Senior Director - Biologics Development - Synageva BioPharma - Lexington

Job description
This position will be responsible for leading, building, and managing an early stage recombinant protein therapeutic development group.
The successful candidate will lead a group of scientists and research associates and be responsible for the management and leadership of multiple development and technology projects, providing both technical oversight and strategic guidance in a fast-paced environment.

Specific responsibilities include:
Manage group responsible for transient and stable expression of heterologous proteins in mammalian cell culture. Ensure developed cell lines and cell banks meet productivity and quality metrics required for IND enabling human toxicity studies.
Manage and provide directionality to mammalian cell protein expression and purification activities. Develop purification strategies that are transferable to Process Development.
Coordinate and manage key activities related to the delivery of purified, formulated proteins to support protein characterization and pharmacological profiling for multiple early stage programs.
Maintain and develop a cutting edge understanding of relevant methodologies to ensure group is at forefront of biologics development
Apply innovative technical ability and knowledge to critically analyze the experimental results and literature findings.

Work with Early Stage Analytical Development to develop required test methods to support early stage biologics development including purification, formulation, and characterization.
Recruit bioprocess development and biologics scientific talent to develop a high performance team to conduct early stage protein therapeutics, development from product selection, cell line construction to proof of concept material production.
Set clearly defined objectives and business goals and lead team to ensure high quality execution to accomplish critical deliverables
Provide clear regular communication to senior management on progress of projects via presentations and reports.
Maintain well-organized, clear and complete records of all activities across areas of responsibility
Develop, maintain, and improve SOPs for each generated cell line and produced proteins to ensure rapid adoption and modification for Process Development
Lead, coordinate and manage outsourced contracts to CROs as needed
Maintain the site, processes, SOPs, and personnel for ease of developmental transfer.
Manage and execute personnel qualification/training program.
Manage and select multiple expression platforms to meet specific preclinical program goals and objectives.

Desired Skills and Experience
JOB REQUIREMENTS AND QUALIFICATIONS:
A Doctorate (Ph.D., D.Sc.) in Biochemistry, Chemistry or Life sciences, or equivalent education or experience is required.
10+ years of experience in Biologics Discovery in biotech or pharma. Experienced in protein expression, isolation, and characterization of heterologous glycoproteins.
Knowledge of and experience with production of recombinant proteins using mammalian cell lines and other expression platforms in a research and development biologics setting
Knowledge of and experience with protein purification techniques for purposes of moving biologics programs through proof of concept and preclinical studies
Hands-on experience with unit operations such as lab and pilot-scale bioreactor operation, centrifugation, clarification, formulation, chromatography and filtration.
Demonstrated ability and experience in effectively managing groups and developing people.
Possesses strong collaboration and communication skills and the ability to build and maintain relationships with partners, customers and collaborators. Fosters teamwork and actively participates in the review of projects with colleagues throughout the company.
Demonstrated ability to lead innovation, change and drive for results.
Strong track record of strategic prioritization, innovative thinking and good decision making.
Effective communicator of ideas, project goals and results.
Excellent verbal and written communication skills for effectively interfacing with internal and external organizations.
Ability to handle multiple assignments in a fast-paced environment with changing priorities.
Competency in MS Office, Adobe Acrobat, and specialized laboratory software for vector and protein engineering
Ability to travel as needed, not to exceed 15% (domestic).

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