Associate Principal Scientist External Manufacturing Support-Api/Drug Substance

Organon & Co North Wales , PA 19454

Posted 2 weeks ago

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!

THIS ROLE MAY BE 100% REMOTELY BASED

Seeking 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.

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.

Primary Responsibilities:

  • 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/implementing Corrective 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.

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.

Secondary Language(s) Job Description

Organon est une entreprise de sant des femmes qui croit en une meilleure sant pour chaque femme, chaque jour! Nous sommes une communaut internationale de milliers de personnes passionnes qui se consacrent redfinir l'avenir de la sant des femmes. Notre mission consiste offrir des mdicaments et des solutions efficaces pour une meilleure sant au quotidien. Mais ce qui fait vraiment fonctionner Organon, ce sont les membres de notre personnel.

Nous sommes la recherche de vrais joueurs d'quipe passionns, d'innovateurs curieux, de penseurs avant-gardistes, motivs par l'ide de faonner leur carrire et prts passer l'action pour accueillir le changement et les occasions de progrs qu'il apporte.

Chez Organon, vous profiterez du meilleur des deux mondes : la culture ouverte, agile et collaborative d'une entreprise en dmarrage, et l'envergure d'une entreprise du Fortune 500, qui a une prsence internationale et sert les gens sur plus de 140 marchs.

Ce sera un avenir prometteur - venez y participer!

Scientifique associ(e) principal(e) en soutien au groupe Fabrication externe d'IPA/substance pharmaceutique

CE POSTE PEUT TRE ENTIREMENT EN TLTRAVAIL.

Nous sommes la recherche d'une personne exceptionnelle pour occuper un rle de leadership technique au sein de l'quipe Sciences analytiques

  • Sciences et technologie.

Le candidat retenu se joindra un groupe de scientifiques novateurs responsable de nombreux livrables, qu'il s'agisse d'ingrdients pharmaceutiques actifs (IPA) et de produits mdicamenteux (PM) ou de gains d'efficience visant l'amlioration des oprations d'approvisionnement mondiales. Le titulaire du poste devra collaborer troitement avec les sites externes d'organismes de fabrication sous contrat dans l'ensemble du rseau de fabrication pour dterminer, mettre au point et mettre en uvre des mthodes d'analyses de laboratoire, des technologies, des flux de travail et du matriel, et trouver des solutions en cas problme, pour assurer un approvisionnement conforme, robuste et ractif. La personne retenue aura une comprhension approfondie des besoins lis l'environnement technique, rglementaire et commercial au chapitre de la mise au point et de l'approvisionnement commercial des IPA (et/ou des PM), et fournira un soutien analytique essentiel pour assurer la russite de l'entreprise.

Le titulaire relvera du directeur du groupe Fabrication externe. Il doit essentiellement possder un solide bagage technique assorti d'un ensemble de comptences suprieures en matire de rsolution de problmes, des capacits de leadership exceptionnelles, une connaissance approfondie des bonnes pratiques de fabrication les plus rcentes et de l'intgrit des donnes, car il s'agit d'attributs indispensables qui lui donnera la capacit d'influencer le changement dans le but d'assurer nos patients un approvisionnement durable et conforme en produits.

Principales responsabilits

  • Rdiger des procdures analytiques, des protocoles et des rapports de dveloppement et de validation de mthodes, des rapports techniques, des plans exprimentaux, des documents de soumission rglementaire, etc.

  • Effectuer des vrifications avec de solides comptences en matire de dpannage technique et contribuer l'laboration et la mise en uvre d'actions prventives et d'actions correctrices.

  • Fournir de la documentation et des donnes techniques dans le cadre d'inspections et d'audits (rglementaires et internes) et dtenir une connaissance pratique de l'intgrit des donnes et des tendances rcentes du secteur.

  • La personne retenue sera galement responsable de la formation technique du personnel, selon les besoins, sur les techniques d'analyse et la rsolution de problmes. De plus, le titulaire se tiendra au courant des changements apports la rglementation sur les ingrdients pharmaceutiques actifs et facilitera la communication entre les entreprises pour influer sur les stratgies de mise en uvre.

Exigences de scolarit minimales

  • Baccalaurat avec un minimum de 8 ans d'exprience OU matrise avec un minimum de 5 ans d'exprience OU doctorat avec un minimum de 3 ans d'exprience dans la mise au point de produits pharmaceutiques ou le soutien l'approvisionnement commercial pour les IPA et/ou les produits mdicamenteux.

Exprience et comptences requises

  • Dtenir une connaissance pratique des tests de contrle de la qualit commerciale des IPA et des produits mdicamenteux.

  • Dveloppement analytique ou soutien l'approvisionnement commercial pour les IPA et les produits mdicamenteux.

  • Possder une connaissance pratique de diverses techniques d'analyse (p. ex., chromatographie, dissolution, spectroscopie) et de l'application des spcifications pour soutenir l'laboration et l'inscription de substances et de produits mdicamenteux.

  • Avoir une connaissance pratique du processus par lequel les produits sont mis et maintenus sur le march.

  • Organismes de fabrication sous contrat et organisme de recherche en mdecine clinique.

  • Dtenir une connaissance pratique des exigences de dpt du Comit de gestion du capital.

  • Travailler avec des quipes interfonctionnelles.

  • Dmontrer de solides comptences en communication orale et crite et tre capable de travailler dans un contexte d'quipe interdisciplinaire.

  • Faire preuve de solides aptitudes interpersonnelles, de souplesse et de sensibilit face des cultures diffrentes.

  • Volont d'assumer la responsabilit des problmes et de les mener bien.

  • Capacit de s'exprimer pour soulever des problmes et de contribuer leur rsolution.

  • Capacit de s'adapter rapidement aux changements et d'laborer des plans appropris de gestion des risques.

Qui nous sommes :

Organon propose des solutions de sant ingnieuses qui permettent aux gens de profiter de la vie au maximum. Notre entreprise mondiale du secteur des soins de sant gnre un chiffre d'affaires de 6,5 milliards de dollars et s'engage faire toute la diffrence pour les femmes, leurs familles et les communauts dont elles s'occupent. Nous dveloppons notre importante gamme de produits importante en investissant dans les besoins non satisfaits lis la sant des femmes, en donnant accs aux principaux produits biosimilaires et en touchant des vies grce une gamme diversifie de solutions de sant fiables. Notre vision est claire : Chaque jour, une meilleure sant pour chaque femme.

Aux reprsentants des agences de recrutement, veuillez lire attentivement :

Organon LLC n'accepte aucune aide non sollicite des agences de recrutement l'gard des possibilits d'emploi. Tous les curriculum vit soumis par des agences de recrutements un employ de notre socit sans la conclusion pralable d'un accord de recrutement crit valide pour ce poste seront considrs comme la proprit exclusive de notre socit. Aucun honoraire ne sera vers si un candidat est embauch par notre entreprise la suite d'une recommandation d'une agence avec laquelle aucune entente prexistante n'est en place. Lorsque des ententes d'agence sont en place, les prsentations sont propres au poste. Veuillez ne pas appeler ni envoyer de courriels.

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.com

Jersey City and New York City Positions: to request this role's pay range and benefits, email: jcnycpay@organon.com

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.

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:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Flex Time, Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R509831

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Associate Principal Scientist External Manufacturing Support-Api/Drug Substance

Organon & Co