Principal Scientist, Analytical Research & Development

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 firsthand - 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.  

As a Principal Scientist, you will be part of a team developing innovative analytical methodologies for medicines based on small molecules, peptides, mRNA, oligonucleotides and bioconjugates. Our responsibilities range from early stage up to commercialization for both drug substance and a broad array of oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will include: 

Driving our company's Pipeline: 

• Leading analytical teams driving the development of drugs in our company’s pipeline, with a deep understanding of product development from early stage through commercialization.

• Actively partnering with other functional areas to design scientific studies guiding product and process development.

• Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices (including method development and validation as well as specification setting). 

• Authoring 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. 

Scientific Excellence and Regulatory Influence:

• Promoting our company’s scientific excellence and regulatory influence through leadership in the scientific community.

• Advancing and expanding analytical capabilities via the adoption and implementation of novel technologies for product and process characterization.

• Challenging your teams to design and execute the experiments needed to influence programs with data-driven decisions.  

Leadership:

• Mentoring and providing day-to-day oversight of junior analytical scientists.

• Representing your team and/or department via presentations to governance committees and other internal audiences.

• Partnering with director-level management to develop and execute scientific and enterprise strategies. 

• Proactively identifying and escalating program risks.

• Fostering strong collaborations with internal stakeholders and external partners by actively engaging in two-way communication to build trusting relationships.

• Applying a deep understanding of new product development and commercialization to analytical development challenges for small molecules, peptides, mRNA, oligonucleotides, and bioconjugates. Use conventional and novel technologies through active collaboration with cross functional project teams and external vendors.

Qualifications
Education Minimum Requirements 
Applicants must hold one of: 

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

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

• Bachelor’s Degree in Analytical Chemistry, 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:

• Possess deep technical expertise and strategic experience 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

• Strong technical problem solving ability

• A proven record of external scientific engagement demonstrated by scientific publications and presentations. 

• 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

#AR&D

#EligibleforERP

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.

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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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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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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