Associate Principal Scientist External Manufacturing Support-API/Drug Substance

Job DescriptionOrganon 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!THIS ROLE MAY BE 100% REMOTELY BASEDSeeking an exceptional individual for a technical leadership position within the Analytical Sciences – Science and Technology organization.  The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from Active Pharmaceutical Ingredient (API) & Drug Product (DP) to drive efficiency gains in support of global supply operations. The incumbent will be expected to interact closely with the external Contract Manufacturing Organization sites across the Manufacturing network in identifying, developing, implementing, and troubleshooting laboratory test methods, technologies and workflows as well as material for ensuring compliant, robust, and responsive supply. The individual will have a deep understanding of the technical, regulatory and business environment needs related to API (and/or DP) development and commercial supply and provide critical analytical support to ensure success.Primary R es ponsibilities :Author analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.

Perform investigations with strong technical troubleshooting skills and assist in developing/implementingCorrective Action and Preventive Actions.

Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends.

The individual will also be responsible for technical training of staff, as needed, on analytical techniques and problem solving. In addition, the incumbent will keep up with Active Pharmaceutical Ingredient regulation changes and facilitating cross company communication to influence implementation strategies.

The position will report into the Director guiding the External Manufacturing group. A strong technical background with a superior problem solving skill set, exceptional leadership abilities, strong knowledge of Current Good Manufacturing Practice and Data Integrity are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize sustained, compliant supply of products to our patients.Education Minimum Requirements:BS degree and at least 8 years of experience OR MS degree with at least 5 years experience OR PhD with at least 3 years experience in pharmaceutical development or commercial supply support for API and/or drug product

Required Experience and Skills :Have working knowledge of API and Drug Product commercial quality control testing.

Analytical development or commercial supply support for API and/or drug product.

Have a working knowledge of various analytical techniques (e.g., chromatography, dissolution, spectroscopy) and the application of specifications to support drug substance and drug product development and registration.

Have working knowledge of process by which the products are brought to and maintained on the market.

Contract Manufacturing Organizations and Clinical Research Organizations.

Have working knowledge of Capital Management Committee filing requirements.

Working with cross-functional teams.

Demonstrate strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.

Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.

Self-motivated to take ownership and accountability of issues and drive them to completion.

Ability to speak up and raise issues and help to drive to resolution.

Ability to quickly adapt to changes and develop appropriate plans for managing risks.

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: coloradopayact@organon.comUS and PR Residents OnlyIf 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 .For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementOFCCP Pay Transparency RuleOrganon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyOrganon 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:Flex Time, Remote WorkShift:Valid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R509831