoimmunity. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We run clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.

In December 2021, Vaccitech acquired Avidea Technologies Inc. with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us U.S operational presence in Maryland, complements Vaccitech’s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. Vaccitech's UK headquarters has recently moved to a state-of-the-art facility in the UK's leading science and innovation campus at Harwell. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.

Job Summary:  Manager role will act as a key member of the manufacturing team for parenteral dosage forms using QbD principles.  Reporting to Head of manufacturing, peptides, the candidate will independently work with CDMOs for the preparation and timely delivery of peptide drug products (DP), processes, and procedures needed for technology transfer and manufacture of peptide drug product.

Responsibilities:

• Responsible for managing formulation development, tech transfer and manufacturing activities at the CDMOs of peptide drug products.
• Work with CDMOs to Design and perform quality scientific experimentation to develop robust processes in support of Formulation / Process Development activities.
• Analyze and defend scientific results from experiments, design, and conduct stability studies, generate accurate, reliable data by following established protocols and practices to support product development, and summarize, interpret, report, and results.
• Represent the Parenteral Formulation group (peptides) to interact with both internal and external stakeholders.
• Work independently, recognize and address key issues likely to affect the successful and/or timely completion of tasks and projects.
• Communicates effectively to the management team, project manager, and the wider development team and presents data at team meetings and departmental technical meetings.
• Author, review and strategically impact regulatory filings (including INDs, IMPD, briefing packages and other regulatory dossiers) and updates.
• Review batch records and approve technical documents (e.g., non-GMP/CGMP documentation with CDMOs).
• Manage priorities, and project timelines by devising new possibilities and practicing the best practical technologies, including the use of QbD and PAT where appropriate.
• Set high standards on deliverables while managing risks such that maximum benefit is achieved on projects/programs.

Qualifications:

• Ph.D. with at least 8 years of related technical experience, or a master with 12 years of experience, required within the biopharmaceutical industry.
• Comprehensive Knowledge of the principles and practices of pharmaceutical sciences combined with professional experience in developing and testing peptide parenteral formulation processes. 
• Excellent Writing skills as they relate to preparation of RFPs, RFQs, protocols, and reports.
• Understanding of cGMP requirements, ICH, and regulatory guidance.
• Familiarity with Quality and Regulatory Affairs as applicable to CDMOs compliance and regulatory filings.
• Sound problem-solving skills and good scientific judgment are required.
• Effective written and oral communication skills, as well as presentation skills
• Able to efficiently manage uncertainty, changes in priority, and timeline restrictions.

TECHNICAL KNOWLEDGE REQUIRED:

• Familiar with the state-of-the-art equipment used in Drug Product manufacturing and analysis.
• Software Knowledge: JMP® Software, Windows, MS Office (Outlook, Word, Excel).

Travel requirements:

• Up to 25% travel

What we can offer you

Vaccitech is a great place to work. We encourage an entirely flat structure with an open door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. We offer employer funded health, dental and vision insurance; a 401k retirement plan; career development opportunities and paid time off (PTO). Salary will be commensurate with experience.

Notice to recruiters

Vaccitech’s internal Talent Acquisition leads recruitment and employment for Vaccitech. Unsolicited resumes sent to Vaccitech from recruiters do not constitute any type of relationship between the recruiter and Vaccitech and do not obligate Vaccitech to pay fees should we hire from those resumes. Vaccitech operate a preferred list of recruitment suppliers, any and all equiries about joining us as a supplier should be directed to Vaccitech’s TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.