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.  The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from Active Pharmaceutical Ingredient (API) and Drug Product 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 have a deep understanding of the technical, regulatory and business environment needs related to drug product development/commercialization, drug product commercial supply, stability testing and provide critical analytical support to ensure our company's success.

The position will report into the Director of the Analytical Sciences laboratory located at Spring House Innovation Park (SHIP) in Lower Gwynedd, Pennsylvania.  A strong technical background, primarily with small molecules, and 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's 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 CAPAs.

Provide documentation/technical input during inspections and audits (Regulatory and Internal).

Perform data analysis and interpretation to support problem resolution and decision making.

Required Education, Experience and 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 degree with 7+ years pharmaceutical experience API and/or drug product.

Working knowledge of developing and/or validating and/or troubleshooting analytical techniques (e.g., chromatography, dissolution, spectroscopy).

Working knowledge of chromatographic acquisition systems, e.g., Empower.

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 and Skills

Working knowledge of lab GMP, quality, compliance and data integrity requirements and related recent industry trends.

Working knowledge of Empower.

Working knowledge of water activity and other moisture test methodologies.

Working knowledge of API and/or Drug Product development and commercialization and understand 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 specification 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:

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EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants 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:

No

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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R531700