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: 26 days ago
Expiry date: 15 April 2021

​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