Drug Substance Production Supervisor

Reference #: 405394

Site Name: USA - Pennsylvania - Marietta

Posted Date: Oct 3 2024Are you looking for an opportunity to lead the production planning delivery within the safety, quality, planning and budget in a complex and highly regulated environment? If so, this is the role for you.As Drug Substance Production Supervisor, you will provide leadership of a team providing, timely cost-effective delivery of drug substance to the customer.

This includes supervising the team to meet required safety, quality, compliance and delivery targets of our commercial product and ensuring manufacturing operations are executed in cGMP compliant manner and meeting company standards. As a member of the Manufacturing leadership team, you will be responsible for departmental and site objectives.This role will give YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Responsible for application of approved EHS and Process Safety standards and regulatory compliance.

Supervise a team of Production Associates

Ensure all activities are executed following quality and regulatory standards.

Promote a quality mindset and quality excellence approach to all activities.

Implement and monitor quality systems to achieve inspection readiness at all times.

Promote and drive an effective risk management process.

Participate in deviation investigations.

Ensure compliance with Data Integrity ALCOA+ principle.

Assists with production planning to achieve the departmental and site objectives.

Fully deploy performance management process within area ensuring accurate and timely data is used.

Ensure all relevant information and activities relating to production are tracked, captured, completed, and as needed, forwarded to management to include: Effective management of discretionary spend, coordination with TS to ensure equipment preventive and predictive maintenance and calibrations are appropriate and executed on schedule and in a cost-effective manner, and Manufacturing personnel coordinate, cooperate, and participate with QC in environmental monitoring and production processes.

Drive and embed the use of GSK Production System (GPS) tools and techniques to realize ever increasing levels of value from manufacturing operations.

Participate in the Validation Master Plan for production operations in partnership with the Validation team.

Drive the PQ Master Plan and manage PQ activities for area of responsibility, including development, writing, and executing, protocols and completion of final reports

Participate in identifying and assessing risks and drive continuous improvement of business processes, production documentation and training material.

Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:

Bachelor's Degree in Scientific discipline

5 or more years practical experience in a cGMP regulated environment

Minimum of 2 years of supervisory experience

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

Experience in the pharmaceutical industry

Strong interpersonal communication skills and ability to thrive in a dynamic team environment

Organizational and leadership skills with ability to effectively delegate work

Ability to prioritize and flexibility to adapt to changing business schedules and deadlines

Ability to take initiative and work proactively with creative problem-solving skills

Experience in Quality Risk Management

Root cause analysis: experience with investigation and troubleshooting

Strong technical writing skills

Influence, persuasion, and or change management

GPS, LEAN, OE, or similar continuous improvement methodologies

Ability to work in digital manufacturing environment

Position may require employees to work shifts, holidays, and weekends

Digitization and electronic work environment experience, including experience with MES, large lan uage models for improving efficiency, and application of digital tools to improving performance.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?

Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.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).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.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.