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Job Description

The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Principal Scientist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

In this role as a Principal Scientist, you will be part of a team develop­ing innovative analytical methodologies for early to late phase pro­grams with application to drug substance and a broad array of drug product dosage forms, combination products and modalities through analytical characterization, imaging tools, and data analy­sis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities include:

• Driving solutions to analytical development challenges for small molecules, peptides, mRNA, oligonucleotides, and bioconjugates using conventional and novel technologiesthrough active collaboration with cross functional project teams and external vendors.

• Designing scientific studies to inform the selection and deep understanding of synthetic routes, to inform the selection of early development and market formulation compositions and manufacturing processes, documented in a detailed and timely manner.

• Develop and implement analytical methods utilized for both development as well as methods for the re­lease and shelf-life assessment of clinical supplies under good manufacturing practice (GMP) settings.

• Providing analytical leadership not only on drug development pipeline projects, but also innovative technology teams shaping analytical methods and tools of the future. ​

• Author investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/ worldwide marketing application (WMA) submission documents across the project development lifecycle, as well as responding to agency questions.

• Strong collaboration with internal stakeholders and external partners.

• Presenting results of experiments and innovation efforts to project teams and at various cross-functional forums.

• Scientific supervision and day-to-day oversight of junior analytical scientists.

• Present results of experiments and innovation efforts to teams and internal governance bodies.

• Partnering with managers to shape development strategies

• Be a leader within the external scientific community in professional organizations, conferences, and publica­tions as well as analytical technology and regulatory sciences related focus groups and consortia.

Qualifications

Education Minimum Requirements ​

Applicants must hold one of: ​

• PhD Degree in Analytical/Biochemistry/Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience​.

• Master’s Degree in in Analytical/Biochemistry/Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience. ​

• Bachelor’s Degree in in Analytical/Biochemistry/Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industry experience. ​

Required Experience and Skills

A strong team player with excellent written and oral communication skills, as well as strong leadership and interpersonal skills are necessary to qualify for this role. Additional skills:

• Strong background in analytical control strategy development and execution

• Demonstrated ability to develop talent through good mentoring skills

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development

• A proven record of strong technical problem solving and innovative research experience, supported by scientific publications.

• Ability to work both independently for development of analytical methodologies and cross-functionally for successful transfer methods. Plan optimization and documentation to meet program deadlines.

• Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.

• Experience with matrix management and peer to peer coaching

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills ​

While not required, experience in one or more of the following areas is preferred: ​

• Hands-on chromatography (e.g., LC, GC) method development, analysis and troubleshooting. ​

• Other advanced analytical techniques such as mass spectrometry or dissolution. ​

• Experience in development and characterization of small and/or large molecules, mRNA, and/or antibody drug conjugates​

• Established scientific reputation supported by publications and external presentations

• Experience in high-throughput experimentation and data-rich experimentation, or data science

#EligibleforERP

#AR&D

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

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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, generally Tuesday, Wednesday and either Monday or 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 presence. This 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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$149,400.00 - $235,100.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .

Search Firm Representatives Please Read Carefully

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.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

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Hazardous Material(s):

Job Posting End Date: 05/25/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R291752