Regulatory CMC, Associate Principal Scientist Product Lead (Multiple Openings)

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Lansdale, Pennsylvania

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Tue, 15 Dec 2020 23:59:59 GMT

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Job Details Full-timeEstimated: $99,000 – $120,000 a year1 hour ago Benefits – Health insurance Qualifications – Leadership – Communication skills – Chemistry, manufacturing & controls – Negotiation – Manufacturing – Bachelor’s degree Full Job Description Job Description Position Description: Reporting to the Director or Executive Director in our company’s Regulatory CMC, the Associate Principal Scientist is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations and guidance’s, and company procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations and post-approval changes. The incumbent may manage a team of 1 to 2 individual contributors and/or outsourcing partners in support of project execution. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis. Regulatory Responsibilities: Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal. Collaborate with our company’s Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Demonstrate an understanding of regulatory affairs and this understanding to the benefit of the company to ensure approval and Product supply continuity. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as needed Education Minimum Requirement: B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Required Experience and Skills: A minimum of five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields. The candidate must be proficient in English; itional language skills are a plus. Technical Skills: Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Leadership Skills: Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, interpersonal and negotiating skills. Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines. Preferred Experience and Skills: A candidate with experience in Regulatory CMC post-approval lifecycle management is preferred #Newco Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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. 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 toing 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 Show full job description Apply Now