Scientist - Container Closure Integrity and Compendia Support

Job Description

Global Quality Large Molecule Analytical Sciences (GQLMAS) in West Point PA, in our Manufacturing Division, is accountable for the inline analytical support of large molecule programs including vaccines and biologics. This team is highly motivated, fast-paced and focused on the rapid advancement of our Company's large molecule pipeline, plus growth of existing products. We also provide in-line analytical sponsorship to enable world-wide robust vaccine and biologics product availability.

This position will involve method optimization, testing, troubleshooting, analytical tech transfer, and analytical procedure lifecycle (APLC) management with a focus on Container Closure Integrity testing (CCIT) and compendial methods. The successful candidate will interface with our QC partners across our Company network and external partners to provide SME support where needed.

Key Responsibilities

• Function as an analytical subject matter expert (SME) troubleshooting and optimizing analytical methods, with a focus on container closure integrity methods and compendial methods.
• Collaborate with cross functional teams to ensure successful tech transfer of analytical methods between QC labs
• Provide technical leadership and mentorship to junior scientists and team members.
• Large Molecule Analytical Procedure Lifecycle (APLC) activities across various franchises and analytical platforms
• Support various biologics and vaccine post-marketed CMC regulatory submissions.
• Lead strategic initiatives within departmental and cross-functional teams representing GQLMAS.

Minimum Education Requirement

• Bachelor of Science (BS) degree in biology, chemistry, biochemistry, or related science with three (3) years working in current Good Manufacturing Practices (cGMP) laboratory environment in large molecules (vaccines, biologics) with knowledge in container closure integrity methods; OR
• Master of Science (MS) degree in biology, chemistry, biochemistry, or related science with one (1) year working in current Good Manufacturing Practices (cGMP) laboratory with knowledge in container closure integrity methods

RequiredExperience | Knowledge | Skills:

• Three (3) years of relevant analytical execution, development, validation, and/or quality control (QC) for container closure integrity and compendia methods as it pertains to Vaccines and/or Biologicals.
• Ability to learn new techniques, troubleshooting assays, author and review technical documents
• Excellent organizational skills to manage multiple projects

Preferred Experience | Knowledge | Skills:

• Hands-on experience in CCIT method development, validation, and troubleshooting for injectable therapeutics. Candidate should be familiar with the following CCIT technologies for this purpose: dye ingress, high voltage leak detection, vacuum decay and pressure decay, laser headspace analysis
  • In-Depth expertise with compendia testing specifically USP , , , , , , and device testing.
  • Good technical, communication (oral and written), interpersonal, and teamwork skills.
  • Ability to effectively identify and communicate risks.
  • Experience with other analytical methodology

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 separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

VETJOBS

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".

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Hazardous Material(s):

Job Posting End Date:

*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.

Job Posting End Date:08/13/2024

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:R307470