Senior Scientist, Chemistry

Organon LLC; Lower Gwynedd Township (PA); On-site; USD 103,000 - 175,000; Full time

Benefits offered by this job

Flexible work arrangements

Job summary

Organon, a global health company, seeks a technical leader for the Analytical Sciences laboratory in Lower Gwynedd, PA. The role focuses on API/DP analytical tech transfer, method development, troubleshooting, and continuous improvement across manufacturing and release sites.

You will interact with internal manufacturing networks, validate and implement analytical workflows, and drive regulatory-ready technical documentation to support drug product development and commercialization.

Qualifications

• Ph.D. in Analytical Chemistry or related field with 0–3+ years of pharma experience, or MS with 3+ years API/DP experience, or BS with 7+ years API/DP experience.
• Experience developing/validating/troubleshooting analytical methods (e.g., chromatography, dissolution, spectroscopy).
• Strong communication and collaboration in interdisciplinary teams.
• Demonstrated ownership, accountability and risk management.
• Familiarity with GMP, quality, data integrity preferred.

Responsibilities

• Execute method development, validation and transfer activities.
• Analyze data, report statistics, and identify trends and root causes.
• Prepare procedures, reports and regulatory submission documents.
• Support investigations and CAPAs with technical input.
• Assist audits and inspections with documentation and input.
• Interpret data to aid problem resolution and decision making.

Skills

Analytical method development

Data analysis

Interdisciplinary teamwork

Troubleshooting

Regulatory documentation

Education

Ph.D. in Analytical Chemistry

MS in Chemistry/Pharma

BS in Chemistry/Pharma

Tools

Empower

Chromatography

Spectroscopy

NMR

Job description

Job Description

The Position We are currently seeking an exceptional colleague for a technical leadership position within the Analytical Sciences (AS) laboratory within Science and Technology at the Lower Gwynedd, Pennsylvania location. The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from Active Pharmaceutical Ingredient (API) and Drug Product (DP) analytical technology transfer and troubleshooting to driving lead time reduction and efficiency gains at our commercial manufacturing and release sites. The colleague will be expected to interact closely with the internal sites in the manufacturing network in identifying, developing, validating, implementing, and troubleshooting laboratory test methods, technologies and workflows as well as material for ensuring compliant, robust, and responsive product supply. She or he will deepen understanding of the technical, regulatory and business environment needs related to drug product development and commercialization, drug product (DP) commercial supply, stability testing and provide critical analytical support to ensure our company's success. The position will report to the Director of the Analytical Sciences laboratory located at Spring House Innovation Park (SHIP) in Lower Gwynedd, PA. A strong technical background with a superior problem-solving skill set is considered essential, as these will be key attributes necessary to facilitate the ability to influence efforts to realize our company goals.

Responsibilities

• Execute analytical method development, improvement, validation and/or transfer activities
• Analyses and interprets data to report statistical results, make informed decisions, visualize and understand trends, discover root causes, etc.
• Author and/or execute analytical procedures and/or methods development and validation protocols, technical reports, experimental designs, regulatory submission documents, etc.
• Assist or perform investigations with strong technical troubleshooting skills and assist in developing/implementing corrective and preventive actions (CAPAs)
• Provide documentation and technical input during inspections and audits (Regulatory and Internal)
• Perform data analysis and interpretation to support problem resolution and decision making

Required Education, Experience & Skills

• Ph.D. degree in Analytical Chemistry or related discipline with 0-3+ years relevant work experience or;
• MS degree with 3+ years of pharmaceutical experience API and/or drug product.
• BS 7+ pharmaceutical experience API and/or drug product
• Working knowledge of developing and/or validating and/or troubleshooting analytical techniques (e.g., chromatography, dissolution, spectroscopy).
• Hands on analytical laboratory experience
• Demonstrated strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment.
• Demonstrated strong interpersonal skills with flexibility and sensitivity in dealing with different cultures
• Demonstrated self-motivation 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.

Preferred Experience & Skills

• Working knowledge of lab GMP, quality, compliance and data integrity requirements and related recent industry trends
• Working knowledge of chromatographic techniques and/or mass spectrometry and/or NMR
• Working knowledge chromatographic acquisition systems, e.g., Empower
• Working knowledge of API and DP characterization techniques, e.g., dissolution, water activity, particle size distribution and/or other test methodologies
• Working knowledge of API and/or Drug Product development and commercialization and understanding the needs related to commercial quality control.
• Working knowledge of statistics and tools, e.g. design of experiments and/or statistical data treatment and/or Minitab
• Working knowledge of process by which the products are brought to market with an understanding of the roles and responsibilities of the related functional organizations within our manufacturing and research divisions.
• Working knowledge of product specifications to support drug development and registration.
• Working knowledge of Chemistry Manufacturing & Control (CMC) filing requirements.
• Experience working with Contract Manufacturing Organization (CMO)’s and Contract Research Organization (CRO)’s
• Experience identifying, implementing and/or sustaining new lab technologies such as automation, rapid tests, etc.

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.

Equal Employment Opportunity

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, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US) $103,100.00 - $175,300.00

Please Note: Pay Ranges are Specific to local market and therefore vary from country to country

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship:

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

10% Flexible Work Arrangements: Work Week Shift: Valid Driving License: Hazardous Material(s): Work in the laboratory with common reagents such as solvents and salts.

Number of Openings: 1

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.