Head of Analytical Operations (Oncology)
Site Name: USA - Massachusetts - Waltham
Posted Date: Jan 15 2020
Head of Analytical Operations- Oncology
The Head of Analytical Operations, US is ultimately accountable for the development of robust analytical methods and associated specifications for both small and large molecules developed within the Strategic External Development organization. The team the person will lead is responsible for the generation of high-quality, on-time, and right-the-first-time data that comprise a critical component of regulatory submissions required to enable the clinical and/or commercial use of GSK products. The analytical data generated by these methods ultimately ensure the safe and effective use of our drug products in healthy volunteers and/or patients and ensure the continuity of supply of these drugs to patients.
DUTIES & RESPONSIBILITIES:
The successful applicant's responsibilities will include:
- Build and maintain strong relationships with external partners to effect successful analytical strategies are positioned and implemented for the pipeline molecules in the strategic external development organization
- Provide leadership, guidance, and strategic direction to a group of analytical chemists on all aspects of analytics for all projects residing within the group and ensure staff are developed to their fullest potentials by providing coaching, mentoring, and appropriate learning opportunities to optimize leading analytical sciences in a virtual setting
- Ensure efficient and top-notch development, utilization, and transfer (into PSC or external supplier(s)) of high-quality and optimized analytical methods and associated specifications for drug substances and/or drug products that meet or exceed the expectations of internal partners and external regulators and that ensure the high and consistent quality and performance of drug substances and/or products.
- Oversight of our partner network to ensure right-the-first-time analytical testing at our partner/contract facilities that allow for the on-time release of drug substances and/or drug products by Quality Assurance for clinical use.
- Ensure that external partners are delivering high-quality and timely analytical data to support clinical programmes
- Working with all partners across PDS, BPDS, CMC Regulatory Affairs, and PSC, the department director will ensure on-time delivery of high-quality CMC packages for submissions that meet or exceed the expectations of external regulators and that lead to first-cycle approvals.
- Ensure that the group leads our external partners to closes out Quality Incidents, Corrective and Preventive Actions, Deviations, and Customer Complaints in a timely manner.
- Implement a continuous improvement plan to ensure that activities performed by the group are in compliance with current regulatory expectations in the markets of interest and are at the leading edge of analytical sciences
- Ensure the work conducted by external partners and the group is performed in accordance with GSK and external regulatory quality standards in the markets of interest and is also conducted in accordance with GSK and local EH&S standards and embrace inclusion and diversity to create and modern and dynamic working environment across the function.
- Ensure function meets agreed performance, throughput and quality targets and that resourcing is aligned to R&D priorities
We are looking for professionals with these required skills to achieve our goals:
- PhD or equivalent industry experience
- Extensive experience with the Pharmaceutical Industry, ideally in building relationships and leading virtual CMC philosophies to deliver sound analytical control strategies for pharmaceutical starting materials, intermediates, active ingredients and drug products.
- Scientific knowledge in both small molecule and large molecule methodology and strategies.
- Proven track record of regulatory writing and approvals
- Demonstrated experience in specification setting and selection of analytical methods
- Experience of non-regulated, GLP and GMP processes necessary to develop a medicine ready for commercial release and supply to the clinic.
- Strong understanding of product development disciplines and relationship of analytical testing to drug development
- Track record of delivering high-quality analytical solutions and data that meet or exceed customers' expectations
- Proven ability to effectively lead a group of analytical or pharmaceutical scientists
- Demonstrated effective interpersonal, communications, influencing, and negotiation skills across internal and external (e.g. PSC) stakeholders and senior managers
- Ability to analyse trend and metrics data (especially related to quality, safety, technical requirements and performance) to drive continuous improvement
- Ability to effectively handle and appropriately escalate issues based on risk in a timely manner.
- Ability to effectively coach and mentor group members
- Knowledge of IVD/diagnostics development
- Experience in managing research collaborations, contract laboratories and budgets
- Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
- Effective verbal and written communication skills relating to colleagues and associates both inside and outside the corporation
- Ability to productively collaborate with multiple groups in a matrix environment
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:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritisation, execution, delivering performance.
- Setting strategic direction and leading on-going organisational transformation.
- Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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