Senior Scientist, Site CMC - Oss Pharma

Job Description

Organon is hiring a Senior Scientist for Site CMC. This role is part of the Organon Regulatory CMC organization and involves supporting Site CMC activities at the designated manufacturing site. Reporting to the Associate Director Site CMC, the Senior Scientist will support CMC conformance programs for Organon products to ensure that Organon products are manufactured, tested and released in accordance with the approved Marketing Authorizations. This includes providing support for product change control development, assessment of change control requests from the Organon Manufacturing & Supply (OMS) sites, representing Regulatory CMC on Site Change Review Boards, providing regulatory CMC input into inquiries and working with headquarters CMC teams to facilitate preparation of global regulatory CMC submissions.

The working hours for this role can be either 32 or 40 hours per week.

Role Responsibilities:

• Core function – manage the interface between the Manufacturing Site and Regulatory CMC to maintain product regulatory conformance. Specific responsibilities include:

• Ensuring that regulatory-impacting changes are correctly identified and assessed for regulatory impact. Work with other CMC teams to ensure that regulatory post-approval changes are managed & processed efficiently through to last market approval and implementation.

• Working with Site Quality, Technical and Supply Chain functions to provide regulatory submission status, when requested to ensure that product released to a market complies to the relevant Marketing Authorization.

• Act as a point of escalation for regulatory compliance or related issues that may arise at the manufacturing site and serve as a Subject Matter Expert in the management and resolution of any such issues.

• Represent the CMC organization and provide regulatory input to Site teams/ committees, including Change Review Boards, Quality Councils, product and investigation teams.

• Ensuring that the information included in global regulatory submissions/filings is aligned to plant information and supports future compliance and maintenance.

• Ensuring that regulatory information is correctly maintained, updated, and interpreted in Regulatory Information systems and tools.

• Coordinate submission component authoring (mainly for post-approval CMC changes) with site subject matter experts and CMC product leads.

• Support product teams to coordinate responses to Health Authority (HA) questions on submissions impacting manufacturing sites.

• Obtain site technical data, reports, and ancillary documents to support regulatory CMC submissions and response to Health Authority questions.

• Participate in major project teams where there will be significant regulatory CMC impact, e.g. product transfer teams, new product introductions, etc.

• Support Health Authority notifiable events and site investigations.

• Support Healthy Authority inspections of the manufacturing site.

Required Education, Experience, and Skills

• Bachelor’s degree (e.g., Bachelor of Applied Science or Bachelor of Science) or higher in fields such as pharmacy, chemistry, biotechnology, microbiology, or biomedical sciences. A minimum of 3 years of experience in the pharmaceutical industry in regulatory, compliance, technical services, or quality roles is required.

• The ideal candidate will have at least 1-2 years of experience in CMC Regulatory Affairs for pharmaceutical or biotechnology products.

• The candidate should have a solid understanding of and experience in a busy commercial manufacturing environment. They must be able to effectively manage the competing demands of site and corporate stakeholders.

• The successful candidate will demonstrate strong problem-solving skills, attention to detail, and the ability to prioritize multiple tasks.

• Excellent interpersonal skills and proven ability to communicate effectively in both written and verbal formats are essential.

• Proficiency in English is required; additional language skills are advantageous.

• The candidate must be able to influence and work both independently and collaboratively within a team structure.

• The ability to work well under pressure is essential.

Secondary 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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

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.

Annualized Salary Range

Annualized Salary Range (Global)

65.900,00 - 112.000,00 EUR Annual

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R534201