Associate Director - Upstream Process Development & Manufacturing

Location Boston
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: On application
Contact name: Sam Murphy

Contact email: sam.murphy@rbwconsulting.com
Contact phone: 16179821238
Job ref: SM-ASDI-UPDM-BMA-150321
Published: 26 days ago
Expiry date: 15 April 2021

​Reporting to the Senior Director of Upstream Process Development and Manufacture, the Senior Manager/Associate Director, Upstream Process Development and Manufacture will be responsible for managing and supporting the upstream development and manufacturing activities of late-stage programs, including phase 3 process development, tech transfer, GMP manufacturing, on floor support, process characterization, process validation and BLA-enabling studies. It extends further to the preparation of CMC content for regulatory submissions and correspondences.

The incumbent will oversee the planning and execution of outsourced CMC activities, and work proactively with service providers to define project scope and ensure successful delivery with regard to technical quality and timeline. S/he will contribute to the identification and selection of CROs and CDMOs and building/maintaining strong working relationships with their respective technical staff and management. S/he will also manage the tech transfer activities between various manufacturing sites, provide on floor support during GMP manufacturing operations and work with internal lab to design and execute development studies.

Responsibilities (including but not limited to):

  • Manage and support upstream development and manufacturing activities of late-stage programs, including phase 3 process development, tech transfer, GMP manufacturing, process characterization, process validation and BLA-enabling studies

  • Lead tech transfer activities between various manufacturing sites and provide on floor support during GMP manufacturing operation

  • Collaborate with internal lab to design and execute development studies

  • Provide technical input for the development and scale up of robust upstream processes

  • Author and review CMC documentation for regulatory filings

  • 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 analyses 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 teams regarding progress against technical objectives/milestones

  • Ensure well-organized, clear and complete records of all activities across areas of responsibility

  • Approximately 5-10% of domestic and/or international travel

Qualifications:

  • Requires a PhD in chemistry, biochemistry, (bio)chemical engineering (or other relevant physical or life sciences discipline), or MS with equivalent education with and 5+ years of biologics drug development leadership experience in pharma/biotech

  • Significant experience in the areas of upstream process development, tech transfer, GMP operation, process characterization, process validation and BLA-enabling activities

  • Expert knowledge of protein purification unit operations and process technologies (e.g., centrifugation, filtration, chromatography, 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

  • Knowledge of cGMP regulations

  • Experience in preparing and defending regulatory documents (BLAs/NDSs/MAAs) a plus

  • Experience and knowledge in process validation highly desired Excellent team building, leadership and management skills

  • Excellent communication and interpersonal skills fostering team spirit

  • 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 in order to maintain a high level of productivity, innovation, and priority setting in order 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, and results-oriented

Salary: On application