Job Description

The Position

Responsibilities

Under supervision and/or independently execute analytical method development, improvement, validation and/or transfer activities from our laboratory in Springhouse, Pennsylvania.

Execute analytical procedures and/or method development/improvement/remediation and validation protocols. Contribute to write up of protocols, experimental designs, technical protocols and regulatory submission documents, etc.

Perform data analysis/graphing and interpretation to support problem resolution and drive informed data-driven decision making.

Assist on investigations with strong technical troubleshooting skills and assist in developing/implementing corrective and preventive actions (CAPAs).

Work independently and/or in collaboration with multiple stakeholders, managing multiple projects and duties within the functional group/laboratory and Company’s manufacturing groups.

Responsible for following safety rules and maintaining a safe, orderly, compliant environment in the laboratory

Assist with laboratory operations, e.g., safety procedures and practices, lab inspections, lab supply inventory, etc.

Required Education, Experience and Skills

MS degree with 3+ years of pharmaceutical experience in API and/or drug product.

BS degree with 5+ pharmaceutical experience in API and/or drug product.

Working knowledge of developing and/or validating and/or troubleshooting analytical methods for small molecules (e.g., chromatography, dissolution, spectroscopy, etc.).

Extensive testing experience in the pharmaceutical industry with solid dose, liquids, suspensions, topical OTCs and prescription drugs.

Ability work independently and hands on in the lab.

Hands on experience with chromatographic integration and with Empower software (or other chromatographic data acquisition systems).

Familiarity with API and/or Drug Product development and commercialization and understanding of the needs related to commercial quality control.

Hands on experience conducting forced degradation studies, granule and dosage form assay and tablet dissolution.

Working knowledge of GMPs, quality, compliance, and data integrity related to recent trends in the pharmaceutical industry.

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.

Preferred Experience and Skills

Working knowledge of process by which the products are brought to market from discovery to tech transfer with an understanding of the roles. and responsibilities of the related functional organizations within our manufacturing and development divisions.

Working knowledge of product specification to support drug development and registration.

Expertise in Liquid Chromatography-Mass Spectroscopy (LC-MS) and/or other identification techniques.

Working knowledge of statistics and tools, e.g., design of experiments and/or statistical data treatment and/or Minitab.

Working knowledge of Chemistry Manufacturing & Control (CMC) filing requirements.

Working knowledge of Microsoft and other visualization and data management tools, such as Spotfire.

Experience with analytical techniques for large molecules/biologics.

Experience with project management.

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, digital tools, lab data analytics, etc.

Familiarity or working knowledge of early stages of drug development.

Experience or familiarity with powder and particle technology, sampling and characterization.

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 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)

$76,000.00 - $129,400.00

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:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R531469