Senior Scientist, Bioprocess Drug Substance Commercialization | Alabaster, AL

Drivers (Oncology, Vaccines, Select Specialty 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 Strategic Summary

Contributes to commercialization activities of late-stage pipeline and /or commercial manufacturing support for biologically derived drug substances (e.

g.

therapeutic proteins or vaccines). For late-stage pipeline commercialization, activities include process characterization, technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring. Key Responsibilities

Technical influence on design, planning, and executing laboratory experiments and investigations for the purposes of generating new data and knowledge to enable process development, problem solving, and to reduce risk inherent in scale up or scale down of drug substance processes Authors experimental protocols and documents work in a lab notebook Documents lab activities, findings and conclusions in scientific reports, and presents knowledge at appropriate forums Ensures proper documentation and compliance with current good manufacturing practices (c GMPs) guidelines and federal, state, and local regulations Managing large multifaceted projects as the leader of a cross-functional team As a peer contributor, may be concerned with clearly identifiable elements or functions within a larger project team Oversee and coordinate work completed by contractors May require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing GMP responsibilities include authoring, reviewing and approving technical and regulatory documents Education Bachelor's degree in Engineering, Science or related field with four years relevant experience or Master degree with three years relevant experience or Doctoral Degree (Ph.

D) with noexperience Required Experience and Skills Work independently and as a Team member with Integrity Precision Accomplishment Motivational Ambition Respect Principled verbal and written communicationinteractionperience with lab scale experimental implementation Basic statistical analysis and presentation of results Preferred Experience and Skills Large molecule process development experience including the use of Design of Experiments (DOE) techniques, and Quality by Design (Qb D)Experience with on-the-floor GMP manufacturing support 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.

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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.

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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: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: On-Site Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Requisition ID: R271388PDN-9ae1d60a-e279-42d9-88bc-b5cf56e2abc7