Production Manager

Site Name: USA - Maryland - Rockville Posted Date: Sep 23 2021 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, functional knowledge and experience, the ability to perform the activity without guidance and teach others in the following areas: Knowledge of biopharmaceutical processes and equipment to facilitate transfer of processes into production, 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. Transfers information to audiences of varying levels of technical knowledge, so that each member of the audience clearly understands the message. Working with others to gain a win-win situation, using persuasive communication, understanding influencing models, negotiation, overcoming resistance. 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. Ability to explain and utilize techniques to improve and sustain physical energy levels through the day to support resilience on teams. Developing team capability to learn with knowledge of coaching styles, listening and questioning techniques, feedback models and emotional intelligence. Review all appropriate production documentation and insure GMP compliance and metric attainment. Possesses expertise and functional knowledge of the following areas and ability to perform the activity without 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 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 design tests and establish documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products Knowledge and application of standard ERP processes in M-ERP following global and local procedures Comprehensive review of an organization or departments adherence to regulatory guidelines and global corporate and local procedures. A key management capability for mid to upper level management that encompasses the ability to collaborate and build relationships to define the organizational and business big picture (mission, vision, strategic plan, etc.), anticipate the future and external environment (competition, market, demand, etc.) and take strategic action to establish a competitive edge and organizational success The ability to provide strong teaching and facilitation skills in training delivery to engage an audience to ensure that high impact learning outcomes are reached. 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. Basic understanding and knowledge of the following areas and ability to perform the activity with some supervisory guidance: An appreciation of cultural differences and diversity in the workplace. Build positive relationships with others and conduct negotiation to establish win/win solutions. Recruit, hire and maintain appropriate staff levels to meet operational and strategic goals. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor of Science / Bachelor of Art in biological sciences, chemical sciences, engineering or equivalent technical discipline. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience. 7+ years of directly related experience manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance and 2 years of supervisory experience Experience of the basic Federal Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations. Strong verbal and written skills Must be able to follow detailed processing instructions as well as accurately documenting any necessary information Demonstrated ability to work effectively in a team Required to work various and/or rotating shift structures that may cover 24/7/365 operations" Ability to lift and carry materials up to 50 lbs 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 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). 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