Senior Scientist, Chemistry

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. …