Manager, CMC Vx Development Projects Details

Manager, CMC Vx Development Projects

GSK - Rockville, MD

Employment Type : Full-Time

Site Name: Belgium-Wavre, Italy - Siena, USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville
Posted Date: Mar 30 2021

Are you seeking an opportunity where you can lead through influence using your expertise? If so, this Manager, CMC Vx Development Projects role could be an exciting opportunity to explore!

This role will provide YOU the opportunity to progress YOUR career, these responsibilities include some of the following…

• Identifies risks associated with submission data and information packages.
• Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, policies and systems Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, policies and systems

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in Sciences or Medical Sciences
• 0-3+ years of relevant industry experience in product development

• Experience managing multiple projects simultaneously.

• Knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.

If you have the following characteristics, it would be a plus:

• Master’s degree or above in Chemistry, pharmacy, biological or closely related science advanced degree.

• Regulatory Affairs Certification (e.g. RAPS).

• Demonstrated ability to handle global CMC issues through continuous change and improvement

• Experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of leadership in a matrix environment.

• Sound knowledge of vaccines/biological products development, manufacturing and supply processes.

• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.

• Identified as CMC Regulatory expert in a specific subject area.

• Highly developed interpersonal, presentation and communication skills.

• Proven experience in training staff within an organisation.

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.

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.

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