Senior Manager, Biophysical Analytical Development

Role

• Define an Analytical Development strategy, incorporating phase appropriate and risk based approaches, which clearly tie solutions to business and scientific problems

• Manage the validation and technical transfer of state-of-the-art analytical techniques in support of advanced characterization of Resilience nucleic acid-based products

• Establish leadership across multiple working groups and with regulatory agencies to advance Resilience’s nucleic acid manufacturing goals

• Interface directly with partners to evaluate requirements and identify opportunities within development programs

• Lead a team of junior scientists and engineers in the development of novel analytical methods, acting as a technical expert in chromatography and biophysical characterization method development.

• Collaborate with analytical groups in other Franchises to develop best practices and create a center of analytical excellence

The Nucleic Acids Franchise will be temporarily based in Allston, MA. The Nucleic Acids Franchise will relocate to the Bedford, MA area in 2022.

Job Responsibilities

• Provide analytical characterization support within the Resilience organization and with external groups

• Development and qualification of analytical methods for nucleic acid testing

• Provide guidance and expertise in mass spectroscopy, analytical chromatography, sequencing methods (Sanger and NGS), PCR, qPCR.

• Experience with enzymatic reaction systems, bio-conjugation

• Utilize external networks to maintain and enhance current knowledge of emerging technologies in bioanalytics to support improvements for existing analytical strategies.

• Responsible for building and managing Resilience’s analytical group, including talent recruitment.

• Communicating technical information to internal and external partners.

• Writing and reviewing technical documents and regulatory submissions

• Manage and lead a team of 2-4 direct reports

Qualifications

• Strong scientific background with extensive hands-on experience in a broad array of biochemical/biophysical techniques is required.

• Extensive experience with experimental design, data analysis, organization and presentation of complex scientific data.

• The candidate should be a self-starter, critical thinker, and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.

• Established external network of service providers, technical experts, suppliers, and technology providers.

• Ability to recruit, lead, manage, and motivate a diverse team across various functions. Demonstrated ability to work efficiently across multiple project teams and business functions

• Experience with developing analytical methods in compliance with USP/ICH guideliness

Preferred Experience

• PhD and a minimum of 5 years experience or MS and a minimum of 8 years experience in nucleic acid related assay development

• Demonstrated experience managing teams in a matrix environment preferred.

• Excellent written and verbal communication skills.

Other Ideal Personal Characteristics

• Hungry, humble, and a learning machine with an open, inquisitive mind with regard to the future of medicine and biomanufacturing

• Embodies grit, rigor, service, EQ+IQ, builder mentality, velocity, and ownership

• Smart, curious, flexible, able to contribute at a very high level, as well as possessing a hands-on manner, when necessary

• Collaborative style, with an ability to build consensus among both internal and external stakeholders

• A person of unquestioned integrity and moral character; an individual that others can trust without reservation