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Lead Biopharmaceutical Associate

Rockville, MD
Closing date
Jul 28, 2021

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Life Sciences, Biochemistry
Organization Type
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Are you looking the opportunity to be with a company that manufactures products that treat challenging diseases such as Lupus, severe Asthma, and Cancer? Do you want to be part of a team that is committed to helping people do more, feel better, and live longer. If so, this opportunity at GSK for a Lead Biopharmaceutical Associate may be the role for you. As a Lead Biopharmaceutical Manufacturing Associate you will be under the direction of senior personnel and perform production operations including fermentation or cell culture operations, prepare media and buffer solutions, chromatographic separation, filtration and concentration operation, as well as being involved in both start-up and product changeover activities. 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: Transfers information to audiences of varying levels of technical knowledge, so that each member of the audience clearly understands the message. Lead in the application of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors in problem solving. Set-up of fixed and mobile process equipment and parts with CIP skids to carry out validated cleaning and sterilization processes. 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. 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. 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. 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.), Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations. 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. 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. Knowledge of biopharm processes and equipment to facilitate transfer of processes into Manufacturing, data analysis and identification and escalation of problems to the appropriate support group. Ability to articulate production equipment and / or manufacturing process problems to ensure accurate and detailed communication. Build positive relationships with others and conduct negotiation to establish win/win solutions. The ability to provide strong teaching and facilitation skills in training delivery. Follow all safety related policies and procedures. Assist resolution of technical and process problems; Identify, develop and implement process. 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 a win win situation, using persuasive communication, understanding influencing models, negotiation, overcoming resistance Review all appropriate production documentation and insure 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) CLICK HERE TO LISTEN TO A MESSAGE FROM THE MANAGER 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 experience manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance Understanding the of the basic Federal Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations; Must exhibit GSK Values and Expectations Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation. Ability to work shift that covers a 24/7 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 Why GSK? 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 *LI-GSK GSKBiopharm_manufacturing 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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