Senior Scientist, External Capabilities Analytical R&D (Hybrid)
Job DescriptionThe Senior Scientist, Analytical External Capabilities, serves as the primary point of contact for all outsourced analytical efforts from the research and development laboratories working on the development of Biologics, and some more complex large molecule therapeutics.
The qualified candidate will be responsible for coordination of analytical outsourcing to support development programs from preclinical candidate through late phase filing.
The responsibilities include coordination of analytical outsourcing strategy including oversight of method development, release testing, stability, extended characterization, forced degradation studies, in-process testing, and formulation development support through the strong collaboration with our Company's external partners.
The candidate will be expected to effectively communicate with stakeholders in external and internal partner organizations.
This role represents an excellent opportunity for an analytical scientist wishing to gain a breadth of experience in drug development.
Primary
Responsibilities:
Collaborate with external analytical partners to provide analytical capabilities and capacity to support our Company's internal research and development programs.
Partner with our Company's analytical and process teams to coordinate the outsourcing of analytical testing and development of analytical methodology.
Provide technical and QC oversight and troubleshoot analytical issues with external vendors, engaging the internal analytical development teams where needed.
Develop the analytical strategies and manage all analytical deliverables for given program(s) in a matrix team environment Executing analytical method qualifications and transfers between company sites and CROs.
Writing technical protocols, reports, Standard Operating Procedures (SOPs), etc.
Track project timelines and external work Track and summarize external data for our Company's project teams Present our Company's teams with progress at regular program meetings Ensure high quality documentation and analytical results from the external entity Communicate and manage atypical and out of specification test results according to the appropriate departmental procedures.
Education Minimum Requirements:
PhD with relevant experience Masters with 3
years relevant experience Bachelors with 5
years relevant experience Experience Skills KnowledgeRequired Principled and effective communication and leadership skills in a dynamic environment Demonstrated track record of working across networks both internally and externally Preferred Experience & Skills:
Strong knowledge of biologics CMC requirements and experience in supporting health authority filings.
Experience with development of robust and reliable Biologics analytical assays Managing analytical projects in the biotech/pharmaceutical industry under GMP regulations Experience with a wide variety of methods, including biochemical, biophysical and biological activity assays.
NOTICEFORINTERNALAPPLICANTSIn 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 separationpackage, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
#EBRG #AR&DEmployees 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 HERECurrent Contingent Workers apply HEREUS 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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
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 salary range:
$107,600.
00 - $169,400.
00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State ActsSearch 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/A Recommended Skills Biochemical Assays Biochemistry Biology Biotechnology Communication Drug Development Estimated Salary: $20 to $28 per hour based on qualifications.
The qualified candidate will be responsible for coordination of analytical outsourcing to support development programs from preclinical candidate through late phase filing.
The responsibilities include coordination of analytical outsourcing strategy including oversight of method development, release testing, stability, extended characterization, forced degradation studies, in-process testing, and formulation development support through the strong collaboration with our Company's external partners.
The candidate will be expected to effectively communicate with stakeholders in external and internal partner organizations.
This role represents an excellent opportunity for an analytical scientist wishing to gain a breadth of experience in drug development.
Primary
Responsibilities:
Collaborate with external analytical partners to provide analytical capabilities and capacity to support our Company's internal research and development programs.
Partner with our Company's analytical and process teams to coordinate the outsourcing of analytical testing and development of analytical methodology.
Provide technical and QC oversight and troubleshoot analytical issues with external vendors, engaging the internal analytical development teams where needed.
Develop the analytical strategies and manage all analytical deliverables for given program(s) in a matrix team environment Executing analytical method qualifications and transfers between company sites and CROs.
Writing technical protocols, reports, Standard Operating Procedures (SOPs), etc.
Track project timelines and external work Track and summarize external data for our Company's project teams Present our Company's teams with progress at regular program meetings Ensure high quality documentation and analytical results from the external entity Communicate and manage atypical and out of specification test results according to the appropriate departmental procedures.
Education Minimum Requirements:
PhD with relevant experience Masters with 3
years relevant experience Bachelors with 5
years relevant experience Experience Skills KnowledgeRequired Principled and effective communication and leadership skills in a dynamic environment Demonstrated track record of working across networks both internally and externally Preferred Experience & Skills:
Strong knowledge of biologics CMC requirements and experience in supporting health authority filings.
Experience with development of robust and reliable Biologics analytical assays Managing analytical projects in the biotech/pharmaceutical industry under GMP regulations Experience with a wide variety of methods, including biochemical, biophysical and biological activity assays.
NOTICEFORINTERNALAPPLICANTSIn 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 separationpackage, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
#EBRG #AR&DEmployees 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 HERECurrent Contingent Workers apply HEREUS 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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work ModelEffective September 5,2023 our U.
S.
Hybrid work model will be as follows:
1.
Three total days on site per week:
Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams.
2.
Fridays will formally be a remote-working day unless business critical tasks require onsite presence.
Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
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 salary range:
$107,600.
00 - $169,400.
00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
For Washington State Jobs, a summary of benefits is listed here.
Learn more about your rights, including under California, Colorado and other US State ActsSearch 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/A Recommended Skills Biochemical Assays Biochemistry Biology Biotechnology Communication Drug Development Estimated Salary: $20 to $28 per hour based on qualifications.
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