Job Description
Job Summary
POSITION SUMMARY
The Director, BioSimilars Lab is responsible for the operation, leadership, and direction of Lab Operations dedicated to biosimilars development. The incumbent will build and lead a dynamic team of experienced scientists, providing expertise and leadership in all associated aspects of characterization technologies used in support of the development, heightened characterization and commercial manufacturing of recombinant proteins.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
Create lab unit dedicated to biosimilars development, including hiring, equipment purchases, installation and qualification
Develop platform to perform routine techniques such as: Size Exclusion, Bioassay, Reverse Phase, Ion Exchange, Hydrophilic Glycan Chromatography, (imaged) capillary electrophoresis and PAGE, Differential Scanning Calorimetry, Spectrophotometry.
Manage and build a growing group of scientists dedicated to biosimilars, and oversee work performed
Propose and implement analytical outsourcing strategy, balancing opportunities and risks. Oversee work done in collaboration with CROs in the areas above and on methods such as: 2D/3D structure, excipient testing, compendial testing.
Keep abreast of technical development to maintain a state-of-the-art technology platform
Review, edit, and approve internal reports supporting regulatory submissions
Can act as team member in Development teams
Manage performance and development of personnel to ensure achievement of organizational and department goals as well as motivation for high productivity
Manage budget, resource allocation, and resource forecasting, and monitor and control expenditures against the department budget
Develop analytical control strategy and support regulatory filings.
Partner with the stakeholders and SMEs to align on priorities, resources, support and expertise as required
Actively maintain knowledge of industry best practices related to bio-, binding and immunoassays and relevant technology
Enable effective utilization of resources by ensuring robust employee development and performance management practices in area of responsibility
Additionally:
Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.
Responsible for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards.
Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001.
REQUIREMENTS
PhD in Biochemistry, Analytical Chemistry, Cell Biology or related field with 10+ years relevant industry experience; MS with 15+ years of industry experience in Pharma/Diagnostic industry required
7+ years' experience with bioassays and immunoassays
5+Years' experience in managing direct reports
Proven track record of heading bioassay development for biologics, leading teams while managing multiple projects, experience building team and lab is highly desirable
Demonstrated ability to lead programs and/or projects, ability to influence and must have strong communication skills.
Recognized Thought leader and strongly networked in the field of bioassays, binding and immunoassays.
Familiarity with microbiological safety and viral clearance aspects of bio-manufacturing and control and testing strategy
Demonstrated leadership capabilities to develop a high performing team, drive change and influence internal and external stakeholders.
Demonstrated and significant experience with bioanalytical methods, such ELISA, cell-based reporter assays, antibody effector function assays and viral assays.
Excellent verbal and written communication skills required
Ability to understand and interpret federal regulations and company operating procedures
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.