Job DescriptionThe Global Quality- Large Molecule Analytical Sciences (GQ-LMAS) team leads the global analytical technical oversight of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support for Large Molecules (Vaccines and Biologics), and Cross-Modality Compounds (i.e. Antibody-Drug Conjugates).This team is highly motivated, fast-paced and focused on a robust analytical testing network that enables our company’s strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial product. This External Analytical position will direct and manage the analytical activities within our commercial external manufacturing and testing network. This role involves developing and implementing site-related analytical strategies, and site implementation of continuous improvement in analytical methods and techniques and driving successful analytical execution by the contract testing lab(s) to support on time batch release and stability.Additionally, this position will work directly with technical operations, quality, regulatory, microbiology, and analytical program leaders on a regular basis to review/approve critical documents relating to analytics and participate as a site representative for method life-cycle related tasks.Responsibilities include but are not limited to:
Analytical technical oversight working directly with the external provider(s) and internal cross-functional stakeholders to support analytical testing of large molecule (biologics and/or vaccine) products.
Position includes significant on-site presence at external testing provider(s) to support direct engagement and technical oversight of critical analytical testing activities.
Build and maintain strong relationship with External Entities, as well as internal operations, technology, analytical and procurement organizations. Closely collaborates with appropriate business and functional areas to conduct Tier meetings, and Joint Steering Committee meetings (as applicable) to achieve our objectives.
Collaborate with departmental and cross-functional commercial manufacturing teams to support facility start-up and sustainability activities.
Interface with Global Analytical Working Groups and Global Method Owners/SMEs
Drive continuous improvement initiatives to enhance the quality and robustness of external /testing through implementation of proactive tools, assay data trending, corrective actions and best practices.
Identify and resolve analytical issues, deviations, and out-of-specification results from external testing labs through technical support of investigating and troubleshooting analytical problems to ensure the accuracy and reliability of test results.
Lead/support complex investigations and drive resolution of analytical technical issues
Build and manage project plans, timelines, and schedules to effectively meet project timelines and deliverables.
Ensure our external testing sites are prepared for inspections from multiple agencies (i.e. FDA, EMA, PMDA) from an analytical technical perspective
Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ), licensure and regulatory technical questions.
Minimum Education Required and Experience:
Bachelor’s Degree (BA/BS) with a concentration in biology, chemistry, biochemistry, or related science with six (6) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
Master’s Degree (MA/MS) with a concentration in biology, chemistry, biochemistry, or related science with four (4) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation; OR
PhD with a concentration in biology, chemistry, biochemistry, or related science with two (2) years of relevant industry knowledge working in the field of analytical testing, development, transfer, and/or validation.
Required Skills and Experience:
At least 4 years working experience in a GXP laboratory environment in the area of large molecules (vaccines, biologics) analytics or Cross-Modality Compounds.
Experience in analytical product life cycle activities (development, validation, and /or transfer) across various large molecule analytical platforms (i.e. ELISA, HPLC, CE).
Understanding biologics analytical technology such as bioassay (i.e. ELISA, cell-based methods), chromatography (i.e. HPLC, UPLC), and general biochemistry methods.
Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, and/or Quality control.
Knowledge with In-Process Controls, drug substance and drug product release, stability, and extended characterization testing for vaccines and biologics
Experience with regulatory requirements and guidelines according to ICH, USP, Ph. Eur., and JP.
Strong organizational and project management skills to handle multiple project associated tasks simultaneously.
Strong oral and written communication skills to effectively communicate technical information and risks to both technical and non-technical stakeholders.
Preferred Skills and Experience:
Knowledge of deviation management and change control processes.
Ability to analyze, interpret, and troubleshoot analytical data.
Experience in method transfer, method validation, new product introduction, and/or analytical product life cycle activities across various large molecule franchises and analytical platforms.
Worked and interfaced with external partners (i.e. CMOs and CTLs).
Self-motivated with a positive, proactive, and service-oriented mindset.
Capability to adapt and be flexible in a fast paced cross-functional team working environment.
Experience with laboratory data management systems (i.e., LIMS).
Experience with software automation/digital systems (e.g., Veeva Vault, MEDs, IPI, Spotfire).
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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 (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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 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.Expected US salary range:$111,400.00 - $175,300.00Available 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 (https://www.benefitsatmerck.com/) .San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos 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 OrdinanceSearch Firm Representatives Please Read CarefullyMerck & 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:DomesticVISA Sponsorship:NoTravel Requirements:50%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:12/10/2024A 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: R323968