Job Description
As part of our Company's Manufacturing Division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. The SDPC team is based out of West Point PA, USA with a presence in Carlow, Ireland supporting Irish and European Sterile Drug Product manufacturing sites.
The SDPC group is the division's leader in sterile product and process development, responsible for commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today's innovative and accelerated commercialization of novel vaccines, biologics, pharmaceutical products, and combination products. The SDPC group supports the growing pipeline of diverse products and evolving technologies.
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We are seeking a Senior Scientist to be the lead drug product scientist responsible for establishing and executing commercial process development studies for targeted biologics pipeline and inline programs. The Senior Scientist will develop and transfer robust and scalable manufacturing processes while minimizing time to launch and implement process improvements to reduce cost structure and enhance process robustness.
This position may require travel up to 25%. Must be able to travel for this position.
Accountabilities and Responsibilities for this position include but are not limited to the following:
- Designs and executes studies to develop and characterize sterile drug product processes, including the establishment of the commercial integrated control strategy.
- Develops and transfers robust processes to the Drug Product (DP) commercial manufacturing site.
- Builds strategy and technical framework for process validation at commercial sites
- Manages DP activities for in line and pipeline programs, including completion of regulatory filings and product life-cycle management.
- Ensures appropriate experimental design principles including DOE are used where applicable.
- Ensures fit-for-purpose scale-down models are developed and employed.
- 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, analytical result range etc.).
- Responsible for sample submission and tracking. Employs statistical tools and methods to analyze results.
- Authors technical reports that can be used as source documentation for regulatory filing.
- Ensures technical information is clearly understood and integrated into decision making.
- Authors or performs second-person review (SPR) for high-quality CMC sections for regulatory submissions.
- Establishes and validates platform engineering and scientific models for sterile product and process commercialization.
- 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 experience gained on scientific/technical issues to guide others to address non-routine and/or difficult issues.
- Serves on cross functional teams to support 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.
Minimum Education Requirement and Experience:
- Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six (6) years of relevant experience OR
- Master of Science (M.S.) degree in chemical engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with four (4) years of relevant experience OR
- Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with relevant academic experience and no industry experience
Preferred Experience and Skills:
- Experience in process optimization, scale-up and technology transfer of sterile biologics products to pilot/commercial scale.
- Experience in the process development and manufacturing of large biological molecules, with an understanding of protein attributes.
- Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
- Experience with utilization of QbD principles to process development and life cycle management
- Experience in authoring and reviewing CMC regulatory documentation.
- Project management and activities management skills (dashboards, activity trackers)
- Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
- Competency in problem solving skills and technical writing.
- 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.
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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, 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:
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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.
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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, 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 - $175,300.00
Available 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.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los 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 Ordinance
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:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/29/2024
*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:R317625