Lead Biopharmaceutical Associate

Posted:
8/23/2024, 10:16:12 AM

Location(s):
Maryland, United States ⋅ Rockville, Maryland, United States

Experience Level(s):
Senior

Field(s):
Product

The Rockville Biopharm site exists to produce and deliver biopharmaceutical drug substance of the highest quality in a safe, compliant, reliable and cost-effective manner for our patients. Our vision is to be wholly entrusted to make innovative, high-quality medicines by leveraging the best talent and technology, on a platform of continuous improvement, to supply every patient, every time.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

Possesses expertise and functional knowledge of the following areas and ability to perform the activity with minimal guidance and producing quality results:

  • Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations.
  • Perform the set-up, operation, cleaning and break-down of process equipment.
  • Perform sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics.  Operate Filter integrity devices to confirm the integrity of filters pre and post use.  
  • Set-up of fixed and mobile process equipment and parts with CIP skids to carry out validated cleaning and sterilization processes. 
  • Follow appropriate standard operating procedures (SOPs), protocols and batch records to safely perform process operations and document compliantly with good documentation and data integrity practices.
  • Knowledge and skill required to manage and use automation and emerging digital platforms. 
  • Knowledge of biopharmaceutical processes and equipment to facilitate transfer of processes into Manufacturing, data analysis and identification and escalation of problems to the appropriate support group.  
  • Lead in the application of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors in problem solving.
  • Knowledge and experience with process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments.
  • Assist resolution of technical and process problems; Identify, develop and implement process. 
  • A key management capability that encompasses the ability to collaborate and build relationships to define the organizational and business big picture (mission, vision, strategic plan, etc.).
  • Build positive relationships with others and conduct negotiation to establish win/win solutions.
  • Ability to choose a type of communication that is most effective in a given situation. Such competency empowers individuals to achieve the goals of any communication in a manner that is best suited for all parties involved.
  • Ability to articulate production equipment and / or manufacturing process problems to ensure accurate and detailed communication.
  • Transfers information to audiences of varying levels of technical knowledge, so that each member of the audience clearly understands the message.
  • The ability to provide strong teaching and facilitation skills in training delivery.
  • Follow all related safety policies and procedures and put safety first by playing an active role in identifying and correcting unsafe behaviors and conditions.

Basic understanding and knowledge of the following areas and ability to perform the activity with some supervisory guidance:

  • Ability to explain and utilize techniques to improve and sustain physical energy levels through the day to support resilience on teams. 
  • Working with others to gain win-win situations, using persuasive communication, understanding influencing models, negotiation, overcoming resistance.
  • Review all appropriate production documentation and ensure GMP compliance and metric attainment.

General familiarity with the following areas:

  • Developing team capability to learn with knowledge of coaching styles, listening and questioning techniques, feedback models and emotional intelligence.
  • An appreciation of cultural differences and diversity in the workplace.
  • General knowledge of Microsoft Office Applications (Excel, Word, and Outlook).

Why you?

Basic Qualifications:

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

  • High School Diploma or equivalency
  • 5+ years of directly related manufacturing experience in the pharmaceutical or biotechnology industry
  • Ability to work shifts that cover a 24/7 production operation
  • Ability to lift and carry materials weighing as much as 50lbs.

Preferred Qualifications:

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

  • Bachelor of Science / Bachelor of Art / Associates Degree in biological sciences, chemical sciences, engineering or equivalent technical discipline.
  • Strong verbal and written skills. 
  • Demonstration of a high level of performance
  • Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation

#LI-GSK

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).

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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Glaxosmithkline Plc

Website: https://gsk.com/

Headquarter Location: London, England, United Kingdom

Employee Count: 10001+

Year Founded: 1929

IPO Status: Public

Last Funding Type: Grant

Industries: Biotechnology ⋅ Health Care ⋅ Pharmaceutical