GSK

CMC Leader

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Posted
July 30 2021
Ref
297779
Discipline
Other, Other
Organization Type
Pharma
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jul 30 2021 CMC Leader Upper Providence Are you interested in a highly visible leadership role, supporting our innovative portfolio of early phase small molecule assets? This opportunity will allow you to influence the medicine development strategy; lead delivery of the CMC, supply chain and regulatory targets; lead the high performing matrix team; and shape the medicine and patient experience. If so, this CMC Leader role is an exciting move to explore. The role: This is a key leadership position in GSK, defining and delivering the early CMC development strategy and plan for a new medicine. The successful candidate will join the CMC Leader team, taking on a number of significant assets. Key responsibilities: Leads CMC development of a medicine: Leads the definition and implementation of the early CMC development strategy and provides options for CMC delivery to align with the project objectives, with recommendations based on sound judgement on both short- and long-term implications (risks, costs, resources and time) for the early development of the medicine. Leads the CMC matrix team: Leads the cross-functional multi-disciplinary CMC matrix team to develop and execute the CMC project plans to accomplish the project aligned objectives to time, budget and resource forecasts. Owns the performance of the CMC matrix team: partners with line managers to appropriately resource the project with the right expertise, and to develop and support the core and extended team members to drive performance and deliver the project. Scope of activities covered by CMC matrix team: Development of the physical product, process, device and analytical methods Establishment of the early clinical supply chains and manufacturing processes Supply of clinical material and clinical pack and label Definition and delivery of the CMC regulatory strategy, submissions and responses to regulatory questions Voice of CMC for the project: Provides the voice of the physical product and supply chain to influence the early medicine development strategies and plans. Provides the voice of the project to the CMC matrix team to align the CMC plans with the project intent, and to the CMC functional lines to ensure they have the capability and capacity to deliver. Skills and competencies This role requires the knowledge, courage and credibility to lead a high performing multi-disciplinary matrix team of CMC experts to develop and deliver the manufacturing process, supply chain, physical medicinal product and regulatory submissions to enable early clinical trials. An exceptional matrix leader: Sets direction, empowers others to take ownership of their activities, monitors progress, knows when and how to intervene to avoid or manage risks and issues, helps remove barriers, holds team members accountable for their delivery and performance on behalf of the team. A curious scientific intellect, a critical thinker with sound judgement Strong decision-making skills An agile and willing learner Creative problem solver: able to analyse and interpret complex situations to provide appropriate innovative solutions and clear strategic direction to others An active and empathetic listener who is aware of own limitations in knowledge, expertise or experience Able to influence at all levels in the business and across multiple disciplines Masterful manager of conflict Collaborative, cooperative, inclusive and transparent, builds and cultivates high performing teams and partnerships Excellent communicator both verbal and written A highly credible CMC expert: Strong technical knowledge of process, product and analytical development Awareness of compliance and regulatory requirements for clinical manufacturing Advanced knowledge of the drug development process Awareness of CMC as part of the whole, with a broad knowledge of the end to end non-clinical, clinical, regulatory aspects of developing a medicine Analyses, interprets and critically evaluates data and information to determine and justify decisions or recommendations Experience Significant experience working in a CMC organisation Recognised internally, and preferably externally, as a thought leader or subject matter expert in a relevant CMC discipline Experience in CMC medicine development, particularly early stage Successful developer of people as a mentor, coach, matrix or line leader Successfully led large, complex, cross-functional teams, with high level of accountability, preferably in an international context and preferably with external partners Why you? Basic qualifications: Bachelor of Science with extensive CMC experience in the development or manufacture of relevant pharmaceuticals Excellent knowledge, through experience, of the relevant CMC and supply chain aspects of developing, manufacturing pharmaceuticals along with a thorough working knowledge of the pharmaceutical industry, relevant regulations and requirements Experience creating and defending CMC development strategy, plan and data package for an asset in early development Project leadership experience, specifically leadership of multi-disciplinary teams and preferably in a relevant pharmaceutical product development environment with global teams Experience working at a senior level with both internal and external groups Preferred qualifications: PhD with extensive CMC experience in the development or manufacture of relevant pharmaceuticals Learning agility and desire to learn new things outside of one's comfort zone; willingness to take on diverse and challenging assignments in product development Why GSK? At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best. When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing. Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers. When applying for this role, please use the ‘cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.  If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. 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 Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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