Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Controls (CMC) - Biosimilars

Job Description

The Position

The successful candidate will collaborate with internal cross-functional project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes oversight of assets in various phases of development through registration and post-launch, along with supporting business development due diligence activities.

Responsibilities

• Provide global strategic regulatory CMC overview for respective products and portfolio.
• Serve as the regulatory CMC point of contact for alliance partners and health agencies, as defined by specific deal agreements.
• Collaborate with alliance management and relevant functions to integrate new assets into Organon and lead regulatory sub-teams in both strategic and operational aspects of integration work.
• Guide internal R&D stakeholders and teams, along with alliance partners and commercial teams, in creating and implementing global regulatory CMC strategies for the registration, maintenance, and global market expansion of biosimilar products.
• Lead the development and implementation of global regulatory strategies by assessing CMC changes, identifying regulatory requirements, and evaluating documentation to confirm acceptability and potential risks.
• Execute regulatory strategies by developing, authoring, and reviewing CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions.
• Provide regulatory leadership for product in-licensing, due diligence reviews, product divestment, and withdrawals.
• Collaborate with Organon Manufacturing & Supply colleagues and external partners to ensure compliance execution of change management with a focus on regulatory conformance.
• Manage the preparation and execution of CMC documentation for post-approval supplement, annual reports, registration renewals, and responses to health authority questions.
• Participate in projects and initiatives beyond current responsibilities as needed to drive organizational success.
• Provide solutions and manage day-to-day operational issues outside of current responsibilities when needed.

Required Education, Experience, and Skills

• 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 seven years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR
• Advanced degree (MS, MBA, Ph.D., PharmD) with at least four years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.
• At least one year of direct experience in Regulatory CMC with demonstrated understanding of related pharmaceutical, biological or device operations (e.g., manufacturing, process development, analytical, and quality assurance) is required.
• At least five years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields.
• The candidate must be proficient in English; additional 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.

Secondary Language(s) Job Description

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.

US and PR Residents Only

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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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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.

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.

Annualized Salary Range (US)

$125,400.00 - $213,100.00

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%

Flexible Work Arrangements:
Flex Time, Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1