Director/Associate Director
Location | Boston |
Discipline: | Regulatory Affairs |
Job type: | Permanent |
Salary: | £Salary: On application |
Contact name: | Sam Murphy |
Contact email: | sam.murphy@rbwconsulting.com |
Contact phone: | +1 (617) 982 1238 |
Job ref: | 20971 |
Published: | about 3 years ago |
Expiry date: | 26 Jul 2023 11:59 |
Location: MA area / Boston - USA
The Director/Associate Director, Downstream Process Development will represent downstream in cross-functional teams, support leadership team in defining and executing against short-, intermediate- and long-term strategic goals. S/he will also contribute to shaping and defining overall strategies for downstream development and manufacturing.
Job Responsibilities:
Provide technical leadership, management and oversight for the development, scale up, tech transfer, process characterization and execution of robust downstream processes.
Author and review CMC documentation for regulatory submissions.
Establish and maintain an understanding of current trends and emerging downstream process technologies to ensure that team is at the forefront of biologics development.
Apply innovative technical ability and knowledge to critically analyze experimental data and results.
Set clearly defined goals/objectives to ensure delivery of high-quality results.
Provide clear communication to functional line management and cross-functional team regarding progress against technical objectives/milestones.
Ensure well-organized, clear and complete records of all activities across areas of responsibility.
Approximately 10% of domestic and/or international travel required.
Education and Experience:
Ph.D. in chemistry, biochemistry, (bio)chemical engineering (or other relevant physical or life sciences discipline) or MS with equivalent education or experience.
7+ years of experience in biologics drug development, with significant experience in the areas of purification process development, scale up tech transfer and process characterization.
Expert knowledge of protein purification unit operations and process technologies (e.g., filtration, chromatography, TFF etc.) and experience in advancing biologics processes through clinical development to successful regulatory approval/licensing.
Knowledge of and experience with production of recombinant proteins using mammalian cell lines.
Experience in managing external vendors and manufacturers.
Experience in preparing and defending regulatory documents (IND/CTA/BLAs/NDSs/MAAs).
Knowledge of cGMP regulations.
Experience and knowledge with viral clearance studies and PPQ is a plus.
Competency Expectations:
Excellent team building, leadership and management skills.
Excellent communication and interpersonal skills. Great team player.
Strong technical/analytical skills to identify and solve problems.
Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
Proven ability to work with a high level of integrity, accuracy, and attention to detail.
Strong organizational skills for high productivity, innovation and priority-setting to complete assignments on-time and on-budget.
Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making.
Resourceful, creative, enthusiastic, proactive and results-oriented.
Salary: On application
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