Sr. Dir., Bacterial Vaccines, Process & Analytical Development job in Gaithersburg, USA

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Job type: Permanent

Discipline: Senior/Director & VP, Analytical Chemistry, Biological Sciences

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Senior Director, Bacterial Vaccines, Process & Analytical Development to join a global pharmaceutical company located in Gaithersburg, MD.

This individual will lead a team of scientists developing methods to produce bacterial vaccines for early research and development programs. The team will employ specialized molecular biology methods to optimize expression of bacterial carbohydrates, proteins and bioconjugate vaccines in bacterial expression systems and develop robust, scalable purification methods to transfer for scale-up in Bioprocess Development. The role will be responsible for influencing senior internal partners in Research, Bioprocess Development and Regulatory Affairs and lead external academic collaborations and contract manufacturers to deliver novel vaccines.

Must be eligible to work in the US.

Job Responsibilities:

Develop robust expression, purification, and formulation methods for a portfolio of bacterial vaccine projects from target discovery through clinical stage product development ensuring cross-functional alignment.
Lead team to deliver methods for optimized expression / fermentation, purification and formulation of candidate vaccine antigens including bacterial carbohydrates, carbohydrate bioconjugate vaccines, protein subunit and novel antibacterial vaccine platforms
Establish strategic partnership with Bioprocess Development to develop scalable, robust processes to ensure an effective transition from research to clinical development and commercialization.
Oversight and accountability of partnerships with third parties, academic or contract manufacturers
Develop internal and external partnerships to fully characterize purified vaccine antigens including carbohydrates, carbohydrate conjugates and proteins antigens
Build and nurture effective relationships with senior and executive collaborators in Research, Bioprocess Development, Clinical and Translational Medicine and Global Project Teams to ensure alignment across functions
Responsible for ensuring all projects within their area and their teams clearly and objectively communicate results, as well as their associated risks, uncertainties, and limitations
Define the training standards for junior colleagues in line with established standards and principles

Skills and Requirements:

PhD with 5+ years or BS/MS with 10+ years experience in microbiology, carbohydrate chemistry, protein biochemistry, molecular biology, biochemistry, or a related subject area/field
Experience leading and mentoring junior colleagues
Experience developing methods to purify bacterial vaccine antigens including carbohydrate conjugates, carbohydrate bioconjugate and/or protein subunit vaccine
Experience with methods to characterize quality of bacterial vaccine antigen structure and function
Experience working in a cross-functional team to optimize and transfer methods for scale-up of bacterial vaccine production
Experience designing and implementing novel methods to support vaccine development
Experience supporting or leading interdisciplinary vaccine discovery or development programs
Experience developing and controlling budgets
Excellent written and verbal communication, business analysis, and consultancy skills
Experience working with and leading scientists across subject areas
Familiarity with fermentation to optimize carbohydrate or recombinant protein expression
Proven track record of publishing relevant results and tools in peer-reviewed journals, conferences, and other scientific proceedings.
Experience in life sciences and healthcare
Experience in novel methods development and application
Experience in a sophisticated global organization

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC

Salary

Highly Competitive Salary

Location:

Wrexham, Wales

Proclinical is seeking a Senior Principal Scientist to lead strategic projects in biomanufacturing processes, focusing on API/Drug substance processing.