Job Description

Position Description:

Senior Scientist, Sterile Drug Product Commercialization

The Sterile Drug Product Commercialization group within our Manufacturing Division is based out of West Point, PA and is the division's leader in Sterile Product and Process Development, process scale up, and technology transfer.

The department is a key enabler of new market authorizations and product launches, while providing technical support and product life cycle management for all injectables in our sterile drug products portfolio. The group is responsible for establishing the science, engineering and knowledge required for today's innovative and accelerated commercialization of novel Vaccines, Biologics, and Pharmaceutical products and combination products. The Senior Scientist is responsible to establish and execute commercial process development studies for targeted pipeline and inline programs and transfers robust and scalable manufacturing processes while minimizing time to launch.

Job Duties include but are not limited to the following:

• Executes drug product (DP) development and commercialization studies, new product introduction and process validation at commercial sites

• Designs and conducts experiments to establish robust commercial sterile drug product processes and integrated control strategies | Leads or attends pharmaceutical product working groups

• Manages DP activities for in line and pipeline programs, including completion of regulatory filings and product life-cycle management

• Authors technical protocols for studies, ensures appropriate design of experiments and sample size selection | Ensures acceptance criteria for study outcomes are pre-defined (e.g. performance parameter range, systematic result range etc.)

• Sample submission and tracking. Employs statistical tools and methods to evaluate results

• Authors technical reports that can be used as source documentation for regulatory filing | Ensures technical information is clearly understood and integrated into result finding

• Conducts second-person review (SPR) for high-quality CMC sections for regulatory submissions

• Ensures commercialization programs meet requirements related to science, quality, reliability, schedule and cost

• Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced knowledge gained on scientific/technical issues to guide others to address non-routine and/or difficult issues

• Serves on cross functional teams to promote strategic initiatives

• Drives continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination products presentations

• Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion

Position Qualifications:

Education Minimum Requirement:

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six years relevant experience; or

• Master degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with four years relevant experience; or

• Ph.D. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with relevant academic experience

Required Experience and Skills:

• Working knowledge in process optimization, scale-up and technology transfer of sterile or bipharmaceutical processes to pilot/commercial

• Work objectively and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect

• Analytical problem-solving skills

Preferred Experience and skills:

• Knowledge in Good Documentation Practices (GDPs)

• Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and ICH guidelines

• Expertise with utilization of QbD principles for process development

• Expertise in authoring and reviewing CMC regulatory documentation

• Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.

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.

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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:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:10/03/2024

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:R313138