Location: West Point
Company: Merck
Areas, Animal Health) While Optimizing Our Base Business)Adapt Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape Diverse Talent We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world.
Values and Standards Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us 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 initiative-taking, 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 inline large molecule (vaccine and biologic) separations methods (e. g. HPLC, UPLC, CE, ic
IEF). 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 separations assays (e. g. liquid chromatography (HPLC, UPLC), capillary electrophoresis (CE), imaged capillary isoelectric focusing (ic IEF))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 and Experience: Bachelor of Science (BS) degree in biology, chemistry, biochemistry, or related science with five (5) years working in current Good Manufacturing Practices (c GMP) laboratory environment in large molecules (vaccines, biologics) with knowledge in chromatographic analytical methods; OR Master of Science (MS) degree in biology, chemistry, biochemistry, or related science with three (3) years working in current Good Manufacturing Practices (c GMP) laboratory environment in large molecules (vaccines, biologics) with knowledge in chromatographic analytical methods.
Required Experience Knowledge Skills: In-depth expertise with separations techniques specifically HPLC, UPLC, CE, ic IEF, and other separations-based assay technology for large moleculeinteractionperience with Chromatography Data Systems (e. g. Empower, Astra, Chromeleon)Late-stage method development, validation, transfer, and troubleshooting.
Preferred Experience Knowledge Skills: Theoretical understanding of other biochemical (non-separations based) assays. Authoring and review of technical documents Ability to work objectively, independently, and within a cross-functional team and learn new techniques. Good technical, communication (oral and written), interpersonal, and teamwork skills. Initiative-taking with a positive attitude and proven performance record. Strong organizational and project management skills. Ability to effectively identify and communicate risks. 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.
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, interaction, interactionual 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" 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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Requisition ID: R272266PDN-9ad3c00f-20fc-4e48-b0a3-bac810e8f23c
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