Senior Principal Scientist (Senior Director) - Regulatory Chemistry, Manufacturing and Controls (CMC)

Job Description

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it!

Reporting to the Executive Director, Regulatory Chemistry, Manufacturing and Controls (CMC) New Products, the Senior Principal Scientist (Senior Director) Regulatory CMC New Products is responsible for Regulatory CMC leadership, oversight, strategy, and resource management for our Company's small molecule, biologic, biosimilar and/or device products including strategic guidance and execution across all phases of clinical development and global market registrations, and potential business development and licensing through due diligence assessments. The Senior Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis. The position is a fast-paced, dynamic, and impactful leadership role with direct ability to impact Organon future growth strategy & pipeline development.

Primary Responsibilities:

• Lead regulatory CMC accountability as a seasoned expert across programs and responsible for developing, influencing, and overseeing implementation of regulatory strategies and making decisions that ensure the high quality of regulatory submissions.

• Oversee a team of contributors as appropriate including providing direction to and monitoring of CMC strategy and project timelines, resource capacity analysis, management of internal and external resources to enable on-time delivery of regulatory CMC deliverables.

• Understand, interpret, and advise the technical and development teams on regulations, guidelines, procedures, and policies relating to development, registration, and manufacturing of new pharmaceutical products.

• Manage due diligence of compounds that are being evaluated through the corporate BD&L process in coordination with Regulatory CMC Franchise leadership, as appropriate. Ensure due diligence includes development of a comprehensive regulatory CMC risk assessment (e.g., regulatory risks associated with drug substance synthetic route, formulation design, analytical methods, etc.), mitigation approach, and regulatory timeline assessment that provides input into the corporate BD&L decision making business and financial evaluation for the compound.

• Partner with Research & Development, Manufacturing & Supply, Business Development, and Commercial to continually improve processes with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of product registration activities in an efficient, agile manner.

• Responsible to ensure that regulatory requirements are met and systems/processes are executed in a manner to provide visibility to accurate regulatory information to enable proper product control.

• Proactively identifies and solves complex problems or key business challenges within the Portfolio that may have significant impact to the company and identifying solutions. Responsible for timely communication of challenges and opportunities to management and help address them in a systematic and thoughtful manner.

• Demonstrated ability to anticipate and influence within and across organizations and the regulatory environment to identify potential challenges impacting the business and proactively recommend approaches to minimize regulatory risk. Represent department needs and positions in senior leadership forums.

• Demonstrated ability to be highly adaptable and establish strong cross-functional relationships with key stakeholders, customers and external organizations to ensure regulatory CMC strategies are incorporated into a broad enterprise view.

• Expected to embody our Company's values in their day-to-day activities and serve as an example by practicing them on a daily basis.

Education Minimum Requirements:

• Bachelor’s degree, in a science, engineering, or a related field.   Fields of study include:  Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry with at least 12 years of relevant experience including biological/pharmaceutical/device research, manufacturing, testing or a related field; OR

• Advanced degree (MS, MBA, Ph.D., PharmD) with at least 7 years of relevant experience including biological/pharmaceutical/device research, manufacturing, testing or a related field.

Required Experience and Skills:

• Minimum 12 years pharmaceutical or related industry experience; 7 years with an advanced degree. Minimum 5 years working in Regulatory CMC including small molecule experience, with progressive experience in leading global development-phase programs.

Preferred Experience and Skills:

• The ideal candidate will have significant direct experience in Regulatory CMC with strong leadership skills, as well as demonstrated understanding of related small molecule, biologic and/or device operations (e.g., manufacturing, process development, analytical, and quality assurance).

• The candidate must demonstrate critical thinking, exceptional problem solving, strong understanding of regulatory strategies and the ability to prioritize multiple tasks.

• The successful candidate requires a strong track record of development of regulatory personnel, demonstrated leadership of cross-functional activities and the ability to influence in a matrix environment.

• The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.

• He/she must have proven experience in CMC Regulatory Affairs and chemical/pharmaceutical development of small molecule products, including regulatory submission preparation across all stages of development from First in Human clinical trials through marketing authorization and early post-approval life cycle submissions and leading interactions with FDA and/or other global regulatory authorities.

• The candidate should be able to influence and communicate strategic direction, data assessment and risk mitigation to executive management.

• The candidate must have strong negotiation, excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.

• The candidate must be proficient in English; additional language skills are a plus.

OCMC

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

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Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

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Requisition ID:R517226