Biopharmaceutical Associate, Senior

Site Name: USA - Maryland - Rockville Posted Date: Sep 23 2021 Job Description 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. Ability to choose a type of communication that is most effective in a given situation. Transfers information to audiences of varying levels of technical knowledge, so that each member of the audience clearly understands the message. 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 articulate production equipment and / or manufacturing process problems to ensure accurate and detailed communication. Actively participating in the application of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors. Working with others to gain win-win situations, using persuasive communication, understanding influencing models, negotiation, overcoming resistance. General familiarity with the following areas: 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. 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.), General knowledge of Microsoft Office Applications (Excel, Word, and Outlook). Actively participating in the application of the GSK Production System (GPS) continuous improvement system and apply the GPS mindsets and behaviors. Working with others to gain win-win situations, using persuasive communication, understanding influencing models, negotiation, overcoming resistance. General familiarity with the following areas: 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. 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.), 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 3+ years of directly related experience manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance Experience of the basic Federal Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations Required to work various and/or rotating shift structures that may cover 24/7/365 operations 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. 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritization, execution, delivering performance. Setting strategic direction and leading on-going organizational transformation. Building a resilient organization. Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit. Managing P&L and capital allocation. *LI-GSK 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.