Director, CMC Biologics and Sterile Engineering and Technical Services
- Waltham, MA
Site Name: USA - Massachusetts - Waltham
Posted Date: Jun 15 2020
- Provide engineering leadership in support of oligonucleotide Active Pharmaceutical Ingredients (API) development programs.
- Collaborate and coordinates in cross-functional teams, both internally and at CRO/CMOs, to develop robust, scalable, cost effective and safe processes.
- Work closely with CMO production and maintenance for the evaluation, scale-up and implementation of new equipment and processes.
- Develops, validates, and implements processes for Oligonucleotide Synthesis, Deprotection, Purification, and Isolation in a high throughput production environment.
- Manage technology transfer of developed manufacturing processes to appropriate CRO/CMO facilities by ensuring the suitability of selected equipment trains and adaptation of process parameters.
- Assist in due diligence efforts to assess technical capabilities for vendor selection and preparation of request for proposals.
- Establish and maintain an understanding of current trends, emerging process technologies and ensure full awareness of current and emerging global capabilities for oligonucleotide production.
- Recommend process improvements aimed at maximizing capacity utilization and reducing the cost of API production through process optimization; lead implementation at CRO/CMOs where appropriate.
- Partner with project stakeholders to apply and execute Quality by Design (QbD) principles to define the design space and develop overall control strategy. Construct and manage controlled experiments to screen, optimize, and scale chromatographic and synthetic chemistry processes.
- Troubleshoot new and existing product or process issues related to yield, quality and throughput, utilizing structured problem-solving techniques and quality assurance mechanisms when appropriate.
- Develop assessments and strategies for identifying, managing, and reducing product / process risk utilizing a variety of techniques including Technical Risk Assessments, FMEAs, DOEs and Control Plans.
- Develop technical summaries and provide assistance for regulatory filings.
- Analyze process test results, issue reports and make technical recommendations.
- Presents results and progress of CMC programs to internal and external audiences as appropriate.
- Manage process capability in respect to the overall needs of the project(s), driving a solutions based approach to address yield and quality issues in a regulated production environment.
- Create, review and approve technical documents including batch records, engineering / development reports, and risk / validation assessments.
- Ph.D. in bio/chemical engineering, chemistry, biochemistry (or other relevant physical or life sciences discipline) with 10+ years of experience in oligonucleotide drug development biotech or pharma industry, with significant experience in the areas of isolation, purification, process characterization, process validation and product life cycle management or BS/MS with equivalent education or experience is required.
- Demonstrated history working in a virtual CMC development/commercialization environment working with CMC partnerships with global providers.
- Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration a multi-disciplinary business and science team environment is essential.
- Personal attributes: self-starter; attentive to details; results oriented; accountable; committed while maintaining balance and perspective. Others will describe you as honest, trustworthy, and respectful of others; a person of high integrity, a good listener, a straightforward communicator, and a team builder.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
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