Company

Merck & Co., Inc.See more

addressAddressRahway, NJ
type Form of workFull-Time
CategoryInformation Technology

Job description

Job Description
The selected candidate will work in the Analytical Research & Development (AR&D) department within the Development Sciences and Clinical Supplies (DSCS) organization and serve as a primary point of contact for externalized analytical deliverables supporting small molecule drug substance programs at various stages of development. The scope of the role will include realization of the AR&D externalization strategy by leading our business continuity planning for small molecule drug substance. As part of this role the candidate will lead the build of analytical capabilities and drive a culture of scientific excellence at our external partners including oversight of a rapidly growing team of external analysts. The candidate will partner with cross functional Development and Commercialization Teams (DCT's) and external partners to establish timelines for API deliveries and will provide oversight of method development, method transfer, as well as release and stability testing for multiple programs. The candidate will also partner with Process, Engineering, Quality, and interdivisional stakeholders to grow our relationships with select vendors by leveraging our company's ways of working and transform them into strategic partners. This role represents an excellent opportunity for an analytical scientist seeking to gain externalization experience, lead the capability build at an external partner, provide oversight to multiple programs at any given time, and broaden their experience in small molecule chemical development.
Primary Responsibilities:
  • Execution of AR&D's externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals.
  • Partner with cross functional DCT's and Process Research & Development External Capabilities to manage externalized projects.
  • Lead analytical development for all API deliverables sited at selected external partners including analytical method qualifications/transfers, technical oversight, and resolution of analytical issues.
  • Lead analytical capability build at selected external partners by identifying focus areas that support our company's current and future pipeline and working closely with internal SMEs to upskill external partners.
  • Partner with internal AR&D stakeholders to author technical protocols, reports, and review technical documents.
  • Ensure high quality documentation from external partners consistent with a compliance mindset.

Education Minimum Requirements:
  • A Ph.D. with a minimum of 3 years of relevant experience
  • OR a Master's degree with a minimum of 6 years of experience
  • OR a Bachelor's degree with a minimum of 8 years of experience

Preferred Experience & Skills:
  • Outstanding communication, critical thinking, and leadership skills.
  • Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning.
  • Comfort with working in a fast-paced and dynamic environment.
  • Strong knowledge of small molecule CMC landscape including knowledge of GMP, ICH and relevant HA guidelines.
  • Extensive experience with a wide variety of analytical methods, including biochemical, biophysical characterization.
  • Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines.
  • Travel (Domestic and/or International) up to 10% of time.

#AR&D
NOTICEFORINTERNALAPPLICANTS
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
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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
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:
$122,800.00 - $193,300.00
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.
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:
Shift:
Valid Driving License:
Hazardous Material(s):
Refer code: 9213114. Merck & Co., Inc. - The previous day - 2024-05-08 00:09

Merck & Co., Inc.

Rahway, NJ
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