CK Science are looking to recruit a CMC technical expert with experience in neurodegenerative diseases for our client based in Massachusetts on a permanent basis.
You will be the primary technical lead for process validation, process improvements, technical transfers, and ongoing manufacturing technical support. Working in conjunction with a cross-functional team, you will participate in the long-term CMC Asset strategic plan development and ultimate implementation of activities to meet long range forecasts, reduce supply risks, improve processes, reduce COGS, and support global expansion.
- Small Molecule Drug Product and Packaging process support - troubleshoot process issues, monitor and evaluate process data, identify adverse process trends and improvement opportunities.
- Quality System Support - lead consistent and well documented response to process operations events including investigations, deviation closure as well change control/CAPA as appropriate.
- Technical SME and process owner - author, review, and approve regulatory and technical documentation, including but not limited to NDA, annual product reports, SOPs, Validation Master Plans and Technical Reports, act as the technical lead for regulatory submissions and inspections and audits.
- Continuous Improvement - work with CMOs to identify opportunities to improve the consistency and robustness of process operations.
- Provide technical leadership for vendor selection, process transfers and validations.
- Manage external resources including Consultants and Contractors, as needed to deliver projects.
- Bachelor\'s in Biology, Chemistry, Chemical Engineering, or related field with a minimum of 5 years\' experience supporting small molecule large scale unit operations
- Process Validation experience
- Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations and product impact assessments
- Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges
- Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents
- Experience working with contract manufacturing organizations
- Excellent communication and teamwork skills
- M.S. and/or Ph.D.
- Experience in:
- Formulation and/or process development
- Packaging operations
- Global regulatory filing and approval
- Participation in new drug application preparation
For more information, please contact Rob Angrave on +1 (617) 6922948 or email firstname.lastname@example.org. Please quote 50147 in all communications.
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- Agency: CK Group
- Contact: Robert Angrave
- Phone: 0191 457700
- Reference: 50147
Website: CK Group
- Posted: 1st July 2021
- Expires: 29th July 2021