Job Description

Job Description

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 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 the Pennsylvania location. 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'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 and report data treatment and interpretation to support problem resolution and decision making

Minimum Education:

* Ph.D. in Analytical Chemistry or related discipline with 0-3 years relevant work experience or;

* Master's with 3+ years of pharmaceutical experience API and/or drug product or;

* Bachelor's with 7+ pharmaceutical experience API and/or drug product

Experience and Skills

* 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 and Skills:

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

* 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, eg. 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

* Identifying, implementing and/or sustaining new lab technologies such as automation, rapid tests, etc.

NewCo

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
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We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R91634