Senior Scientist, Chemistry
Organon
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Job summary
Organon in Lower Gwynedd, PA, is seeking a technical leader for the Analytical Sciences laboratory. The role focuses on API/DP analytical technology transfer, troubleshooting, and efficiency improvements across manufacturing and release sites.
The candidate will interact with manufacturing networks to develop, validate, implement, and troubleshoot test methods and workflows while ensuring compliant, robust product supply.
Qualifications
- Ph.D. or MS with relevant pharmaceutical analytics experience.
- Hands-on experience with analytical method development, validation or transfer.
- Strong communication and collaborative skills.
Responsibilities
- Lead analytical method development, validation or transfer projects.
- Interpret data, report results, identify root causes and trends.
- Prepare technical reports, regulatory submissions and CAPAs.
- Support inspections and audits with technical input.
- Collaborate across sites to enable compliant drug product testing.
- Drive continuous improvement and lead troubleshooting.
Skills
Education
Tools
Job description
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.
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.
- 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
- 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.
- 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.
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.
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.
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.
$103,100.00 - $175,300.00
Regular
No relocation
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%
Work Week
Work in the laboratory with common reagents such as solvents and salts.
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