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Manager, CMC Vx Development Projects

Employer
GSK
Location
Rockville, Maryland; Siena, Italy; Collegeville, Pennsylvania
Salary
Competitive
Closing date
May 7, 2021

View more

Discipline
Other, Other
Job Type
Manager
Organization Type
All Industry, Pharma
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


Why you?

Basic Qualifications:

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.


Preferred Qualifications:

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.



Why GSK?

Our values and expectationsare 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.

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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