Associate Scientist/Senior Scientist- Downstream Biopharm Manufacturing
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Sep 10 2021 The Associate Scientist assists the manufacture of clinical supply of investigational biopharmaceutical molecules. Specifically, hands-on cGMP manufacture of mid to large scale purification of bulk drug substance for use in early phase clinical trials. The key responsibilities of the role include the following: Performs hands-on processing of large-scale purification steps under cGMP regulatory conditions. Processing steps include: Column packing, Chromatography, UltraFiltration/DiaFiltration, Depth Filtration, Bulk Drug Fill Executes and overseas production of clinical supplies based on established scientific procedures and protocols and implements improvements with minimal supervision; interprets data and draws conclusions from the data Completes activities requiring independent thought that have the potential to comprise 50-100% of the employee's time depending on production campaigns Supports the technology transfer process through active participation in ensuring that new processes fit and execute consistently Performs cleaning/sanitization of equipment and associated parts utilizing equipment washers, Clean-In-Place (CIP) systems as well as manual cleaning methods Prepares, assembles and sterilizes via autoclave of equipment and process components Prepares buffers, including weigh and dispense, formulation, and filtration activities In addition to manufacturing responsibilities, works on projects and assignments where independent action and a high degree of initiative are required in order to resolve problems and make recommendations This role will provide YOU the opportunity to lead key activities to progress YOUR career. The responsibilities of the role include the following: Leads or works on projects and assignments where independent action and a high degree of initiative and knowledge are required for execution or to provide recommendations Anticipates/recognizes potential problems with equipment and/or supplies, and proactively seeks input from other Scientists to take action to solve or prevent problems Represent the group during cross-functional initiatives Serve as Subject Matter Expert (SME) Train and mentor less experienced manufacturing scientists Recognizes potential safety and compliance problems and takes action to rectify Troubleshoots problems in the execution of processing activities; proactively assesses options and impact and takes action to rectify or communicate to appropriate decision makers Authors Standard Operating Procedures (SOPs), Safety Assessments, and various other protocols with minimal supervision Reviews and approves executed documentation, Buffer Forms, and/or Batch Records prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices Leads deviation investigations and implementation of CAPAs stemming from Safety or Compliance observations Identifies process improvement opportunities with impact on safety, compliance, and efficiency/cost Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree Chemical Engineering, Biology, Chemistry, or other engineering or scientific field OR 2+ years of equivalent experience. Must be available to work off-shift hours: early mornings, late evenings/nights, and weekends if necessary Preferred Qualifications: If you have the following characteristics, it would be a plus: Bachelor degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field with 3+ year(s) of direct GMP manufacturing experience or purification experience Experience in a Good Manufacturing Practices (GMP) environment Possess in-depth knowledge of how to analyze and interpret experimental/process data Thorough knowledge of routine laboratory/plant equipment and demonstrates high level of technical expertise with working familiarity with a number of methods, techniques, laboratory procedures and processes Experience with GE platform of purification equipment and Unicorn software Large-scale downstream manufacturing experience Thorough knowledge of routine laboratory/plant equipment and demonstrates high level of technical expertise with working familiarity with a number of methods, techniques, laboratory procedures and processes Demonstrates good interpersonal skills, and communicates well both verbally and through written communications. Maintains a professional and productive relationship with area management and co-workers Ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment 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. 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. 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