Assoc Prin. Scientist, Chemistry

Job Description

We are seeking a highly motivated and experienced Associate Principal Scientist to join the Analytical Supply Analytical Sciences API Supply group. This dynamic laboratory-based position offers the opportunity to work in a fast-paced multidisciplinary team focused on solving complex analytical challenges related to the development and validation of Active Pharmaceutical Ingredient (API) manufacturing processes. The focus will be on supporting in-line products as well as launch products. The ideal candidate will have a strong scientific background and will collaborate with both internal and external teams to ensure the successful commercialization of our innovative drug products. This role offers a unique opportunity to make a significant impact in the pharmaceutical industry ensuring compliant robust and efficient supply of critical materials. The Supply Analytical Sciences API Supply group has an Associate Principal Scientist position available at the Rahway NJ site.

Job Function:

The Associate Principal Scientist position is a laboratory-based scientific role in a fast-paced multidisciplinary team environment.

The role is tasked with solving high complexity analytical problems related to the development and validation of API manufacturing processes for the commercialization of our Company innovative drug products.

The incumbent will be expected to interact closely with internal development partners and with internal and external sites in our Company manufacturing network in identifying implementing and troubleshooting laboratory test methods and workflows as well as materials for ensuring compliant robust and responsive supply.

The individual will have a deep understanding of the regulatory and business environment and needs related to API development and commercial supply and provide critical analytical support to ensure the successful commercialization of API manufacturing processes.

Education Minimum Requirement and Experience:

Bachelors Degree in Chemistry or related discipline with ten (10) years of relevant pharmaceutical development experience; OR

Masters Degree in Chemistry or related discipline with five (5) years of relevant pharmaceutical development experience; OR

Doctorate Degree in Chemistry or related discipline with two (2) years of relevant pharmaceutical development experience

Required Experience and Skills:

• Strong chemistry knowledge

• Good Manufacturing Practice (GMP) experience

• Demonstrated problem solving ability including the ability to perform investigations with strong technical troubleshooting skills and to assist in developing/implementing CAPAs

• Experience with common analytical techniques such as chromatography spectroscopy and Karl Fischer

• Strong communication (verbal and written) and interpersonal skills

• Ability to quickly adapt to changes and develop appropriate plans for managing risks

Preferred Experience and Skills:

• Working knowledge of API development and commercialization

• Technical experience that includes LC-MS GC-MS and/or ICP-MS.

• Working knowledge of CMC filing requirements and regulatory guidances (e.g. ICH) for API

• Experience working with CMOs and CROs

• Demonstration of working in cross-functional team

• Strong interpersonal skills including the ability and sensitivity to deal with different cultures

Required Skills:

Preferred Skills:

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U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway 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.

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