Associate Director, Biologics Regulatory Chemistry, Manufacturing and Controls
Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Under direction from Director/Executive Director, the Associate Principle Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Associate Principle Scientist is responsible for the preparation and submission of CMC sections for commercial or new biologics products. The Associate Principle Scientist will assist in the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Senior Scientist/Scientist in support of their assigned projects.
- Participation in the authorization process to prioritize submissions.
- In depth knowledge of global CMC guidelines regarding Investigational New Drug (IND)/Biologics Licensing Agreements (BLAs) or post approval changes.
- Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
- Development and execution of detailed, global regulatory strategies for submission and approval of INDs, BLAs or post approval change documentation according to defined timelines.
- Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
- Lead authoring of clear, concise and effective IND/ Clinical Trial Applications (CTAs), BLAs or global post approval submissions according to defined timelines.
- Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
- Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
- Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed.
Education Minimum Requirements
- B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry or Biochemistry.
Required Experience And Skills
- A minimum 5 years of Industrial/regulatory experience in biologics research, development and/or manufacturing.
- Prior Biologics IND, License Application (BLA) and/or post approval filing experience or 10 years subject matter expertise in CMC development or manufacturing.
- Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are 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.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
Preferred Experience And Skills
- At least seven (7) years of experience in support of biologics.
- Experience with IND, BLA or post approval changes in Biologics or Vaccines.
- Preferred fields of study include Microbiology, Virology, Molecular Biology, Engineering or Biochemistry.
We are a research driven bio-pharmaceutical company. Our mission is built on the simple premise that if we follow the science and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who We Are .
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as Merck in the United States, Canada & Puerto Rico. We are known as MSD in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
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.
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.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
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