Senior Manager, Analytical Development (Small Molecule)
Site Name: USA - Massachusetts - Waltham
Posted Date: Sep 10 2019
The Senior Manager, Analytical Development will support the analytical development function of GSK's small molecule portfolio of product development candidate(s) using an outsourcing model. The individual will participate in the creation of CMC development strategies, integrating analytical development requirements with the cross-functional CMC plan and in alignment with the Core Program Team objectives. S/he will have responsibility for the oversight of outsourced analytical development activities pertaining to small molecule drug substance process and drug product formulation development, and product characterization.
- Manages the development, validation and implementation of appropriate analytical methods in support of drug substance and drug product development across all stages of development.
- Manages the method transfers and implementation of appropriate analytical methods in support of drug substance and drug product in external laboratories/partners.
- Manages the technical oversight, and timeline of outsourced analytical activities in alignment with program objectives.
- Applies technical expertise to support the development of new formulations, synthetic routes, and manufacturing processes with appropriate analytical characterization and testing methods.
- Ability to analyze results and methods, solve analytical problems, troubleshoot assays and meet regulatory expectations for analytics applied to small molecule drug substances and drug products.
- Assist in the drafting and review of technical and GMP documents (e.g., analytical protocols, reports, SOPs) as well as supporting the preparation of CMC documents for regulatory filings.
- Reviews and approves vendor protocols and reports.
- Prepares method transfer/validation protocols and reports, and analytical data sets.
- Manages relationships with existing CMO's in support of analytical development of stage appropriate analytical procedures for release and stability testing of drug substances and drug products.
- Helps identify suitable CMOs with needed analytical development competencies; provides input for proposal generation.
- Collaborate with GSK's internal CMC teams and associated CMO/CRO organizations to enable the completion of planned analytical activities in accordance to agreed scope, timing and budget.
- MS or PhD in Analytical Chemistry, Pharmaceutical Chemistry or related field, with 7+ years of experience in analytical development or 5+ years of experience in pharmaceutical development.
- Experience with analytical technology as applied to small molecule pharmaceuticals (both drug substance and drug product)
- Analytical development experience for both early and late stage molecules
- Knowledge of analytical testing concepts and current cGMPs including laboratory controls and good documentation practices
- Experience building relationships with and working with CMOs
- Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations
- Ability to travel and work a flexible schedule to accommodate program priorities as needed
- Ability to draft scientifically sound analytical reports
Please use the cover letter to highlight how you meet the competencies for the role. Your cover letter along with your CV will be used to assess your application. Thanks for your interest in this opportunity.
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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