Scientist, Sterile Drug Product Commercialization (Hybrid)
Job Description
As part of Our Company's Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for Vaccines, Biologics, and sterile Pharmaceutical products. It 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, and Pharmaceutical products and combination products.
The Scientist in Sterile Drug Product Commercialization is a drug product scientist responsible to design and execute commercial product and process development studies for targeted pipeline and commercial programs. Develops robust and scalable manufacturing processes while minimizing time to launch. Implements process improvements to reduce cost structure and enhance robustness process.
Accountabilities and Responsibilities for this position 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.
Attends drug product working groups.
Designs and executes process characterization activities. Ensures appropriate 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.
Provides on-site support during manufacturing activities (purposeful presence)
Ensures safety and documentation compliance with performing experiments in the lab and technical writing, including close-out of electronic lab notebook experiments.
Contributes to a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.
Education:
B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 2 years of relevant experience; or
Master's degree (non-thesis) in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 1 year of relevant experience; or
Master's degree (thesis) in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with relevant academic experience.
Preferred Expertise:
Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
Knowledge of combination product development
Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles
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.
Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes
Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing).
Working understanding of analytical methods to characterize vaccines, biologics and other sterile drug products.
This position may require travel up to 20% Must be able to travel for this position.
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.
VETJOBS
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, 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
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:
Yes
Hazardous Material(s):
N/AEstimated Salary: $20 to $28 per hour based on qualifications.
As part of Our Company's Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process leadership and laboratory capabilities for late stage and commercial drug product processes for Vaccines, Biologics, and sterile Pharmaceutical products. It 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, and Pharmaceutical products and combination products.
The Scientist in Sterile Drug Product Commercialization is a drug product scientist responsible to design and execute commercial product and process development studies for targeted pipeline and commercial programs. Develops robust and scalable manufacturing processes while minimizing time to launch. Implements process improvements to reduce cost structure and enhance robustness process.
Accountabilities and Responsibilities for this position 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.
Attends drug product working groups.
Designs and executes process characterization activities. Ensures appropriate 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.
Provides on-site support during manufacturing activities (purposeful presence)
Ensures safety and documentation compliance with performing experiments in the lab and technical writing, including close-out of electronic lab notebook experiments.
Contributes to a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion.
Education:
B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 2 years of relevant experience; or
Master's degree (non-thesis) in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 1 year of relevant experience; or
Master's degree (thesis) in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with relevant academic experience.
Preferred Expertise:
Experience in biologics drug product fill finish process optimization, scale-up and technology transfer of sterile products to pilot/commercial.
Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
Knowledge of combination product development
Working knowledge of regulatory requirements for commercialization and registration of sterile drug products, including application of Quality by Design principles
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.
Working knowledge of statistical methods for DOE design and data analysis, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for manufacturing processes
Experience in Data Analytics, Computer Modeling, and Digital Applications (e.g. 3-D printing).
Working understanding of analytical methods to characterize vaccines, biologics and other sterile drug products.
This position may require travel up to 20% Must be able to travel for this position.
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.
VETJOBS
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, 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
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:
Yes
Hazardous Material(s):
N/AEstimated Salary: $20 to $28 per hour based on qualifications.
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