Principal Scientist, Analytical R&D
Principal Scientist, Analytical R&D
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$ 153800 - 242200
1 Vacancy
Job Description
Job Description
Principal Scientist Small Molecule Analytical Research & Development
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 companys Pipeline:
Leading analytical teams driving the development of drugs in our companys 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 companys 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 technologiesthrough 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 industryexperience.
Masters Degree in Analytical Chemistry Biochemistry Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industryexperience.
Bachelors Degree in Analytical Chemistry Biochemistry Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industryexperience.
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 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 ( GC) method development analysis andtroubleshooting.
Other advanced analytical techniques such as mass spectrometry ordissolution.
Experience in development and characterization of small and/or large molecules mRNA and/or antibody drugconjugates
Established scientific reputation supported by publications and external presentations
Experience in high-throughput experimentation and data-rich experimentation or data science
#AR&D
#EligibleforERP
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
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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
$153800.00 - $242200.00This 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
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Analytical Method Development Applied Engineering Assay Development Bioanalytical Analysis Business Chromatographic Techniques Clinical Judgment Cross-Functional Teamwork Dosage Forms Ethical Compliance Liquid Chromatography (LC) Management Process Matrix Management Mentoring Staff Method Validation Personal Initiative Stability Testing Technical WritingPreferred Skills:
Job Posting End Date:
07/2/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Staff IC
Employment Type
Full-Time
