Senior Scientist External Manufacturing API and Drug Product Support

About this role

Job Description

The Position

Seeking an exceptional individual for a technical position within the Analytical Sciences – Science and Technology organization.  The successful candidate will be joining a group of innovative scientists with broad deliverables spanning activities across Active Pharmaceutical Ingredient (API) and 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 understand the technical, regulatory, and business needs for API and DP development and commercial supply, providing essential analytical support to ensure success.   A strong technical background with a superior problem-solving skill set, exceptional leadership abilities, strong knowledge of Current Good Manufacturing Practices 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.   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 Preventative 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 regulation changes to help support plans to implement new strategies.

Required Education, Experience & Skills

• BS or MS degree with at least 5 years of experience.

• PhD degree with at least 1 year of experience.

• Hands-on analytical chemistry lab experience.

• Possess practical knowledge in developing and applying analytical techniques like liquid and gas chromatography, and various spectroscopic methods to support drug substance and product development, registration, and unknown peak identification investigations.

• Experience collaborating with external service providers, proficiency in regulatory filing requirements, and ability to work effectively within cross-functional and interdisciplinary teams, demonstrating strong verbal and written communication skills.

• Demonstrate excellent interpersonal skills, adaptability, and cultural sensitivity. Skilled in tailoring communication, coaching, and collaboration to suit colleagues with diverse experience and expertise.

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

• Ability to speak up and raise issues, identify and communicate risks, and help to drive to resolution.

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

• Knowledge of drug product and/or API development and commercialization and understand the needs related to commercial quality control testing.

  Preferred Experience & Skills:

• LCMS, GCMS, NMR

• Use of statistical software for data analysis (such as Excel, Minitab)

• Basic proficiency with using internal approved AI tools

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 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. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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.

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. 

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

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