4 Principal Scientist, Upstream Vaccine Process Development Jobs in West Point, PA
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Principal Scientist, Upstream Vaccine Process Development
$123k-156k (estimate)
Full Time | Pharmaceutical
5 Days Ago
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Merck is Hiring a Principal Scientist, Upstream Vaccine Process Development Near West Point, PA
Job DescriptionApplications are sought for an opportunity in the Vaccines & Advanced Biotechnologies - Process Research & Development (VAX PR&D) department, which is part of our Company's Research Labs division. The individual will support our Company's discovery & development efforts for Vaccine programs at West Point, PA.
Under the direction of the Sr. Director, individual will lead upstream process development of recombinant sub-unit and/or microbial-based vaccine candidates. The successful candidate will serve as the lead of a group of upstream scientists and engineers whose deliverables include the development of robust, efficient, scalable processes for recombinant sub-unit and/or microbial-based vaccine production including the manufacture of cGMP clinical bulks and tech transfer processes to clinical or commercial manufacturing facilities. Duties may include pre-clinical and clinical process development, process scale-up and engineering, PAT implementation, development of innovative process monitoring and/or process control strategies, cGMP document preparation and modifications, and technology transfer to manufacturing. The successful candidate may also be responsible for the leadership of cross-functional technical working groups. In this role, the individual may function as an individual contributor or technical/scientific lead of a process development team.
Primary Responsibilities Include, But Are Not Limited To
Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. Travel may be required. This position may require occasional off-hour and weekend work.
Education Minimum Requirement
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.Current Employees apply HERE
Current Contingent Workers apply HERE
US And Puerto Rico Residents OnlyOur 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.
AboutWe 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 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, 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 StatusRegular
Relocation:VISA SponsorshipTravel Requirements:Flexible Work ArrangementsHybrid
ShiftValid Driving License:Hazardous Material(s)Job Posting End Date:06/26/2024
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:R284133
Under the direction of the Sr. Director, individual will lead upstream process development of recombinant sub-unit and/or microbial-based vaccine candidates. The successful candidate will serve as the lead of a group of upstream scientists and engineers whose deliverables include the development of robust, efficient, scalable processes for recombinant sub-unit and/or microbial-based vaccine production including the manufacture of cGMP clinical bulks and tech transfer processes to clinical or commercial manufacturing facilities. Duties may include pre-clinical and clinical process development, process scale-up and engineering, PAT implementation, development of innovative process monitoring and/or process control strategies, cGMP document preparation and modifications, and technology transfer to manufacturing. The successful candidate may also be responsible for the leadership of cross-functional technical working groups. In this role, the individual may function as an individual contributor or technical/scientific lead of a process development team.
Primary Responsibilities Include, But Are Not Limited To
- People manager of a team (~5 scientists)
- Serve as a technical lead in the areas of vaccines and advanced biotechnologies process development, characterization, and technology transfer.
- Drive the development of new principles, concepts, and methods to enable process development, scale-up of processes to pilot scale, and technology transfer to manufacturing scale.
- Develop robust and scalable manufacturing processes while minimizing time to file and launch.
- Identify and lead strategic initiatives and innovation in the area of vaccine and advanced biotechnology process development.
- Represent functional area in cross-functional teams engaged in advancing novel vaccine and advanced biotechnology development.
- Actively network with both internal and external counterparts (i.e. biopharma industry, academia).
- Continuously monitor scientific and regulatory landscape and actively present (premier conferences), publish (peer-reviewed journals), and patent
- Author required regulatory and technical documentation. Ensures that process/product are developed and documented according to our company's standard practices.
- Provide mentorship, technical oversight and strategic guidance to direct reports.
- Handle multiple priorities and balance work to achieve business goals.
Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. Travel may be required. This position may require occasional off-hour and weekend work.
Education Minimum Requirement
- Must have a BS or MS or PhD in engineering or biological sciences
- For BS, at least twelve (12) years of experience in biotechnology related position
- For MS, at least ten (10) years of experience in biotechnology related position
- For PhD, at least eight (8) years of experience in biotechnology related position
- Must have strong scientific understanding of cell-based expression systems, biotherapeutic and/or vaccine production, and experience with practical hands-on process development
- Excellent scientific understanding of upstream cultivation techniques
- At least 4 years of hands-on experience in cell-based biological production processes
- Working knowledge of downstream operations
- Prior experience of statistical design of experiments
- Strong understanding of or experience in technology transfer and cGMP manufacturing at clinical or commercial scale
- Experience in mentoring/managing teams of scientists/engineers
- Prior experience in process scale-up
- Prior experience in the development of microbial-based production processes including a scientific understanding of cell biology for biotherapeutic/vaccine production including cell metabolism and molecular biology
- Prior experience with microbial and yeast-based expression systems and/or cultivation techniques
- Prior experience implementation of PAT and/or applying “-omics” approaches to solve upstream bioprocess challenges
- Experience in authoring and reviewing CMC regulatory documentation
- People manager and/or technical lead of process development team
- Project management experience including participation and/or leadership of technical working groups
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.Current Employees apply HERE
Current Contingent Workers apply HERE
US And Puerto Rico Residents OnlyOur 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.
AboutWe 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 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, 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 StatusRegular
Relocation:VISA SponsorshipTravel Requirements:Flexible Work ArrangementsHybrid
ShiftValid Driving License:Hazardous Material(s)Job Posting End Date:06/26/2024
- 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.
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:R284133
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$123k-156k (estimate)
POST DATE
06/26/2024
EXPIRATION DATE
06/27/2024
WEBSITE
merck.com
HEADQUARTERS
KENILWORTH, NJ
SIZE
>50,000
FOUNDED
1891
TYPE
Public
CEO
KENNETH C FRAZIE
REVENUE
$10B - $50B
INDUSTRY
Pharmaceutical
Related Companies
About Merck
Merck is a New Jersey-based global pharma company that develops and manufactures prescription medicines, novel vaccines, biologic therapies and animal health products.
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