Director, Large Molecule Analytical Validation Design
Job Description The Large Molecule Analytical Validation (LMAV) team within Analytical Research & Development (AR&D) is seeking a highly motivated and experienced Director to lead a team to design and own the validation strategy for our company's Large Molecule Pipeline.
The primary role of the successful candidate will be to lead the validation design, including composition of the associated documentation to deliver compliant and robust analytical validations and initial transfers.
Multiple cross divisional close partnerships are a pivotal part of the role to ensure successful validation strategy from development up to and including late-stage analytical validation to enable commercialization of the pipeline.
The position will lead a multi-region and country team of 10-15 FTE.
Note:
This position is available in West Point, PA; Rahway, NJ; or Ireland based on candidate's current domestic location preference.
Responsibilities include, but are not limited to, the following:
Cultivate and foster relationships with key partners across divisions to build a collaborative relationship that aligns to the End-to-End Transformations, addressing the needs of the pipeline
Lead and manage a diverse team, managing relationships with key partners, building collaborative partnerships to align/develop the validation design addressing the needs of the pipeline
Strategic alignment of cross functional teams (e.
g.
, B-AR&D, V-AR&D, Global Quality Analytical Sciences) to identify validation risks, remove obstacles, develop solutions, and perform assessments to ensure a robust validation design
Lead the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching.
Interface with key stakeholders to drive innovation for seeking process efficiencies and solving complex challenges that have broad impact on the business
Alignment of cross-divisional sponsorship, develop communication plans and escalation of issues, as required
Ownership of electronic documentation system standards & templates, providing a streamlined process
Cross divisional collaboration on Analytical Procedure Life Cycle (APLC) and assay monitoring, including prioritization of in-line remediation.
Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects Education:
B.
S.
in science or related discipline with 12 years of relevant experience in the biopharmaceutical industry
M.
S.
science or related discipline with eight (8) years of relevant experience in the biopharmaceutical industry
Ph.
D.
in science or related discipline with six (6) years of relevant experience in the biopharmaceutical industry Required:
A minimum of five (5) years experience working in a GMP regulated environment in a validation leadership role
Ability to provide compliance direction and leadership to the validation team and company-wide in establishing validation strategies based on industry best practices and regulatory expectations
Understanding of laboratory, manufacturing, regulatory affairs, compliance and quality assurance requirements for large molecules
Ability to work in a high paced team environment with cross-divisional & functional interactions
Ability to deliver complex objectives under challenging timelines in a rapidly changing environment
Motivates team members and promotes the value of working together as a team and relationship building, using the diverse perspectives of others to generate ideas
Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills Preferred:
M.
S.
or Ph.
D.
Experience with qualification, validation, and transfer of assays per ICH and USP
Experience with large molecule modalities (i.
e.
, biologics, vaccines, ADC) 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 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.
#AR&D 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 (https:
//wd5.
myworkday.
com/msd/d/inst/1422$1533/rel-task/3001$14.
htmld) />Current Contingent Workers apply HERE ( https:
//wd5.
myworkday.
com/msd/d/task/1422$4020.
htmld) /> 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 ( https:
//survey.
sogosurvey.
com/r/aCdfqL) 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 Rights ( https:
//www.
eeoc.
gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.
pdf) />EEOC GINA Supplement? Pay Transparency Nondiscrimination (https:
//www.
dol.
gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.
pdf) 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 anothers thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work Model Effective 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 candidates relevant skills, experience, and education.
Expected salary range:
$159,200.
00 - $250,700.
00 Available 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 ( https:
//www.
benefitsatmerck.
com/).
Learn more about your rights, including under California, Colorado and other US State Acts ( https:
//www.
msdprivacy.
com/us/en/CCPA-notice/) /> 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 Requisition ID:
R252604 Recommended Skills Assessments Communication Creativity Hardworking And Dedicated Immunization Interpersonal Skills Estimated Salary: $20 to $28 per hour based on qualifications.
The primary role of the successful candidate will be to lead the validation design, including composition of the associated documentation to deliver compliant and robust analytical validations and initial transfers.
Multiple cross divisional close partnerships are a pivotal part of the role to ensure successful validation strategy from development up to and including late-stage analytical validation to enable commercialization of the pipeline.
The position will lead a multi-region and country team of 10-15 FTE.
Note:
This position is available in West Point, PA; Rahway, NJ; or Ireland based on candidate's current domestic location preference.
Responsibilities include, but are not limited to, the following:
Cultivate and foster relationships with key partners across divisions to build a collaborative relationship that aligns to the End-to-End Transformations, addressing the needs of the pipeline
Lead and manage a diverse team, managing relationships with key partners, building collaborative partnerships to align/develop the validation design addressing the needs of the pipeline
Strategic alignment of cross functional teams (e.
g.
, B-AR&D, V-AR&D, Global Quality Analytical Sciences) to identify validation risks, remove obstacles, develop solutions, and perform assessments to ensure a robust validation design
Lead the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching.
Interface with key stakeholders to drive innovation for seeking process efficiencies and solving complex challenges that have broad impact on the business
Alignment of cross-divisional sponsorship, develop communication plans and escalation of issues, as required
Ownership of electronic documentation system standards & templates, providing a streamlined process
Cross divisional collaboration on Analytical Procedure Life Cycle (APLC) and assay monitoring, including prioritization of in-line remediation.
Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects Education:
B.
S.
in science or related discipline with 12 years of relevant experience in the biopharmaceutical industry
M.
S.
science or related discipline with eight (8) years of relevant experience in the biopharmaceutical industry
Ph.
D.
in science or related discipline with six (6) years of relevant experience in the biopharmaceutical industry Required:
A minimum of five (5) years experience working in a GMP regulated environment in a validation leadership role
Ability to provide compliance direction and leadership to the validation team and company-wide in establishing validation strategies based on industry best practices and regulatory expectations
Understanding of laboratory, manufacturing, regulatory affairs, compliance and quality assurance requirements for large molecules
Ability to work in a high paced team environment with cross-divisional & functional interactions
Ability to deliver complex objectives under challenging timelines in a rapidly changing environment
Motivates team members and promotes the value of working together as a team and relationship building, using the diverse perspectives of others to generate ideas
Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills Preferred:
M.
S.
or Ph.
D.
Experience with qualification, validation, and transfer of assays per ICH and USP
Experience with large molecule modalities (i.
e.
, biologics, vaccines, ADC) 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 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.
#AR&D 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 (https:
//wd5.
myworkday.
com/msd/d/inst/1422$1533/rel-task/3001$14.
htmld) />Current Contingent Workers apply HERE ( https:
//wd5.
myworkday.
com/msd/d/task/1422$4020.
htmld) /> 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 ( https:
//survey.
sogosurvey.
com/r/aCdfqL) 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 Rights ( https:
//www.
eeoc.
gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.
pdf) />EEOC GINA Supplement? Pay Transparency Nondiscrimination (https:
//www.
dol.
gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.
pdf) 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 anothers thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
U.
S.
Hybrid Work Model Effective 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 candidates relevant skills, experience, and education.
Expected salary range:
$159,200.
00 - $250,700.
00 Available 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 ( https:
//www.
benefitsatmerck.
com/).
Learn more about your rights, including under California, Colorado and other US State Acts ( https:
//www.
msdprivacy.
com/us/en/CCPA-notice/) /> 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 Requisition ID:
R252604 Recommended Skills Assessments Communication Creativity Hardworking And Dedicated Immunization Interpersonal Skills Estimated Salary: $20 to $28 per hour based on qualifications.
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