Senior Director, Regulatory Chemistry Manufacturing & Controls (CMC)

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senior director regulatory chemistry manufacturing cmc regulatory cmc manufacturing leadership health senior research
November 23, 2022
Fremont County, CO, Williamsburg
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 Organon Regulatory CMC New Products, the Senior Principal Scientist (Senior Director) Regulatory CMC New Products is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) leadership, oversight, strategy, and resource management for Organon's biosimilar products including strategic guidance and execution across development and post-approval lifecycle, 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 biosimilar programs and responsible for developing 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 oversight 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.

Lead assessment of CMC post-approval changes to define regulatory requirements and develop CMC regulatory strategies that demonstrate sound regulatory insight, a balanced approach to risk and knowledge of the changing global regulatory environment .

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 Organon's values in their day-to-day activities and serve as an example by practicing them on a daily basis.

Education Minimum Requirement : 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: Bachelors degree with at least 12 years pharmaceutical or related industry experience OR advanced degree with at least 7 years pharmaceutical or related industry experience.

Minimum 5 years working in Regulatory CMC including biosimilar/biologics experience, with progressive experience in leading global development-phase programs.

Preferred Experience and Skills: In Biosimilar/Biologics Regulatory CMC.

Strong leadership skills, as well as demonstrated understanding of related biological and/or device operations (e.g., manufacturing, process development, analytical, and quality assurance).

Demonstrate critical thinking, exceptional problem solving, strong understanding of regulatory strategies and the ability to prioritize multiple tasks .

Strong track record of development of regulatory personnel, demonstrated leadership of cross-functional activities and the ability to influence in a matrix environment .

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 .

Must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.

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.

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.

Residents of Colorado: to request this role's pay range: email: Jersey City and New York City Positions: to request this role's pay range and benefits, email:

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

For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully Organon LLC., 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: No relocation VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Flex Time, Telecommuting Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1 Requisition ID: R509490 This employer is a corporate member of myGwork - LGBTQ professionals, the business community for LGBTQ professionals, students, inclusive employers & anyone who believes in workplace equality.

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