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Gwynedd, Pennsylvania

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Sun, 13 Dec 2020 23:59:59 GMT

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Job Description This position is within the BVA Outsourcing Oversight and Technical Core and will influence late stage development, validation, transfers and life-cycle management of methods supporting our Company’s and biologics pipeline and inline products. Specific job responsibilities include analytical subcontract management, progress reporting, technical troubleshooting, project management, analytical development and optimization, and commercial life-cycle management of analytical strategy for vaccines and biologics. Responsibilities – Regular communication, oversight and collaboration with external contract research organizations (CRO) for outsourced analytical methods, to monitor timelines and deliverables – Collaborate with contract labs on initiation, execution, and delivery of method development, validation and sample test results – Communicate with departmental subject matter experts to solve technical and nontechnical challenges throughout the life of the analytical project – Interact closely with Procurement and Quality functions to ensure compliant outsourcing contracts are maintained and processes are standardized across the department – Collaborate with Regulatory teams to support product registrations, launches, and troubleshooting activities, including documentation preparation, when the programs include outsourced components – Monitor performance and report timeline updates, pricing adjustments or overall project changes – Support analytical compliance and Quality for investigations and corrective actions – Manage analytical transfers to or from CRO facilities – Manage outsourced testing related SOP updates – Ensure project results meet requirements regarding technical quality, reliability, schedule and cost – Project management and project forecasting – Monitor purchase orders and invoices for outsourced programs – Initiate stakeholder feedback for CRO projects, update scorecards and complete after-action reviews Education Minimum Requirement Position Qualifications: – M.S. in the biological sciences with 1+ year of experience in academia or industry, OR – B.S. in the biological sciences with 3+ years of experience in academia or industry. Required Experience And Skills – Capability to manage individual components of a project and prioritize well – Proven organizational skills, good communication and problem-solving ability – Good technical, communication (oral and written), interpersonal, and teamwork skills – Self-motivated with a positive attitude and proven performance record – Experience working in a cGMP environment – Experience with or exposure to one or more of the following analytical techniques: Bioassay, Viral Infectivity assays (plaque/TCID50/others), Plaque assay, ELISA methods, PCR/RT-PCR, Sequencing, Separations methods (e.g. HPLC/UPLC), CE Preferred Experience And Skills – Experience working with contract research organizations and/or procurement teams – Ability to work independently and work within a cross-functional team – Assay validation and transfer experience – Experience with continuous improvement or Project Management Professional certification Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. Who We Are . We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development. What We Look For . In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth. INVENT. IMPACT. INSPIRE. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. US And Puerto Rico Residents Only If you need an accommodation for the application process please email us at For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation: Domestic VISA Sponsorship No Travel Requirements Flexible Work Arrangements: Shift Valid Driving License: Number Of Openings Hazardous Material(s): 1 Requisition ID:R79985